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A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma (iinnovate-2)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Modakafusp alfa
Lenalidomide
Bortezomib
Carfilzomib
Daratumumab
Pomalidomide
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Group 1 (NDMM maintenance: modakafusp alfa/lenalidomide) only must have:

    1. NDMM based on standard IMWG diagnostic criteria, have undergone standard of care (SOC) induction therapy including an ASCT, and have achieved a major clinical response.
    2. A history of measurable disease documented at time of diagnosis (before induction and ASCT).
    3. Undergone ASCT within the 12 months of the start of induction therapy and completed ASCT within 180 days before enrollment. Time to initiation of maintenance therapy: participants may start maintenance therapy as early as 60 days after transplant and up to 180 days after transplant. Consolidation cycles are allowed.
    4. Post ASCT MRD positive (10^-5 threshold by local SOC methods or central assessment, if a prior local MRD assessment had not been performed).
    5. No prior progression after initial therapy (at any time before starting maintenance). Participants whose induction therapy was changed due to suboptimal response or toxicity will be eligible if they do not meet criteria for progression. In addition, no more than 2 regimens will be allowed before ASCT, excluding dexamethasone alone.
    6. No prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
    7. Recovered to Grade less than or equal to (<=) 1 autologous stem cell transplant (ASCT) -related toxicities from the reversible effects of ASCT (except for alopecia and amenorrhea).
  2. Groups 2 and 3 (RRMM doublets and RRMM triplets) must have:

    1. Measurable disease, defined as at least one of the following:

      • Serum M-protein >=0.5 g/dL (>=5 g/L) on serum protein electrophoresis (SPEP).
      • Urine M-protein >=200 mg/24 hours on urine protein electrophoresis (UPEP).
      • Serum free light chain (FLC) assay result with an involved FLC level >=10 mg/dL (>=100 mg/L), provided the serum FLC ratio is abnormal (per IMWG criteria).
    2. A confirmed diagnosis of MM according to IMWG criteria with documented disease progression in need of additional therapy as determined by the investigator.
    3. For Group 2 RRMM doublet arms only: Participants who have received at least 3 prior lines of antimyeloma therapy, including at least 1 proteasome inhibitor (PI), 1 immunomodulatory (IMiD) and 1 anti-CD38 monoclonal antibody (mAb) drug, or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug regardless of the number of prior line(s) of therapy.

    d. For Group 3 RRMM triplet arms only: Participants who have received 1 to 3 prior lines of antimyeloma therapy including at least 1 PI and, 1 IMiD, and who are not refractory to the combination partners.

    e) For anti-CD38 arms, forced expiratory volume in 1 second >=50% by pulmonary function testing.

    f) For carfilzomib arms, baseline echocardiogram with left ventricular ejection fraction >=50%.

  3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening
  4. Has adequate organ function at screening as determined by the laboratory values required for enrollment: Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3) (or >=1*10^9/L); Platelets >=75,000/mm^3 (>=75*10^9/L); Hemoglobin >=8.0 g/dL; estimated creatinine clearance >=30 mL/min (Cockcroft-Gault formula); Total serum bilirubin <=2.0*Upper limit of normal (ULN); an exception for participants with Gilbert's syndrome may be granted after discussion with the sponsor; Liver transaminases (alanine aminotransferase [ALT])/aspartate aminotransferase [AST]) <=3.0*ULN.
  5. Has recovered from adverse reactions to prior myeloma treatment or procedures (example, chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Version 5.0 Grade <=1 or baseline treatment or have the toxicity established as sequela, except for sensory or motor neuropathy, which should have recovered to Grade <=2 or baseline; Grade 1 for bortezomib arm.

