Back to results

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma (iinnovate-3)

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Modakafusp Alfa

Daratumumab

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:

Documented multiple myeloma (MM) diagnosis per IMWG criteria.
Measurable disease, defined as at least 1 of the following:
1. Serum M protein ≥0.5 grams per deciliter [g/dL] (≥5 g/L) on serum protein electrophoresis (SPEP).
2. Urine M protein ≥200 mg/24 hours on urine protein electrophoresis (UPEP).
3. Serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.
For participants in the Phase 1 Dose Escalation only:
Must have received at least 3 prior lines of therapy, including at least 1 proteosome inhibitor (PI), 1 immunomodulatory imide drug (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) or therapy.
For participants in Phase 2a Dose Finding only:
1. Received 1 to 3 prior line(s) of antimyeloma therapy.
2. Must be refractory to prior lenalidomide treatment.
3. Participants must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment.
4. Documented progressive disease on or after the last regimen.
5. Participants must have PR or better to at least 1 line of prior therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.

Exclusion Criteria:

Prior exposure to modakafusp alfa.
Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma.
Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE, Version 5 Grade ≤1 or baseline, except for alopecia.
Previous allogeneic stem cell transplant at any time or autologous stem cell transplant (ASCT) within 12 weeks of planned start of dosing.
Seropositive for hepatitis B, or known history of seropositivity for hepatitis C or of seropositivity for human immunodeficiency virus (HIV).
Participant has congestive heart failure (New York Heart Association Grade ≥II), cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension.
Participant has QT interval corrected by the Fridericia method >480 milliseconds [msec] (Grade ≥2).
Participant has a chronic condition that will require the chronic use of systemic corticosteroids >10 milligrams per day (mg/d) of prednisone or equivalent on top of any required corticosteroids for multiple myeloma (MM).

Sites / Locations

Banner MD Anderson Cancer CenterRecruiting
Cedars-Sinai Medical CenterRecruiting
James R Berenson, MD Inc.
Fort Wayne Medical Oncology and Hematology, IncRecruiting
HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)Recruiting
Tulane University Health Sciences CenterRecruiting
Floating Hospital for Children at Tufts Medical CenterRecruiting
Washington University School of MedicineRecruiting
University of Nebraska Medical CenterRecruiting
Summit Medical Group PARecruiting
New York Cancer and Blood SpecialistsRecruiting
Stony Brook University HospitalRecruiting
University of Cincinnati - Vontz Center for Molecular StudiesRecruiting
Tranquil Clinical ResearchRecruiting
University of Wisconsin Hospitals and Clinics
Concord Repatriation General HospitalRecruiting
The Alfred HospitalRecruiting
William Osler Health Center
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital FleurimontRecruiting
Sun Yat-Sen University Cancer CenterRecruiting
Wuhan Union HospitalRecruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
Zhejiang University School of Medicine - The First Affiliated Hospital (Zhejiang Provincial First Hospital)
Fakultni nemocnice Olomouc
Vseobecna Fakultni Nemocnice v Praze
FNsP Ostrava
CHRU LilleRecruiting
Institut Paoli-CalmettesRecruiting
Klinikum Nuernberg Nord
Universitaetsklinikum Koeln
Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
Semmelweis University
Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet
Chonnam National University Hwasun HospitalRecruiting
Samsung Medical CenterRecruiting
The Catholic University of Korea, Seoul St. Marys HospitalRecruiting
Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc.
Hospital Universitario Vall d'HebronRecruiting
Fundacion Instituto de Estudios Ciencias de la Salud de Castilla y Leon-Investigacion Biomedica de Salamanca (IBSAL)Recruiting
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
University Hospitals of Derby and Burton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Phase 1 Dose Escalation

Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab

Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab

Arm Description

Modakafusp alfa 60 to 240 mg, infusion, intravenously, once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Modakafusp alfa at dose level 1 (DL1) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Modakafusp alfa at dose level 2 (DL2) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Outcomes

Primary Outcome Measures

Phase 1: Number of Participants with Dose Limiting Toxicities (DLT)

DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Phase 1: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Per Severity

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs will be evaluated as per the NCI CTCAE Version 5.0.

Phase 2a: Overall Response Rate (ORR)

ORR is defined as the percentage of participants who achieve a confirmed partial response (PR) or better during the study in the safety population. ORR will be assessed by the investigator per International Myeloma Working Group (IMWG) criteria.

