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A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma (iinnovate-1)

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Modakafusp alfa

Dexamethasone

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:

For Parts 1 and 2:

1. Has MM defined by the IMWG criteria with evidence of disease progression and:

In need of additional myeloma therapy as determined by the investigator.
Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug [IMiD], a proteasome inhibitor [PI], an alkylating agent, and/or an anti-CD38 as single agents or in combination).
Is either refractory to or intolerant of at least 1 PI and a least 1 IMiD.

For Part 3:

Has MM defined by the IMWG criteria with evidence of disease progression and:
- In need of additional myeloma therapy as determined by the investigator.
- Has previously received at least 3 lines of myeloma therapy.
- Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide [thalidomide excluded]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and has demonstrated disease progression with the last therapy. Participants who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible.
For participants in Part 2 and 3 only: Measurable disease is defined as :
1. Serum M-protein ≥500 mg/dL (≥5 g/L)
2. Urine M-protein ≥200 mg/24 hours.
3. Serum free light chain (FLC) assay, with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.
During Part 1 only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to [≥ ] 10 percent [%]) and/or plasmacytoma (≥1 centimeter [cm] in diameter) detected by physical examination or imaging.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

Exclusion Criteria:

For Parts 1 and 2:

Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobulinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL).
Who have received autologous stem cell transplant (SCT) 60 days before first infusion of modakafusp alfa or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (≤) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to ≤ Grade 2 or baseline.
Has clinical signs of central nervous system involvement of MM.

For Part 3:

Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 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 [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded.
In addition to the above criteria, participants must not have plasma cell leukemia or have had primary refractory MM, current central nervous system involvement of MM, myelodysplastic syndrome, myeloproliferative syndrome, or have had a second 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.

Sites / Locations

Highlands Oncology Group
Los Angeles Cancer Network - Glendale Adventist Medical Center
University of California Irvine
Office of James R. Berenson MD
Smilow Cancer Hospital at Yale New Haven
Winship Cancer Institute of Emory University
Northwestern Medicine - Northwestern Medical Group
Loyola University Medical Center
Investigative Clinical Research of Indiana, LLC
June E. Nylen Cancer Center
Johns Hopkins Hospital
Boston Medical Center
Dana Farber Cancer InstituteRecruiting
Univeristy of Nebraska Medical CenterRecruiting
USOR - Comprehensive Cancer Centers of Nevada - Central Valley
John Theurer Cancer Center
Montefiore Medical Center
University of Rochester
Levine Cancer CenterRecruiting
Levine Cancer Institute - Concord
Duke University Medical Center
Gabrail Cancer Center
The Ohio State UniversityRecruiting
Oregon Health and Science University
University of PennsylvaniaRecruiting
Baptist Cancer Center - Memphis - Walnut Grove
Lumi Research
British Columbia Cancer Agency Vancouver Centre
Juravinski Cancer Centre
Centre de Recherche du CHUM
Sir Mortimer B. Davis Jewish General Hospital
Peking University People's HospitalRecruiting
Peking University Third HospitalRecruiting
Sun Yat-Sen University Cancer CenterRecruiting
Henan Cancer HospitalRecruiting
Wuhan Union HospitalRecruiting
Zhongnan Hospital of Wuhan UniversityRecruiting
Nanjing Drum Tower HospitalRecruiting
The First Affiliated Hospital of Soochow University - Suzhou First People's HospitalRecruiting
Shanghai Fourth People's HospitalRecruiting
Tianjin Medical University Cancer Institute & HospitalRecruiting
The First Affiliated Hospital, Zhejiang UniversityRecruiting
Institut de cancerologie Strasbourg Europe
Centre Hospitalier Universitaire Henri Mondor
Hopital Saint-Antoine
Hopital Necker-Enfants Malades
Centre Hospitalier Universitaire de Toulouse Hopital Purpan
Hopital Saint-Vincent de Paul - Lille
Centre Hospitalier Regional Universitaire de Lille
Centre Hospitalier Universitaire Nantes - Hotel Dieu
Centre Hospitalier Universitaire de Poitiers
Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy
Universitatsklinik Tubingen
Universitatsklinikum Leipzig
Evaggelismos General Hospital
Alexandra General Hospital of Athens
University Regional General Hospital of Patras
The Chaim Sheba Medical Center
Hadassah Medical Center
Tel Aviv Sourasky Medical Center
AON SS Antonio e Biagio e Cesare Arrigo
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Fondazione IRCCS Policlinico San Matteo
Nagoya City University HospitalRecruiting
Ogaki Municipal HospitalRecruiting
University Hospital Kyoto Prefectural University of MedicineRecruiting
National Hospital Organization Okayama Medical CenterRecruiting
Japanese Red Cross Medical CenterRecruiting
Chonnam National University Hwasun Hospital
Seoul National University Hospital
The Catholic University of Korea - Seoul St. Mary's Hospital
Oslo Universitetssykehus-Ulleval Hospital
Ad-Vance Medical Research
Hospital Espanol Auxilio Mutuo
Hospital Universitari Germans Trias i Pujol
Hospital Universitari Vall d'Hebron
Hospital Clinic de Barcelona
Hospital Universitario 12 de Octubre
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario de Salamanca
Hospital Universitario Marques de Valdecilla
Tri-Service General Hospital
National Taiwan University Hospital
Ankara Universitesi
Ondokuz Mayis Universitesi Tp Fakultesi
University Hospitals Birmingham NHS Foundation Trust
Royal Cornwall Hospital NHS Trust
University College London Hospitals NHS Foundation Trust
Genesis Care - Milton Keynes
Oxford University Hospitals NHS Foundation Trust
The Royal Marsden NHS Foundation Trust
Genesis Care Windsor - Genesis Care UK Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg

Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD

Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD

Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD

Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg

Part 3 (Dose Extension): Modakafusp alfa 120 mg

Part 3 (Dose Extension): Modakafusp alfa 240 mg

Arm Description

Modakafusp alfa 0.001 up to 14 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Modakafusp alfa TBD, infusion, IV, once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Modakafusp alfa TBD, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Modakafusp alfa TBD, infusion, IV, once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Dose(s) for Phase 2 will be based on safety and tolerability results from the preceding Phase 1 dose escalation cohorts. Participants in Phase 2 cohorts will receive modakafusp alfa TBD as a single agent. Participants in at least 1 cohort will receive modakafusp alfa TBD and modakafusp alfa TBD and dexamethasone 40 mg, orally, once weekly of each 28-day treatment cycle until treatment discontinuation.

Participants will receive modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Participants will receive modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Outcomes

Primary Outcome Measures

Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

Part 1: Percentage of Participants With Dose-limiting Toxicities (DLTs)

DLTs will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle will be considered DLTs.

Part 1: Percentage of Participants Reporting one or More Grade 3 TEAEs

TEAEs Grades will be evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.

Part 1: Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)

An SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.

Part 1: Percentage of Participants Who Discontinue the Treatment Because of TEAE

A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

Part 1: Percentage of Participants With Dose Modifications: Dose Delay

Part 1: Percentage of Participants With Dose Modifications: Dose Interruptions

Part 1: Percentage of Participants With Dose Modifications: Dose Reductions

Part 1: Percentage of Participants With Clinically Significant Laboratory Values

Laboratory values will include hematology, chemistry, and urine analysis.

Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements

Vital signs will include temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.

Part 2: Overall Response Rate (ORR)

ORR is defined as the percentage of participants who achieved a partial response rate (PR) or better during the study as defined by International Myeloma Working Group (IMWG) Uniform Response Criteria.

Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)

ORR is defined as the percentage of participants who achieved a PR or better during the study as defined by IMWG Uniform Response Criteria assessed by IRC.