Exclusion criteria:

  1. Currently participating in another MM interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) throughout the duration of this study.
  2. Received previous treatment with modakafusp alfa.
  3. Has a diagnosis of primary amyloidosis, Waldenström disease, monoclonal gammopathy of undetermined significance or smoldering MM per IMWG criteria or standard diagnostic criteria, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), lymphoplasmacytic lymphoma.
  4. Has had another malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy and that in the opinion of the local investigator, with concurrence with the principal investigator, is considered cured with minimal risk of recurrence within 3 years.
  5. Has evidence of CNS involvement and/or meningeal involvement due to MM exhibited during screening.
  6. Has a known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the modakafusp alfa formulation or to the study combination agents, the study medications, their analogs, or excipients in the various formulations of any agent per the prescribing information.
  7. Is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and, a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
  8. Has a known history of seropositivity for HIV.
  9. Is seropositive for hepatitis C (anti-hepatitis C virus antibody positive or anti-hepatitis C virus-RNA quantitation positive). Exception: Participants with a sustained virologic response with undetectable HCV RNA level at least 12 weeks after completion of antiviral therapy.
  10. For bortezomib arms: participants received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization.
  11. The participant has a chronic condition requiring the use of systemic corticosteroids >10 mg/dL of prednisone or equivalent, in addition to any required corticosteroids for the treatment of MM.
  12. Has QT interval corrected with Fridericia correction method (QTcF) >480 millisecond (ms) (Grade >=2).

Sites / Locations

  • Hematology And Oncology Mayo Clinic Az, Mayo Clinic College Of Medicine
  • University of California Davis Comprehensive Cancer Center
  • Scripps HealthRecruiting
  • USOR - Rocky Mountain Cancer Centers
  • University Of Colorado At Denver and Health Science Center
  • The University of Iowa Hospitals & ClinicsRecruiting
  • Cancer Center At Greater Baltimore Medical Center
  • Dana Farber Cancer Institute
  • Karmanos Cancer Institute
  • Mayo Clinic
  • Comprehensive Cancer Centers of NevadaRecruiting
  • NYU Langone Hospital - Long IslandRecruiting
  • New York University School of MedicineRecruiting
  • Weill Cornell Medicine/New York Presbyterian HospitalRecruiting
  • Icahn School of Medicine at Mount Sinai
  • Memorial Sloan Kettering Cancer Center - Main Campus
  • Novant Health Cancer InstituteRecruiting
  • Novant Health Cancer Institute - Forsyth Medical CenterRecruiting
  • Gabrail Cancer Center Research
  • Oncology Hematology Care, Inc
  • USOR - Willamette Valley Cancer Institute and Research Center
  • University of Pennsylvania - Abramson Cancer Center
  • Texas Oncology
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Virginia Oncology Associates
  • Universitaetsklinikum St. Poelten
  • Ordensklinikum Linz GmbH Elisabethinen
  • Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
  • CHU UCL Namur site Godinne
  • AZ Delta
  • University Hospitals Leuven
  • Centre Hospitalier Universitaire Sart Tilman
  • University Health Network (UHN) - Princess Margaret Cancer Centre - Myeloma Clinic
  • McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre
  • Soroka University Medical Center (Sumc)
  • Assuta Ashdod Medical Center
  • Rambam Health Care Campus (RHCC) - Meyer Children's Hospital - Pediatric Diabetes & Obesity Clinic
  • Rabin Medical Center, Beilinson Campus
  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
  • IRCCS-Istituto Europeo di Oncologia, Division di Oncoematologia
  • Azienda Ospedaliera Niguarda Ca' Granda
  • Universita degli Studi di Napoli Federico II
  • Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna
  • Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli, UOC Ematologia
  • Catalan Institute of Oncology (ICO) Hospitalet
  • Hospital Universitario de Canarias
  • Hospital De Cabuenes
  • Clinica Universidad de Navarra-Sede Madrid
  • Hospital Universitario Virgen de la Victoria
  • Clinica Universidad de Navarra, Dept of Oncology
  • Hospital Universitario La Fe de Valencia
  • Inselspital Bern
  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
  • Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital
  • Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
  • Hammersmith Hospital - Imperial College Healthcare NHS Trust
  • Northern Centre for Cancer Care,The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide

Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide

Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib

Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib

Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib

Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide

Arm Description

Modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with Lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD [-] negative participants, whichever occurs first. Participants who remain MRD positive with demonstrated clinical benefit after 2 years of maintenance therapy may continue treatment beyond 2 years with agreement of the sponsor/designee.

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. This arm is closed for enrollment after 3 participants were enrolled.