Secondary Outcome Measures

Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa

Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa

Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa

Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration

Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa

Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa

Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa

Phase 1: Volume of Distribution at Steady State After Intravenous Administration for Modakafusp Alfa

Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab

Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab

Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab

Phase 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Daratumumab

Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for Daratumumab

Phase 1: Overall Response Rate (ORR)

ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria.

Phase 1 and Phase 2a: Duration of Response (DOR)

DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DOR will be calculated for confirmed responders only (PR or better). DOR will be assessed by the investigator as per IMWG criteria.

Phase 1 and Phase 2a: Progression Free Survival (PFS)

PFS is defined as the time from the date of the first dose administration of any study drug to the first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. PFS will be assessed by the investigator as per IMWG criteria.

Phase 1 and Phase 2a: Overall Survival (OS)

OS is defined as the time from the date of the first dose administration of any study drug to the documentation of death due to any cause. OS will be assessed by the investigator as per IMWG criteria.

Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies

Phase 1 and Phase 2a: Titer of Anti-drug Antibodies

Phase 1 and Phase 2a: Number of Participants With Neutralizing Antibodies (NAb) Against Study Drug

Phase 1 and Phase 2a: Rate of Measurable [Minimal] Residual Disease Negative (MRD[-]) Complete Response (CR)

MRD[-] CR rate is defined as the percentage of participants who achieve confirmed CR assessed by the investigator and MRD[-] status using a threshold of 10^-5. The analysis will be based on the response-evaluable population.

Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity

Duration of MRD negativity for participants achieving MRD negativity is defined as the time from the date of first documentation of MRD negativity to the first documentation of MRD positivity or confirmed progressive disease, whichever occurs first. It will be calculated for participants achieving MRD negativity only.

Phase 2a: Clinical Benefit Rate (CBR)

CBR is defined as the percentage of participants who had a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response based on investigators' disease assessment per IMWG criteria.

Phase 2a: Duration of Clinical Benefit (DCB)

DCB is defined as the time from the date of first documentation of a minimal response or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DCB will be calculated for only participants who achieved a minimal response or better. DCB will be assessed by the investigator as per IMWG criteria.

Phase 2a: Disease Control Rate (DCR)

DCR is defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, minimal response, or stable disease (SD) based on investigators' disease assessment per IMWG criteria.

Phase 2a: Duration of Disease Control

Duration of disease control is defined as the time from date of first documentation of SD or better to the date of first documentation of confirmed progressive disease or death due to any cause. Duration of disease control will be calculated for only patients who achieved SD or better. It will be assessed by the investigator per IMWG criteria.

Phase 2a: Time to Progression (TTP)

TTP is defined as the time from the date of randomization to the first documentation of confirmed progressive disease as defined by IMWG criteria, assessed by the investigator. Participants without documentation of confirmed progression will be censored at the date of last adequate disease assessment. The analysis will be based on the intent-to-treat (ITT) population.

Phase 2a: Time to Response (TTR)

TTR is defined as time from the date of first dose administration of any study drug to the date of the first documentation of a confirmed PR or better. TTR will be calculated for responders only. TTR will be assessed by the investigator per IMWG criteria.

Phase 2a: Time to Next Treatment (TTNT)

TTNT is defined as the time from the date of first dose administration of any study drug to the date of the first dose initiation of the next line of anticancer therapy for any reason or death from any cause, whichever comes first. Participants who have not started the next-line therapy will be censored at the date last known to be alive before subsequent anticancer therapy.

Phase 2a: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Per Severity

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs will be evaluated as per the NCI CTCAE Version 5.0.

Full Information

NCT ID

NCT05590377

First Posted

October 19, 2022

Last Updated

October 23, 2023

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT05590377

Brief Title

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

Acronym

iinnovate-3

Official Title

A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2023 (Actual)

Primary Completion Date

March 4, 2025 (Anticipated)

Study Completion Date

March 4, 2025 (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

5. Study Description

Brief Summary

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

Detailed Description

The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy in combination with daratumumab in participants with relapsed or refractory multiple myeloma (RRMM). The study will consist of 2 phases: Phase 1 Dose Escalation and a Phase 2a Dose Finding. The study will enroll approximately 58 patients. Approximately 18 participants will be enrolled in the Phase 1 Dose Escalation/De-escalation and two dose levels of modakafusp alfa in combination with daratumumab SC will be selected to be further explored in the randomized Phase 2a Dose Finding part of the study wherein, approximately 40 participants will be randomly assigned by chance (like flipping a coin) to one of the two treatment groups: Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 60 months. Participants who discontinue study drug treatment for reasons other than progressive disease will continue progression-free survival (PFS) follow-up every 4 weeks from the end of treatment (EOT) visit until the occurrence of progressive disease, death, the start of subsequent systemic antineoplastic therapy, study termination, whichever occurs first.