Secondary Outcome Measures

Part 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events

Percentage of participants with TEAEs meeting DLT definition that occur after phase (P) 1 Cycle (C) 1 will be reported. Toxicity will be evaluated as per the NCI CTCAE, Version 5.0. The hematologic TEAEs of Grade ≥3 clearly unrelated to the underlying disease and occur during the first cycle that is considered DLTs: Grade ≥3 hemolysis; Grade 4 neutropenia for >7 consecutive days; Grade 4 thrombocytopenia for >14 consecutive days; Grade 3 thrombocytopenia with clinically significant bleeding; Any other Grade ≥4 hematologic toxicity except for Grade 4 lymphopenia. An incomplete recovery from treatment-related toxicity causing >2-week delay in the next scheduled infusion before the initiation of C2 will be considered a DLT. Frequencies and other TEAEs occur over the course of extended treatment with study drug, including dose modification, treatment discontinuation, and clinically significant laboratory values and vital signs.

Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa

PK blood samples will be collected at the following time points for schedule A: Pre-infusion and at multiple time points (up to 72 hour [h]) C1-2 D1, 15; up to 4h C1-2 D8, 22 and C2 D15; up to 24h C3 D1; up to 4h on C3, 4-6 D15, D1, C4-6 and C7-13 D1; Schedule B: Pre-infusion and at multiple time points (up to 24h) on C1-2 D1, 15; up to 24h C3 D1; up to 4h C3 D15 and C4-13 D1; Schedule C: Pre-infusion and at multiple time points (up to 336h) on C1-2 D1; up to 4h on C3-17 D1; Schedule D: Pre-infusion and at multiple time points (up to 504h) C1-2 D1; up to 4h C3-13 D1 post-infusion (Schedule A, B and D cycle is 28 days and schedule C cycle is 21 days).

Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa

Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa

Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa

Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa

Part 1: T1/2: Terminal Elimination Half-life for Modakafusp alfa

Part 1: CL: Clearance for Modakafusp alfa

Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa

Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibodies (ADA)

Part 1: Objective Response Rate (ORR)

ORR is defined as the percentage of participants who achieved a PR or better during the study as defined by IMWG Uniform Response Criteria.

Parts 1 and 2: Clinical Benefit Rate (CBR)

CBR is defined as the percentage of participants who achieved MR or better during the study as defined by IMWG Uniform Response Criteria.

Parts 1 and 2: Disease Control Rate (DCR)

DCR is defined as the percentage of participants who achieved a stable disease (SD) or better during the study as defined by IMWG Uniform Response Criteria.

Parts 1, 2 and 3: Duration of Response (DOR)

DOR is defined as the time from the date of first documentation of response PR or better to the time of disease progression or death, whichever occurs first.

Parts 1 and 2: Time to Response

Time to response is defined as the time from first dose to the date of first documentation of response (PR or better).

Parts 1, 2 and 3: Progression Free Survival (PFS)

PFS is defined as the time from the date of enrollment until the date of PD or death due to any cause, whichever occurs first as defined by IMWG Criteria.

Parts 2 and 3: Overall Survival (OS)

Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa

Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa

Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa

Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa

Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa

Part 2: CL: Clearance for Modakafusp alfa

Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa

Part 2: T1/2z: Terminal Elimination Half-life for Modakafusp alfa

Part 3: Objective Response Rate (ORR) by Investigator Assessment

ORR is defined as the percentage of participants who achieved a PR or better during the study as defined by IMWG Uniform Response Criteria assessed by investigators.

Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment

CBR is defined as the percentage of participants who achieved MR or better during the study as defined by IMWG Uniform Response Criteria.

Part 3: Duration of Clinical Benefit

Duration of clinical benefit is defined as the time from first documented evidence of confirmed MR or better until the earliest date of a confirmed PD per IMWG, or death among patients who achieve a confirmed MR or better.

Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment

DCR is defined as the percentage of participants who achieved a stable disease (SD) or better during the study as defined by IMWG Uniform Response Criteria.

Part 3: Duration of Disease Control

Duration of disease control is defined as the time from first documented evidence of SD or better until the earliest date of a confirmed PD per IMWG, or death among patients who achieve a SD or better.

Part 3: Time to Progression (TTP) by IRC and Investigator Assessment

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.

Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

MRD negativity at a sensitivity of 10^-5 is defined as patients who are MRD negative at a sensitivity of 10^-5 in patients achieving suspected complete response (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.

Part 3:Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

Duration of MRD negativity (10^-5) is defined as the time from the first MRD negative status (10^-5) to the earliest date of the MRD positive status (10^-5), confirmed PD per IMWG or death.

Part 3: Percentage of Participants With Adverse Events (AEs)

Part 3: Percentage of Participants With Serious Adverse Events (SAEs)

Part 3: Percentage of Participants With Clinically Significant Laboratory Values

Laboratory values will include hematology, chemistry, and urine analysis.

Part 3: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Status

ECOG is a grade, where grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed <50% of the time. Grade 3: In bed >50% of the time. Grade 4: 100% bedridden. Grade 5: Dead.

Part 3: Health Care Utilization: Length of Hospital Stays

Part 3: Percentage of Participants With Neutralizing Antibodies (NAb)

Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter

Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits.

Part 3: Patient-reported Outcome (PRO): Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)

The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image and future perspective), and 2 symptoms scales (disease symptoms and side effects of treatment). The QLQ-MY20 raw scores are converted into scale scores ranging from 0 to 100. For the symptom scales, lower scores represent better functioning. All items in this questionnaire have a recall period of 1 week.

Full Information

NCT ID

NCT03215030

First Posted

July 11, 2017

Last Updated

September 20, 2023

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT03215030

Brief Title

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

Acronym

iinnovate-1

Official Title

A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 4, 2017 (Actual)

Primary Completion Date

March 19, 2024 (Anticipated)

Study Completion Date

September 3, 2024 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. 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. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

Detailed Description

The drug being tested in this study, and which will be given through a vein, is called modakafusp alfa (TAK-573 ) as single agent or in combination with dexamethasone. The study will determine the safety, tolerability, and efficacy of modakafusp alfa as single agent and in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Parts: Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Dose Extension The study will enroll approximately 65 participants in Part 1, 35 in Part 2, and 236 in Part 3. Participants will be assigned to one of the following treatment groups in Parts 1 and 2 of the study. Participants will be randomly assigned in Part 3 of the study as given below: Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD

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, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD

Arm Type

Experimental

Arm Description

Arm Title

Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD

Arm Type

Experimental

Arm Description

Arm Title

Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD

Arm Type

Experimental

Arm Description

Arm Title

Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg

Arm Type

Experimental

Arm Description

Arm Title

Part 3 (Dose Extension): Modakafusp alfa 120 mg

Arm Type

Experimental

Arm Description

Participants will receive modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Arm Title

Part 3 (Dose Extension): Modakafusp alfa 240 mg

Arm Type

Experimental

Arm Description

Participants will receive modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Intervention Type

Drug

Intervention Name(s)

Modakafusp alfa

Other Intervention Name(s)

TAK-573, TEV-48573

Intervention Description

Modakafusp alfa intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone.

Primary Outcome Measure Information:

Title

Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants With Dose-limiting Toxicities (DLTs)

Description

Time Frame

Up to Cycle 1 (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)

Title

Part 1: Percentage of Participants Reporting one or More Grade 3 TEAEs

Description

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)

Description

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants Who Discontinue the Treatment Because of TEAE

Description

A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants With Dose Modifications: Dose Delay

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants With Dose Modifications: Dose Interruptions

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants With Dose Modifications: Dose Reductions

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants With Clinically Significant Laboratory Values

Description

Laboratory values will include hematology, chemistry, and urine analysis.

Time Frame

Up to approximately 90 months

Title

Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements

Description

Vital signs will include temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.

Time Frame

Up to approximately 90 months

Title

Part 2: Overall Response Rate (ORR)

Description

Time Frame

Up to approximately 90 months

Title

Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)

Description

ORR is defined as the percentage of participants who achieved a PR or better during the study as defined by IMWG Uniform Response Criteria assessed by IRC.