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with Bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Outcomes

Primary Outcome Measures

Number of Participants With Dose-limiting Toxicities (DLTs)
DLT will be defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions; Delay in Cycle 2 by more than 14 days due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities.
Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS is defined as the time from the date on which the first dose of study drug is administered to the date of first documentation of confirmed progression of disease (PD) or death due to any cause, whichever occurs first. PD will be determined by International Myeloma Working Group (IMWG) criteria. PD: increase of >=25 percent (%) from lowest response value in any one or more of the following: serum M-component increase >=0.5 gram per deciliter (g/dL) or urine M-component increase >=200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (>) 10 milligram per deciliter (mg/dL); bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieved a confirmed partial response rate (PR) or better during the study as defined by IMWG Uniform Response Criteria and the response is determined by investigator. PR: >=50% reduction of serum M-protein and >=90% reduction in urine M-protein or less than (<) 200 mg/24 hour, or >=50% decrease in uninvolved FLC or >=50% reduction in plasma cells. At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required.
Duration of Response (DOR)
DOR is defined as the time from the date of first documentation of confirmed PR or better to the date of first documentation of PD or death due to any cause. PR: >=50% reduction of serum M-protein and >=90% reduction in urine M-protein or <200 mg/24 hour, or >=50% decrease in uninvolved FLC or >=50% reduction in plasma cells. At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Groups 2 and 3: Overall Survival (OS)
OS is defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive.
Groups 2 and 3: Time to Progression (TTP)
TTP is defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Groups 2 and 3: Time to Next Treatment (TTNT)
TTNT is defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.
Groups 2 and 3: Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG Uniform Response Criteria. SD is defined as no known evidence of progressive disease or new bone lesions.
Groups 2 and 3: Event-free Survival
EFS is defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD will be determined by International Myeloma Working Group (IMWG) criteria. PD: increase of >=25 % from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be > 10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Groups 2 and 3: Time to Response (TTR)
TTR is defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria.
Group 1: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5
Rate of MRD negativity at a sensitivity of 10^-5 is defined as the percentage of participants who have achieved MRD negative status in participants in the MRD-evaluable analysis set.
Groups 2 and 3: Percentage of Participants with MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator
Rate of MRD negativity CR status a sensitivity of 10^-5 is defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required.
Group 1: Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity
Duration of MRD negativity (10^-5) is defined as the time from the date of first documentation of MRD [-] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurs first. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Group 2 and 3: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5
Rate of MRD negativity at a sensitivity of 10^-5 is defined as the percentage of participants who have achieved MRD negative status.
Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity
Duration of MRD negativity (10^-5) is defined as the time from the date of first documentation of MRD[-] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurs first. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb)