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

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 Dose Escalation

Arm Type

Experimental

Arm Description

Arm Title

Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab

Arm Type

Experimental

Arm Description

Arm Title

Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab

Arm Type

Experimental

Arm Description

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)

Daratumumab

Intervention Description

Daratumumab SC injection

Primary Outcome Measure Information:

Title

Phase 1: Number of Participants with Dose Limiting Toxicities (DLT)

Description

Time Frame

Cycle 1 (cycle length=28 days)

Title

Phase 1: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Per Severity

Description

Time Frame

Up to 60 months

Title

Phase 2a: Overall Response Rate (ORR)

Description

Time Frame

Up to 60 months

Secondary Outcome Measure Information:

Title

Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Volume of Distribution at Steady State After Intravenous Administration for Modakafusp Alfa

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Daratumumab

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for Daratumumab

Time Frame

Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Title

Phase 1: Overall Response Rate (ORR)

Description

ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria.

Time Frame

Up to 60 months

Title

Phase 1 and Phase 2a: Duration of Response (DOR)

Description

Time Frame

Up to 60 months

Title

Phase 1 and Phase 2a: Progression Free Survival (PFS)

Description

Time Frame

up to 60 months

Title

Phase 1 and Phase 2a: Overall Survival (OS)

Description

Time Frame

Up to 60 months

Title

Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies

Time Frame

Up to 60 months

Title

Phase 1 and Phase 2a: Titer of Anti-drug Antibodies

Time Frame

Up to 60 months

Title

Phase 1 and Phase 2a: Number of Participants With Neutralizing Antibodies (NAb) Against Study Drug

Time Frame

Up to 60 months

Title

Phase 1 and Phase 2a: Rate of Measurable [Minimal] Residual Disease Negative (MRD[-]) Complete Response (CR)

Description

Time Frame

Up to 60 months

Title

Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity

Description

Time Frame

Up to 60 months

Title

Phase 2a: Clinical Benefit Rate (CBR)

Description

Time Frame

Up to 60 months

Title

Phase 2a: Duration of Clinical Benefit (DCB)

Description

Time Frame

Up to 60 months

Title

Phase 2a: Disease Control Rate (DCR)

Description

DCR is defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, minimal response, or stable disease (SD) based on investigators' disease assessment per IMWG criteria.

Time Frame

Up to 60 months

Title

Phase 2a: Duration of Disease Control

Description

Time Frame

Up to 60 months

Title

Phase 2a: Time to Progression (TTP)

Description

Time Frame

Up to 60 months

Title

Phase 2a: Time to Response (TTR)

Description

Time Frame

Up to 60 months

Title

Phase 2a: Time to Next Treatment (TTNT)

Description

Time Frame

Up to 60 months

Title

Phase 2a: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Per Severity

Description

Time Frame

Up to 60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented multiple myeloma (MM) diagnosis per IMWG criteria. Measurable disease, defined as at least 1 of the following: Serum M protein ≥0.5 grams per deciliter [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 with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal. For participants in the Phase 1 Dose Escalation only: Must have received at least 3 prior lines of therapy, including at least 1 proteosome inhibitor (PI), 1 immunomodulatory imide drug (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) or therapy. For participants in Phase 2a Dose Finding only: Received 1 to 3 prior line(s) of antimyeloma therapy. Must be refractory to prior lenalidomide treatment. Participants must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment. Documented progressive disease on or after the last regimen. Participants must have PR or better to at least 1 line of prior therapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening. Exclusion Criteria: Prior exposure to modakafusp alfa. Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma. Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE, Version 5 Grade ≤1 or baseline, except for alopecia. Previous allogeneic stem cell transplant at any time or autologous stem cell transplant (ASCT) within 12 weeks of planned start of dosing. Seropositive for hepatitis B, or known history of seropositivity for hepatitis C or of seropositivity for human immunodeficiency virus (HIV). Participant has congestive heart failure (New York Heart Association Grade ≥II), cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension. Participant has QT interval corrected by the Fridericia method >480 milliseconds [msec] (Grade ≥2). Participant has a chronic condition that will require the chronic use of systemic corticosteroids >10 milligrams per day (mg/d) of prednisone or equivalent on top of any required corticosteroids for multiple myeloma (MM).