Time Frame

Up to approximately 90 months

Secondary Outcome Measure Information:

Title

Part 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events

Description

Time Frame

Up to approximately 90 months

Title

Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa

Description

Time Frame

Schedule A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)

Title

Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa

Description

Time Frame

Title

Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa

Description

Time Frame

Title

Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa

Description

Time Frame

A Cycle(C)1-13,Day(D)1,8,15,22; Schedule B C1-13,D1,15; Schedule C C1-17,D1; Schedule D C1-13,D1: Pre-infusion and at multiple times post-infusion (cycle length is 28 days for Schedule A, B and D; 21 days for Schedule C)

Title

Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa

Description

Time Frame

Title

Part 1: T1/2: Terminal Elimination Half-life for Modakafusp alfa

Description

Time Frame

Title

Part 1: CL: Clearance for Modakafusp alfa

Description

Time Frame

Title

Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa

Description

Time Frame

Title

Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibodies (ADA)

Time Frame

Up to approximately 90 months

Title

Part 1: Objective Response Rate (ORR)

Description

ORR is defined as the percentage of participants who achieved a PR or better during the study as defined by IMWG Uniform Response Criteria.

Time Frame

Up to approximately 90 months

Title

Parts 1 and 2: Clinical Benefit Rate (CBR)

Description

CBR is defined as the percentage of participants who achieved MR or better during the study as defined by IMWG Uniform Response Criteria.

Time Frame

Up to approximately 90 months

Title

Parts 1 and 2: Disease Control Rate (DCR)

Description

DCR is defined as the percentage of participants who achieved a stable disease (SD) or better during the study as defined by IMWG Uniform Response Criteria.

Time Frame

Up to approximately 90 months

Title

Parts 1, 2 and 3: Duration of Response (DOR)

Description

DOR is defined as the time from the date of first documentation of response PR or better to the time of disease progression or death, whichever occurs first.

Time Frame

Up to approximately 90 months

Title

Parts 1 and 2: Time to Response

Description

Time to response is defined as the time from first dose to the date of first documentation of response (PR or better).

Time Frame

Up to approximately 90 months

Title

Parts 1, 2 and 3: Progression Free Survival (PFS)

Description

PFS is defined as the time from the date of enrollment until the date of PD or death due to any cause, whichever occurs first as defined by IMWG Criteria.

Time Frame

Up to approximately 90 months

Title

Parts 2 and 3: Overall Survival (OS)

Time Frame

Up to approximately 90 months

Title

Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 2: CL: Clearance for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 2: T1/2z: Terminal Elimination Half-life for Modakafusp alfa

Time Frame

Up to approximately 90 months

Title

Part 3: Objective Response Rate (ORR) by Investigator Assessment

Description

ORR is defined as the percentage of participants who achieved a PR or better during the study as defined by IMWG Uniform Response Criteria assessed by investigators.

Time Frame

Up to approximately 90 months

Title

Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment

Description

CBR is defined as the percentage of participants who achieved MR or better during the study as defined by IMWG Uniform Response Criteria.

Time Frame

Up to approximately 90 months

Title

Part 3: Duration of Clinical Benefit

Description

Time Frame

Up to approximately 90 months

Title

Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment

Description

DCR is defined as the percentage of participants who achieved a stable disease (SD) or better during the study as defined by IMWG Uniform Response Criteria.

Time Frame

Up to approximately 90 months

Title

Part 3: Duration of Disease Control

Description

Time Frame

Up to approximately 90 months

Title

Part 3: Time to Progression (TTP) by IRC and Investigator Assessment

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.

Time Frame

Up to approximately 90 months

Title

Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

Description

Time Frame

Up to approximately 90 months

Title

Part 3:Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

Description

Duration of MRD negativity (10^-5) is defined as the time from the first MRD negative status (10^-5) to the earliest date of the MRD positive status (10^-5), confirmed PD per IMWG or death.

Time Frame

Up to approximately 90 months

Title

Part 3: Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

Up to approximately 90 months

Title

Part 3: Percentage of Participants With Serious Adverse Events (SAEs)

Description

Time Frame

Up to approximately 90 months

Title

Part 3: Percentage of Participants With Clinically Significant Laboratory Values

Description

Laboratory values will include hematology, chemistry, and urine analysis.