Full Information

First Posted
September 23, 2022
Last Updated
October 12, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT05556616
Brief Title
A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma
Acronym
iinnovate-2
Official Title
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of Intravenous Modakafusp Alfa as Part of Combination Therapy in Adult Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
July 24, 2025 (Anticipated)
Study Completion Date
January 25, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Participants will be given modakafusp alfa through a vein.
Detailed Description
The drug being tested in this study is called modakafusp alfa (TAK-573). The study will evaluate the safety, tolerability and determine the recommended dose of modakafusp alfa in combination with lenalidomide in participants with multiple myeloma (MM), or in combination with pomalidomide, bortezomib, carfilzomib, or daratumumab in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Groups: Group 1: MM Maintenance Therapy, Group 2: RRMM Doublets, Group 3: RRMM Triplets. The study will enroll approximately 18 participants in Group 1, 66 in Group 2, and 36 in Group 3. Participants will be assigned to one of the following treatment groups as given below: Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib Group 3 RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide Group 2 Arm 4 is closed for enrollment. The study will be conducted worldwide. The maximum treatment duration in this study for Group 1 is until disease progression or unacceptable toxicity, or up to 2 years for minimal/measurable residual disease (MRD) negative [-] participants, whichever occurs first. The maximum treatment duration in this study for Group 2 and Group 3 is until disease progression, unacceptable toxicity or until any other discontinuation criterion is met, whichever occurs first. Overall time to participate in the study is approximately up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide
Arm Type
Experimental
Arm Description
Modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with Lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD [-] negative participants, whichever occurs first. Participants who remain MRD positive with demonstrated clinical benefit after 2 years of maintenance therapy may continue treatment beyond 2 years with agreement of the sponsor/designee.
Arm Title
Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide
Arm Type
Experimental
Arm Description
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Arm Title
Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib
Arm Type
Experimental
Arm Description
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Arm Title
Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib
Arm Type
Experimental
Arm Description
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. This arm is closed for enrollment after 3 participants were enrolled.
Arm Title
Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
Arm Type
Experimental
Arm Description
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with Bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Arm Title
Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
Arm Type
Experimental
Arm Description
Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Modakafusp alfa
Other Intervention Name(s)
TAK-573
Intervention Description
Modakafusp alfa intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide capsules orally.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib injection subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
Carfilzomib intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Daratumumab injection subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Pomalidomide capsules orally.
Primary Outcome Measure Information:
Title
Number of Participants With Dose-limiting Toxicities (DLTs)
Description
DLT will be defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions; Delay in Cycle 2 by more than 14 days due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities.
Time Frame
Cycle 1 (Cycle length is 28 days)
Title
Number of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from the date on which the first dose of study drug is administered to the date of first documentation of confirmed progression of disease (PD) or death due to any cause, whichever occurs first. PD will be determined by International Myeloma Working Group (IMWG) criteria. PD: increase of >=25 percent (%) from lowest response value in any one or more of the following: serum M-component increase >=0.5 gram per deciliter (g/dL) or urine M-component increase >=200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (>) 10 milligram per deciliter (mg/dL); bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time Frame
Up to approximately 5 years
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieved a confirmed partial response rate (PR) or better during the study as defined by IMWG Uniform Response Criteria and the response is determined by investigator. PR: >=50% reduction of serum M-protein and >=90% reduction in urine M-protein or less than (<) 200 mg/24 hour, or >=50% decrease in uninvolved FLC or >=50% reduction in plasma cells. At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required.
Time Frame
Up to approximately 5 years
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the date of first documentation of confirmed PR or better to the date of first documentation of PD or death due to any cause. PR: >=50% reduction of serum M-protein and >=90% reduction in urine M-protein or <200 mg/24 hour, or >=50% decrease in uninvolved FLC or >=50% reduction in plasma cells. At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time Frame
Up to approximately 5 years
Title
Groups 2 and 3: Overall Survival (OS)
Description
OS is defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive.
Time Frame
Up to approximately 5 years
Title
Groups 2 and 3: Time to Progression (TTP)
Description
TTP is defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time Frame
Up to approximately 5 years
Title
Groups 2 and 3: Time to Next Treatment (TTNT)
Description
TTNT is defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.
Time Frame
Up to approximately 5 years
Title
Groups 2 and 3: Disease Control Rate (DCR)
Description