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

Banner MD Anderson Cancer Center

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

210-450-1132

sumit.madan@bannerhealth.com

First Name & Middle Initial & Last Name & Degree

Sumit Madan

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

77598

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

david.oveisi@cshs.org

First Name & Middle Initial & Last Name & Degree

David Oveisi

Facility Name

James R Berenson, MD Inc.

City

West Hollywood

State/Province

California

ZIP/Postal Code

90069

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

310-623-1222

jberenson@imbcr.org

First Name & Middle Initial & Last Name & Degree

James Berenson

Facility Name

Fort Wayne Medical Oncology and Hematology, Inc

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46060

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

260-484-8830

sunil_gos@yahoo.com

First Name & Middle Initial & Last Name & Degree

Sunil Babu

Facility Name

HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

816-861-4700

suman.kambhampati@va.gov

First Name & Middle Initial & Last Name & Degree

Suman Kambphampati

Facility Name

Tulane University Health Sciences Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

504-988-6070

hsafah@tulane.edu

First Name & Middle Initial & Last Name & Degree

Hana Safah

Facility Name

Floating Hospital for Children at Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

617-636-6454

rcomenzo@tuftsmedicalcenter.org

First Name & Middle Initial & Last Name & Degree

Raymond Comenzo

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63130

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

314-454-8304

markschroeder@wustl.edu

First Name & Middle Initial & Last Name & Degree

Marc Schroder

Facility Name

University 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

716-845-8969

sarah.holstein@unmc.edu

First Name & Middle Initial & Last Name & Degree

Sarah Holstein

Facility Name

Summit Medical Group PA

City

Florham Park

State/Province

New Jersey

ZIP/Postal Code

07932

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

973-538-5210

Ext

2338

wderosa@smgnj.com

First Name & Middle Initial & Last Name & Degree

William DeRosa

Facility Name

New York Cancer and Blood Specialists

City

Bay Shore

State/Province

New York

ZIP/Postal Code

11706

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

978-937-6800

zunigaresearch@nycancer.com

First Name & Middle Initial & Last Name & Degree

Richard Zuniga

Facility Name

Stony Brook University Hospital

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

631-371-6348

mwschuster@gmail.com

First Name & Middle Initial & Last Name & Degree

Michael Schuster

Facility Name

University of Cincinnati - Vontz Center for Molecular Studies

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

513-558-2115

fabered@ucmail.uc.edu

First Name & Middle Initial & Last Name & Degree

Edward Faber

Facility Name

Tranquil Clinical Research

City

Webster

State/Province

Texas

ZIP/Postal Code

78041

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

713-907-6054

joknecht29@gmail.com

First Name & Middle Initial & Last Name & Degree

John Knecht

Facility Name

University of Wisconsin Hospitals and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

608-262-1671

nsc@medicine.wisc.edu

First Name & Middle Initial & Last Name & Degree

Natalie Callander

Facility Name

Concord Repatriation General Hospital

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

nicole.wongdoo@sswahs.nsw.gov.au

First Name & Middle Initial & Last Name & Degree

Nicole Caroline Wong Doo

Facility Name

The Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

390763393

andrew.spencer@monash.edu

First Name & Middle Initial & Last Name & Degree

Andrew Spencer

Facility Name

William Osler Health Center

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6R 3J7

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

philip.kuruvilla@williamoslerhs.ca

First Name & Middle Initial & Last Name & Degree

Phillip Kuruvilla

Facility Name

Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+1 8193461110

Michel.Pavic@USherbrooke.ca

First Name & Middle Initial & Last Name & Degree

Michel Pavic

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

+86 (0) 20-87343088

xiazhj@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Zhong-jun Xia

Facility Name

Wuhan Union Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

15342346782

suncy0618@163.com

First Name & Middle Initial & Last Name & Degree

Chunyan Sun

Facility Name

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

2227301963

qiulg@ihcams.ac.cn

First Name & Middle Initial & Last Name & Degree

Gang An

Facility Name

Zhejiang University School of Medicine - The First Affiliated Hospital (Zhejiang Provincial First Hospital)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