Time Frame

Up to approximately 90 months

Title

Part 3: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Status

Description

ECOG is a grade, where grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed <50% of the time. Grade 3: In bed >50% of the time. Grade 4: 100% bedridden. Grade 5: Dead.

Time Frame

Up to approximately 90 months

Title

Part 3: Health Care Utilization: Length of Hospital Stays

Time Frame

Up to approximately 90 months

Title

Part 3: Percentage of Participants With Neutralizing Antibodies (NAb)

Time Frame

Up to approximately 90 months

Title

Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter

Description

Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits.

Time Frame

Up to approximately 90 months

Title

Part 3: Patient-reported Outcome (PRO): Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)

Description

Time Frame

Up to approximately 90 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For Parts 1 and 2: 1. Has MM defined by the IMWG criteria with evidence of disease progression and: In need of additional myeloma therapy as determined by the investigator. Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug [IMiD], a proteasome inhibitor [PI], an alkylating agent, and/or an anti-CD38 as single agents or in combination). Is either refractory to or intolerant of at least 1 PI and a least 1 IMiD. For Part 3: Has MM defined by the IMWG criteria with evidence of disease progression and: In need of additional myeloma therapy as determined by the investigator. Has previously received at least 3 lines of myeloma therapy. Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide [thalidomide excluded]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and has demonstrated disease progression with the last therapy. Participants who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible. For participants in Part 2 and 3 only: Measurable disease is defined as : Serum M-protein ≥500 mg/dL (≥5 g/L) Urine M-protein ≥200 mg/24 hours. Serum free light chain (FLC) assay, with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal. During Part 1 only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to [≥ ] 10 percent [%]) and/or plasmacytoma (≥1 centimeter [cm] in diameter) detected by physical examination or imaging. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. Exclusion Criteria: For Parts 1 and 2: Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobulinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL). Who have received autologous stem cell transplant (SCT) 60 days before first infusion of modakafusp alfa or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression. Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (≤) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to ≤ Grade 2 or baseline. Has clinical signs of central nervous system involvement of MM. For Part 3: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 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 [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded. In addition to the above criteria, participants must not have plasma cell leukemia or have had primary refractory MM, current central nervous system involvement of MM, myelodysplastic syndrome, myeloproliferative syndrome, or have had a second 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Takeda Contact

Phone

+1-877-825-3327

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

Highlands Oncology Group

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Los Angeles Cancer Network - Glendale Adventist Medical Center

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of California Irvine

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Office of James R. Berenson MD

City

West Hollywood

State/Province

California

ZIP/Postal Code

90069

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Smilow Cancer Hospital at Yale New Haven

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Winship Cancer Institute of Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Northwestern Medicine - Northwestern Medical Group

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Investigative Clinical Research of Indiana, LLC

City

Noblesville

State/Province

Indiana

ZIP/Postal Code

46062

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

June E. Nylen Cancer Center

City

Sioux City

State/Province

Iowa

ZIP/Postal Code

51101

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

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

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

617-632-4952

omar_nadeem@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Omar Nadeem

Facility Name

Univeristy of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

402-559-8500

sarah.holstein@unmc.edu

First Name & Middle Initial & Last Name & Degree

Sarah Holstein

Facility Name

USOR - Comprehensive Cancer Centers of Nevada - Central Valley

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

John Theurer Cancer Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14627

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Levine Cancer Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28402

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

704-774-9322

shebli.atrash@atriumhealth.org

First Name & Middle Initial & Last Name & Degree

Shebli Atrash

Facility Name

Levine Cancer Institute - Concord

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28205

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Gabrail Cancer Center

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

614-293-7638

srinivas.devarakonda@osumc.edu

First Name & Middle Initial & Last Name & Degree

Srinivas Devarakonda

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

215-615-6508

dan.vogl@uphs.upenn.edu

First Name & Middle Initial & Last Name & Degree

Dan Vogl

Facility Name

Baptist Cancer Center - Memphis - Walnut Grove

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Lumi Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77002

