A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Sanofi
- Study ID
- NCT06356571
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Plasma Cell Myeloma Refractory
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Isatuximab SC-OBDS — DRUGPharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
- Montelukast — DRUGPharmaceutical form:As per local commercial product-Route of administration:Oral
- Dexamethasone — DRUGPharmaceutical form:As per local commercial product-Route of administration:Oral or IV
- Acetaminophen — DRUGPharmaceutical form:As per local commercial product-Route of administration:Oral or IV
- Diphenhydramine — DRUGPharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
- Methylprednisolone — DRUGPharmaceutical form:As per local commercial product-Route of administration:IV
- Carfilzomib — DRUGPharmaceutical form:As per local commercial product-Route of administration:IV
Study Details
The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.
Key Dates
- Start date
- Mar 17, 2025
- Status verified
- Feb 2026
- Primary completion
- Jan 8, 2027
- Completion
- Jul 15, 2027
Study Design
- Enrollment
- 64 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Isatuximab in combination with weekly carfilzomib and dexamethasoneParticipants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days.
Primary Outcome Measure
Overall response rate (ORR) [ Time Frame: 6 months after the Last Participant In (LPI) i.e., approximately 32 months ]
Central Contacts
- Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
Locations (34)
Find similar trials in Phoenix, AZ
By research site
Mayo Clinic in Arizona - Phoenix· Phoenix, AZLos Angeles Hematology Oncology Medical Group· Los Angeles, CAPrivate Practice - Dr. James R. Berenson· West Hollywood, CASmilow Cancer Center at Yale-New Haven· New Haven, CTMaryland Oncology Hematology· Washington D.C., DCLife Clinical Trials - Coral Springs· Coral Springs, FL
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