13857311031

caiz@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Zhen Cai

Facility Name

Fakultni nemocnice Olomouc

City

Olomouc

State/Province

Czech

ZIP/Postal Code

77900

Country

Czechia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

jiri.minarik2@fnol.cz

First Name & Middle Initial & Last Name & Degree

Jiri Minarik

Facility Name

Vseobecna Fakultni Nemocnice v Praze

City

Prague

State/Province

Praha

ZIP/Postal Code

12802

Country

Czechia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+420 224962551

spicka@cesnet.cz

First Name & Middle Initial & Last Name & Degree

Ivan Spicka

Facility Name

FNsP Ostrava

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

597372088

roman.hajek@fno.cz

First Name & Middle Initial & Last Name & Degree

Roman Hajek

Facility Name

CHRU Lille

City

Lille

State/Province

Hauts-de-France

ZIP/Postal Code

59037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+33 3 20 44 57 13

salomon.manier@chru-lille.fr

First Name & Middle Initial & Last Name & Degree

Salomon Manier

Facility Name

Institut Paoli-Calmettes

City

Marseille

State/Province

Provence-Alpes-Cote d'Azur

ZIP/Postal Code

13273

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+33 4 91 22 38 66

schianojm@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Jean-Marc Schiano de Colella

Facility Name

Klinikum Nuernberg Nord

City

Nuremberg

State/Province

Bavaria

ZIP/Postal Code

90419

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+49-911-398-3887

stefan.knop@klinikum-nuernberg.de

First Name & Middle Initial & Last Name & Degree

Stefan Knop

Facility Name

Universitaetsklinikum Koeln

City

Cologne

State/Province

North Rhine-Westphalia

ZIP/Postal Code

50931

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

22147886712

c.scheid@uni-koeln.de

First Name & Middle Initial & Last Name & Degree

Cristof Scheid

Facility Name

Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)

City

Debrecen

State/Province

Norhtern Great Plain

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

52255601

illesarpaddr@gmail.com

First Name & Middle Initial & Last Name & Degree

Arpad Illes

Facility Name

Semmelweis University

City

Budapest

State/Province

Pannonia

ZIP/Postal Code

1088

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+36 208250799

vargager@gmail.com

First Name & Middle Initial & Last Name & Degree

Gergely Varga

Facility Name

Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet

City

Budapest

State/Province

Pannonia

ZIP/Postal Code

1097

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

209139907

gmikala@dpckorhaz.hu

First Name & Middle Initial & Last Name & Degree

Gabor Mikala

Facility Name

Chonnam National University Hwasun Hospital

City

Hwasun

State/Province

Jeollanam-do

ZIP/Postal Code

58128

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

shglory@hanmail.net

First Name & Middle Initial & Last Name & Degree

Sung-Hoon Jung

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+82 234103459

kihyunk@skky.edu

First Name & Middle Initial & Last Name & Degree

Kihyun Kim

Facility Name

The Catholic University of Korea, Seoul St. Marys Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

+82 222586053

ckmin@catholic.ac.kr

First Name & Middle Initial & Last Name & Degree

Chang Ki Min

Facility Name

Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc.

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

7877717933

cabanillasmd@gmail.com

First Name & Middle Initial & Last Name & Degree

Fernando Cabanillas Escalona

Facility Name

Hospital Universitario Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

934893000

mgironel@vhebron.net

First Name & Middle Initial & Last Name & Degree

Mercedes Gironella Mesa

Facility Name

Fundacion Instituto de Estudios Ciencias de la Salud de Castilla y Leon-Investigacion Biomedica de Salamanca (IBSAL)

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

923291200

mvmateos@usal.es

First Name & Middle Initial & Last Name & Degree

Maria Victoria Mateos Manteca

Facility Name

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

1132068433

gordoncook@nhs.net

First Name & Middle Initial & Last Name & Degree

Gordon Cook

Facility Name

University Hospitals of Derby and Burton NHS Foundation Trust

City

Derby

ZIP/Postal Code

DE22 3NE

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Site Contact

Phone

1332783095

firas.abed@nhs.net

First Name & Middle Initial & Last Name & Degree

Firas Al-Kaisi

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/a0702cdc2a2c4eec?idFilter=%5B%22TAK-573-2001%22%5D

Description

To obtain more information on the study, click this link.

Learn more about this trial

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

We'll reach out to this number within 24 hrs