DCR is defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG Uniform Response Criteria. SD is defined as no known evidence of progressive disease or new bone lesions.
Time Frame
Up to approximately 5 years
Title
Groups 2 and 3: Event-free Survival
Description
EFS is defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD will be determined by International Myeloma Working Group (IMWG) criteria. PD: increase of >=25 % from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be > 10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time Frame
Up to approximately 5 years
Title
Groups 2 and 3: Time to Response (TTR)
Description
TTR is defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria.
Time Frame
Up to approximately 5 years
Title
Group 1: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5
Description
Rate of MRD negativity at a sensitivity of 10^-5 is defined as the percentage of participants who have achieved MRD negative status in participants in the MRD-evaluable analysis set.
Time Frame
At 6 months, 1 year, and 2 years after the start of treatment.
Title
Groups 2 and 3: Percentage of Participants with MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator
Description
Rate of MRD negativity CR status a sensitivity of 10^-5 is defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required.
Time Frame
Up to approximately 2 years after CR confirmation
Title
Group 1: Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity
Description
Duration of MRD negativity (10^-5) is defined as the time from the date of first documentation of MRD [-] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurs first. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time Frame
Up to approximately 2 years after treatment
Title
Group 2 and 3: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5
Description
Rate of MRD negativity at a sensitivity of 10^-5 is defined as the percentage of participants who have achieved MRD negative status.
Time Frame
Up to approximately 5 years
Title
Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity
Description
Duration of MRD negativity (10^-5) is defined as the time from the date of first documentation of MRD[-] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurs first. PD: increase of >=25% from lowest response value in any one or more of the following: serum M-component increase >=0.5 g/dL or urine M-component increase >=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be >10 mg/dL; bone marrow plasma cell >=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Time Frame
Up to approximately 5 years
Title
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb)
Time Frame
Up to approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Group 1 (MM maintenance: modakafusp alfa/lenalidomide) only must have: MM based on standard IMWG diagnostic criteria. Undergone ASCT for the treatment of MM within 12 months of the start of induction therapy and completed ASCT within 180 days before enrollment- (regardless of the lines of treatment).Consolidation cycles are allowed. Tandem transplant is allowed. Not started lenalidomide maintenance before enrollment. Time to initiation of maintenance therapy: participants may start maintenance therapy as early as 60 days after transplantation and up to 180 days after transplantation or consolidation. MRD positive ( after ASCT (MRD assessed at a threshold of 10^-5 by local SOC methods or central assessment, if a prior local MRD assessment had not been performed). No prior progression after initial therapy (at any time before starting maintenance). Participants whose induction therapy was changed due to suboptimal response or toxicity will be eligible if they do not meet criteria for progression. In addition, no more than 2 regimens will be allowed before ASCT, excluding dexamethasone alone. No prior allogeneic hematopoietic stem cell transplant or solid organ transplant. Recovered to Grade less than or equal to (<=) 1 autologous stem cell transplant (ASCT) -related toxicities from the reversible effects of ASCT (except for alopecia and amenorrhea). ). MM based on standard IMWG diagnostic criteria. Groups 2 and 3 (RRMM doublets and RRMM triplets) must have: Measurable disease, defined as at least 1 of the following: Serum M-protein >=0.5 g/dL (>=5 g/L) on serum protein electrophoresis (SPEP). Urine M-protein >=200 mg/24 hours on urine protein electrophoresis (UPEP). Serum free light chain (FLC) assay result with an involved FLC level >=10 mg/dL (>=100 mg/L), provided the serum FLC ratio is abnormal (per IMWG criteria). A confirmed diagnosis of MM according to IMWG criteria with documented disease progression in need of additional therapy as determined by the investigator. For Group 2 RRMM doublet arms only: Participants who have received at least 3 prior lines of antimyeloma therapy, including at least 1 proteosome inhibitor (PI), 1 immunomodulatory drug (IMiD) and 1 anti-CD38 monoclonal antibody (mAb) drug, or who are triple refractory to a PI, and IMiD, and an anti-CD38 mAb drug regardless of the number of prior line(s) of therapy. d. For Group 3 RRMM triplet arms only: Participants who have received 1 to 3 prior lines of antimyeloma therapy including at least 1 PI and, 1 IMiD, and who are not refractory to the combination partners. e) For anti-CD38 arms, forced expiratory volume in 1second (FEV1) >=50% predicted by pulmonary function testing. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening Has adequate organ function at screening as determined by the laboratory values required for enrollment: Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3) (or >=1*10^9/L); Platelets >=75,000/mm^3 (>=75*10^9/L); Hemoglobin >=8.0 g/dL; estimated creatinine clearance >=30 mL/min (Cockcroft-Gault formula); Total serum bilirubin <=2.0*Upper limit of normal (ULN); an exception for participants with Gilbert's syndrome may be granted after discussion with the sponsor; Liver transaminases (alanine aminotransferase [ALT])/aspartate aminotransferase [AST]) <=3.0*ULN. Has recovered from adverse reactions to prior myeloma treatment or procedures (example, chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Version 5.0 Grade <=1 or baseline treatment or have the toxicity established as sequela, except for sensory or motor neuropathy, which should have recovered to Grade <=2 or baseline; ; (Grade 1 for the bortezomib