A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma
Megadott ok: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a and the study was terminated early.
Key facts
- Where
- Bay Shore, Boston, Cincinnati, Florham Park, Fort Wayne, Gilbert, Los Angeles, New Orleans, Omaha, Overland Park, St Louis, Stony Brook és Webster, Egyesült ÁllamokSee the 13 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- New York Cancer and Blood SpecialistsBay Shore, Egyesült ÁllamokNo longer taking part
- Floating Hospital for Children at Tufts Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- University of Cincinnati - Vontz Center for Molecular StudiesCincinnati, Egyesült ÁllamokNo longer taking part
- Summit Medical Group PAFlorham Park, Egyesült ÁllamokNo longer taking part
- Fort Wayne Medical Oncology and Hematology, IncFort Wayne, Egyesült ÁllamokNo longer taking part
- Banner MD Anderson Cancer CenterGilbert, Egyesült ÁllamokNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- Tulane University Health Sciences CenterNew Orleans, Egyesült ÁllamokNo longer taking part
- University of Nebraska Medical CenterOmaha, Egyesült ÁllamokNo longer taking part
- HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)Overland Park, Egyesült ÁllamokNo longer taking part
- Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
- Stony Brook University HospitalStony Brook, Egyesült ÁllamokNo longer taking part
- Tranquil Clinical ResearchWebster, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Teva Branded Pharmaceutical Products R&D LLC
- Trial code
- NCT05590377
- Record updated
- 2026. január 30.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Prior exposure to modakafusp alfa; 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; Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma; 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 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); Participant has QT interval corrected by the Fridericia method >480 milliseconds [msec] (Grade ≥2).