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

British Columbia Cancer Agency Vancouver Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Centre de Recherche du CHUM

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Sir Mortimer B. Davis Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Peking University People's Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8613311491805

jin1lu@sina.com

First Name & Middle Initial & Last Name & Degree

Jin Lu

Facility Name

Peking University Third Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100089

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+861068964010

jinghm@yahoo.com

First Name & Middle Initial & Last Name & Degree

Hongmei Jing

Facility Name

Sun Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8613602713223

xiazhj@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Zhongjun Xia

Facility Name

Henan Cancer Hospital

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8613526607830

fdation@126.com

First Name & Middle Initial & Last Name & Degree

Baijun Fang

Facility Name

Wuhan Union Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430023

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8615342346782

suncy0618@163.com

First Name & Middle Initial & Last Name & Degree

Chunyan Sun

Facility Name

Zhongnan Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8602767812888

zhoufuling@163.com

First Name & Middle Initial & Last Name & Degree

Fuling Zhou

Facility Name

Nanjing Drum Tower Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+862583105860

chenbinggcp@163.com

First Name & Middle Initial & Last Name & Degree

Bing Chen

Facility Name

The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8613962191404

fuzhengzheng@suda.edu.cn

First Name & Middle Initial & Last Name & Degree

Zhenzhen Fu

Facility Name

Shanghai Fourth People's Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+863816052522

fu_weijunhospital@126.com

First Name & Middle Initial & Last Name & Degree

Weijun Fu

Facility Name

Tianjin Medical University Cancer Institute & Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8618622221250

tzxyklcsy@163.com

First Name & Middle Initial & Last Name & Degree

Yefei Wang

Facility Name

The First Affiliated Hospital, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+8613857190311

czclinicaltrial@163.com

First Name & Middle Initial & Last Name & Degree

Zhen Cai

Facility Name

Institut de cancerologie Strasbourg Europe

City

Strasbourg

State/Province

Alsace

ZIP/Postal Code

67200

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier Universitaire Henri Mondor

City

Creteil Cedex

State/Province

Ile-de-france

ZIP/Postal Code

91010

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Hopital Saint-Antoine

City

Paris Cedex 12

State/Province

Ile-de-france

ZIP/Postal Code

75012

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Hopital Necker-Enfants Malades

City

Paris

State/Province

Ile-de-france

ZIP/Postal Code

75015

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier Universitaire de Toulouse Hopital Purpan

City

Toulouse

State/Province

Midi-pyrenees

ZIP/Postal Code

31059

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Hopital Saint-Vincent de Paul - Lille

City

Lille Cedex

State/Province

NORD Pas-de-calais

ZIP/Postal Code

59020

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier Regional Universitaire de Lille

City

Lille Cedex

State/Province

NORD Pas-de-calais

ZIP/Postal Code

59037

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier Universitaire Nantes - Hotel Dieu

City

Nantes Cedex 1

State/Province

PAYS DE LA Loire

ZIP/Postal Code

44093

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier Universitaire de Poitiers

City

Poitiers

State/Province

Poitou-charentes

ZIP/Postal Code

86000

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy

City

Argenteuil Cedex

ZIP/Postal Code

95107

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Universitatsklinik Tubingen

City

Tuebingen

State/Province

Baden-wuerttemberg

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Universitatsklinikum Leipzig

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Evaggelismos General Hospital

City

Athens

State/Province

Attica

ZIP/Postal Code

10676

Country

Greece

Individual Site Status

Active, not recruiting

Facility Name

Alexandra General Hospital of Athens

City

Athens

State/Province

Attica

ZIP/Postal Code

11528

Country

Greece

Individual Site Status

Active, not recruiting

Facility Name

University Regional General Hospital of Patras

City

Patra

State/Province

Peloponnese

ZIP/Postal Code

26504

Country

Greece

Individual Site Status

Active, not recruiting

Facility Name

The Chaim Sheba Medical Center

City

Ramat Gan

State/Province

Tel Aviv

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

AON SS Antonio e Biagio e Cesare Arrigo

City

Alessandria

ZIP/Postal Code

15121

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

City

Catania

ZIP/Postal Code

95125

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Fondazione IRCCS Policlinico San Matteo