arm). Exclusion criteria: Currently participating in another MM interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) throughout the duration of this study. Received previous treatment with modakafusp alfa. Has a diagnosis of primary amyloidosis, Waldenström disease, monoclonal gammopathy of undetermined significance or smoldering MM per IMWG criteria or standard diagnostic criteria, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), lymphoplasmacytic lymphoma. Has been diagnosed with another malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy and that in the opinion of the local investigator, with concurrence with the principal investigator, is considered cured with minimal risk of recurrence within 3 years. Has evidence of CNS involvement and/or meningeal involvement due to MM exhibited during screening. Has a known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the modakafusp alfa formulation or to the study combination agents, the study medications, their analogs, or excipients in the various formulations of any agent per the prescribing information. Is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and, a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. Has a known history of seropositivity for HIV. Has a known history of seropositivity for hepatitis C (anti-hepatitis C virus antibody positive or anti-hepatitis C virus-RNA quantitation positive). Exception: Participants with a sustained virologic response with undetectable HCV RNA level at least 12 weeks after completion of antiviral therapy. For bortezomib arms: participants received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization. The participant has a chronic condition requiring the use of systemic corticosteroids >10 mg/dL of prednisone or equivalent, in addition to any required corticosteroids for the treatment of MM. Has a QTcF (QT interval corrected with Fridericia correction method >480 millisecond (ms) (Grade >=2).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Hematology And Oncology Mayo Clinic Az, Mayo Clinic College Of Medicine
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
480-301-4704
Email
bergsagel.leif@mayo.edu
First Name & Middle Initial & Last Name & Degree
Peter Leif Bergsagel
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
916-734-5959
Email
arosenberg@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Aaron Rosenberg
Facility Name
Scripps Health
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
415-476-9000
Email
mahindra.anuj@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Anuj Mahindra
Facility Name
USOR - Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
303-388-4876
Email
robert.rifkin@usoncology.com
First Name & Middle Initial & Last Name & Degree
Robert Rifkin
Facility Name
University Of Colorado At Denver and Health Science Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
peter.forsberg@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Peter Forsberg
Facility Name
The University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
christopher-strouse@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Christopher Strouse
Facility Name
Cancer Center At Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21153
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-632-6140
Email
onadeem7@gmail.com
First Name & Middle Initial & Last Name & Degree
Omar Nadeem
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
313-576-8673
Email
zonderj@karmanos.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Zonder
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
507-238-3828
Email
cook.joselle@mayo.edu
First Name & Middle Initial & Last Name & Degree
Joselle Cook
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
702-952-3400
Email
edwin.kingsley@usoncology.com
First Name & Middle Initial & Last Name & Degree
Edwin Kingsley
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
929-455-2451
Email
faith.davies@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Faith Davies
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
929-455-2451
Email
faith.davies@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Faith Davies
Facility Name
Weill Cornell Medicine/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
run9001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Ruben Niesvizky
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
212-241-6756
Email
larysa.sanchez@mssm.edu
First Name & Middle Initial & Last Name & Degree
Larysa Sanchez
Facility Name
Memorial Sloan Kettering Cancer Center - Main Campus
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novant Health Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
980-302-6600
Email
rthertulien@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Raymond Thertulien
Facility Name
Novant Health Cancer Institute - Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
rthertulien@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Raymond Thertulien
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oncology Hematology Care, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
Kruti.Patel@usoncology.com
First Name & Middle Initial & Last Name & Degree
Kruti Patel
Facility Name
USOR - Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
541-741-3451
Email
chris.yasenchak@usoncology.com
First Name & Middle Initial & Last Name & Degree
Christopher Yasenchak
Facility Name
University of Pennsylvania - Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-615-6508
Email
dan.vogl@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Dan Vogl
Facility Name
Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
214-370-1000
Email
moshe.levy@baylorhealth.edu
First Name & Middle Initial & Last Name & Degree
Moshe Yair Levy
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
713-792-3510
Email
hclee@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Hans Lee
Facility Name
Virginia Oncology Associates
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
celesteann.bremer@usoncology.com
First Name & Middle Initial & Last Name & Degree
Celesteann Bremer
Facility Name
Universitaetsklinikum St. Poelten
City
St. Poelten
State/Province
Saint Poelten
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
petra.pichler@stpoelten.lknoe.at
First Name & Middle Initial & Last Name & Degree
Petra Pichler
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
4373276764411
