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

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05590377

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

15

Starts

2023-01-23

Expected to finish

2024-05-22

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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