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Nagoya City University Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

467-8601

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+81528515511

iida@med.nagoya-cu.ac.jp

First Name & Middle Initial & Last Name & Degree

Shinsuke Iida

Facility Name

Ogaki Municipal Hospital

City

Gifu-shi

State/Province

Gifu

ZIP/Postal Code

503-8502

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+81 584-81-3341

h-kosugi@umin.ac.jp

First Name & Middle Initial & Last Name & Degree

Hiroshi Kosugi

Facility Name

University Hospital Kyoto Prefectural University of Medicine

City

Kyoto-City

State/Province

Kyoto

ZIP/Postal Code

602-855

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

Phone

81752515740

junkuro@koto.kpu-m.ac.jp

First Name & Middle Initial & Last Name & Degree

Junya Kuroda

Facility Name

National Hospital Organization Okayama Medical Center

City

Okayama-city

State/Province

Okayama

ZIP/Postal Code

701-1192

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+81862949911

kazusuna@pop12.odn.ne.jp

First Name & Middle Initial & Last Name & Degree

Kazutaka Sunami

Facility Name

Japanese Red Cross Medical Center

City

Tokyo

ZIP/Postal Code

150-8935

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+81 3-3400-1311

i.s.h.i.28@rondo.ocn.ne.jp

First Name & Middle Initial & Last Name & Degree

Tadao Ishida

Facility Name

Chonnam National University Hwasun Hospital

City

Hwasun

State/Province

Jeollanam-do

ZIP/Postal Code

58128

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

The Catholic University of Korea - Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Oslo Universitetssykehus-Ulleval Hospital

City

Oslo

ZIP/Postal Code

0450

Country

Norway

Individual Site Status

Active, not recruiting

Facility Name

Ad-Vance Medical Research

City

Ponce

ZIP/Postal Code

00730

Country

Puerto Rico

Individual Site Status

Active, not recruiting

Facility Name

Hospital Espanol Auxilio Mutuo

City

San Juan

ZIP/Postal Code

00919

Country

Puerto Rico

Individual Site Status

Active, not recruiting

Facility Name

Hospital Universitari Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Hospital Universitario Virgen de la Arrixaca

City

Murcia

ZIP/Postal Code

30120

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Hospital Universitario de Salamanca

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Hospital Universitario Marques de Valdecilla

City

Santander

ZIP/Postal Code

39008

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Tri-Service General Hospital

City

Taipei

State/Province

Taipei CITY

ZIP/Postal Code

11490

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Ankara Universitesi

City

Yenimahalle

State/Province

Ankara

ZIP/Postal Code

06560

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Ondokuz Mayis Universitesi Tp Fakultesi

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

University Hospitals Birmingham NHS Foundation Trust

City

Birmingham

State/Province

England

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Royal Cornwall Hospital NHS Trust

City

Cornwell

State/Province

England

ZIP/Postal Code

TR1 3LI

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

University College London Hospitals NHS Foundation Trust

City

London

State/Province

England

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Genesis Care - Milton Keynes

City

Milton Keynes

State/Province

England

ZIP/Postal Code

MK14 6LS

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Oxford University Hospitals NHS Foundation Trust

City

Oxford

State/Province

England

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

The Royal Marsden NHS Foundation Trust

City

Sutton

State/Province

England

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Genesis Care Windsor - Genesis Care UK Ltd.

City

Windsor

State/Province

England

ZIP/Postal Code

SL43HD

Country

United Kingdom

Individual Site Status

Active, not recruiting

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/5f6b603b4db2bf003ab4a2ed?idFilter=%5B%22TAK-573-1501%22%5D

Description

To obtain more information about this study, click this link.

Learn more about this trial

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

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