Email
irene.strassl@ordensklinikum.at
First Name & Middle Initial & Last Name & Degree
Irene Strassl
Facility Name
Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
435725525823
Email
r.greil@salk.at
First Name & Middle Initial & Last Name & Degree
Richard Greil
Facility Name
CHU UCL Namur site Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3281422111
Email
julien.depaus@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Julien Depaus
Facility Name
AZ Delta
City
Roeselare
State/Province
Roeselare West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
dries.deeren@azdelta.be
First Name & Middle Initial & Last Name & Degree
Dries Deeren
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
3216346880
Email
michel.delforge@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Michel Delforge
Facility Name
Centre Hospitalier Universitaire Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+32 43667704
Email
jo.caers@chuliege.be
First Name & Middle Initial & Last Name & Degree
Jo Caers
Facility Name
University Health Network (UHN) - Princess Margaret Cancer Centre - Myeloma Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
4169464501
Email
suzanne.trudel@uhn.ca
First Name & Middle Initial & Last Name & Degree
Suzanne Trudel
Facility Name
McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3JL
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
93419345718
Email
anna.nikonova@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Anna Nikonova
Facility Name
Soroka University Medical Center (Sumc)
City
Be'er Sheva
State/Province
Beer Sheva Negev
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
972544709242
Email
rubio@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Ory Rouvio
Facility Name
Assuta Ashdod Medical Center
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
meravlei@assuta.co.il
First Name & Middle Initial & Last Name & Degree
Merav Leiba
Facility Name
Rambam Health Care Campus (RHCC) - Meyer Children's Hospital - Pediatric Diabetes & Obesity Clinic
City
Haifa
ZIP/Postal Code
31999
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
502061332
Email
n_lavi@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Noa Lavi
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
juliava1@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Julia Vaxman
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
ange.belotti@gmail.com
First Name & Middle Initial & Last Name & Degree
Angelo Belotti
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
claudio.cerchione@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Claudio Cerchione
Facility Name
IRCCS-Istituto Europeo di Oncologia, Division di Oncoematologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
enrico.derenzini@ieo.it
First Name & Middle Initial & Last Name & Degree
Enrico Derenzini
Facility Name
Azienda Ospedaliera Niguarda Ca' Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+39 264442668
Email
annamaria.cafro@ospedaleniguarda.it
First Name & Middle Initial & Last Name & Degree
Anna Maria Cafro
Facility Name
Universita degli Studi di Napoli Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
817462068
Email
fabrizio.pane@unina.it
First Name & Middle Initial & Last Name & Degree
Fabrizio Pane
Facility Name
Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
c.cellini@ausl.ra.it
First Name & Middle Initial & Last Name & Degree
Claudia Cellini
Facility Name
Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli, UOC Ematologia
City
Rome
ZIP/Postal Code
168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
630154968
Email
valerio.destefano@unicatt.it
First Name & Middle Initial & Last Name & Degree
Valerio De Stefano
Facility Name
Catalan Institute of Oncology (ICO) Hospitalet
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
8907
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
935565649
Email
asureda@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Anna Sureda Balari
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz De Tenerife
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
922-678-000
Email
sunillakhwani@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sunil Lakhwani Lakhwani
Facility Name
Hospital De Cabuenes
City
Gijon
ZIP/Postal Code
33394
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
650915409
Email
esthergongar@yahoo.es
First Name & Middle Initial & Last Name & Degree
Maria Esther Gonzalez Garcia
Facility Name
Clinica Universidad de Navarra-Sede Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
948-255-400
Email
paurodriguez@unav.es
First Name & Middle Initial & Last Name & Degree
Paula Rodriguez Otero
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clinica Universidad de Navarra, Dept of Oncology
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
dilara.akhoundovasanoyan@insel.ch
First Name & Middle Initial & Last Name & Degree
Dilara Akhoundova Sanoyan
Facility Name
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
holger.auner@chuv.ch
First Name & Middle Initial & Last Name & Degree
Holger Auner
Facility Name
Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
City
London
State/Province
Greater London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
442078825958
Email
heather.oakervee@nhs.net
First Name & Middle Initial & Last Name & Degree
Heather Oakervee
Facility Name
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
115 9691169
Email
yan.hodgson@nuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Yan Hodgson
Facility Name
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
2071882756
Email
matthew.streetly@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Matthew Streetly
Facility Name
Hammersmith Hospital - Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
7913672624
Email
aristeidis.chaidos@nhs.net
First Name & Middle Initial & Last Name & Degree
Aristeidis Chaidos
Facility Name
Northern Centre for Cancer Care,The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
andrew.charlton1@nhs.net
First Name & Middle Initial & Last Name & Degree
Andrew Charlton

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5dcfb8e4eb634c0f?idFilter=%5B%22TAK-573-1502%22%5D
Description
To obtain more information about this study, click this link.

Learn more about this trial

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma

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