A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT05590377
Last Updated: 2025-12-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2023-01-23
2024-05-22
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
Modakafusp alfa 80 mg, infusion, intravenously (IV), 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
Modakafusp alfa intravenous infusion
Daratumumab
Daratumumab SC injection
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
Modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 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
Modakafusp alfa intravenous infusion
Daratumumab
Daratumumab SC injection
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
Modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 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
Modakafusp alfa intravenous infusion
Daratumumab
Daratumumab SC injection
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
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
Modakafusp alfa intravenous infusion
Daratumumab
Daratumumab SC injection
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
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.
Modakafusp Alfa
Modakafusp alfa intravenous infusion
Daratumumab
Daratumumab SC injection
Interventions
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Modakafusp Alfa
Modakafusp alfa intravenous infusion
Daratumumab
Daratumumab SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
Exclusion Criteria
2. Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma.
3. 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.
4. Previous allogeneic stem cell transplant at any time or autologous stem cell transplant (ASCT) within 12 weeks of planned start of dosing.
5. Seropositive for hepatitis B, or known history of seropositivity for hepatitis C or of seropositivity for human immunodeficiency virus (HIV).
6. 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.
7. Participant has QT interval corrected by the Fridericia method \>480 milliseconds \[msec\] (Grade ≥2).
8. 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).
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda (Note: This product was divested to Teva Pharmaceuticals in 2025)
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, United States
HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)
Overland Park, Kansas, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Summit Medical Group PA
Florham Park, New Jersey, United States
New York Cancer and Blood Specialists
Bay Shore, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
University of Cincinnati - Vontz Center for Molecular Studies
Cincinnati, Ohio, United States
Tranquil Clinical Research
Webster, Texas, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont
Sherbrooke, Quebec, Canada
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Wuhan Union Hospital
Wuhan, Hubei, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Zhejiang University School of Medicine - The First Affiliated Hospital (Zhejiang Provincial First Hospital)
Hangzhou, Zhejiang, China
CHRU Lille
Lille, Hauts-de-France, France
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Fundacion Instituto de Estudios Ciencias de la Salud de Castilla y Leon-Investigacion Biomedica de Salamanca (IBSAL)
Salamanca, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click this link.
Other Identifiers
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TAK-573-2001
Identifier Type: -
Identifier Source: org_study_id
2022-002169-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id