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NCT06356571 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 2 study of Plasma Cell Myeloma Refractory, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT06356571: Recruiting Phase 2 study of Plasma Cell Myeloma Refractory, sponsored by Sanofi.
NCT06356571 is a Phase 2 study of Plasma Cell Myeloma Refractory that is actively recruiting participants, run by Sanofi. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06356571, a Phase 2 study of Plasma Cell Myeloma Refractory, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator.
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Dexamethasone
- DRUG Montelukast
- DRUG Diphenhydramine
- DRUG Isatuximab SC-OBDS
Study Locations (20)
Florida
- Life Clinical Trials - Coral Springs- Site Number : 8400055 - Coral Springs
- Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031 - Fort Lauderdale
- Mayo Clinic in Florida- Site Number : 8400002 - Jacksonville
- The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054 - Lakeland
- D&H Pompano Research Center- Site Number : 8400049 - Margate
- Millennium Oncology - Pembroke Pines- Site Number : 8400011 - Pembroke Pines
- BRCR Global- Site Number : 8400008 - Plantation
- Florida Cancer Specialists - North- Site Number : 8400030 - St. Petersburg
California
- Los Angeles Hematology Oncology Medical Group- Site Number : 8400027 - Los Angeles
- Private Practice - Dr. James R. Berenson- Site Number : 8400044 - West Hollywood
Michigan
- Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036 - Dearborn
- Hematology Oncology Consultants - Royal Oak- Site Number : 8400039 - Royal Oak
Missouri
- Alliance for Multispeciality Research - Kansas City- Site Number : 8400056 - Kansas City
- Washington University- Site Number : 8400007 - St Louis
Arizona
- Mayo Clinic in Arizona - Phoenix- Site Number : 8400058 - Phoenix
Connecticut
- Smilow Cancer Center at Yale-New Haven- Site Number : 8400020 - New Haven
District of Columbia
- Maryland Oncology Hematology- Site Number : 8400038 - Washington D.C.
Louisiana
- Pontchartrain Cancer Center - Covington- Site Number : 8400046 - Covington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2025-03-17 |
| Est. Completion | 2027-07-15 |
| Phase | Phase 2 |
What NCT06356571 shows while recruiting
NCT06356571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Plasma Cell Myeloma Refractory appearing as the primary indexed condition, and to 5 interventions - of which Acetaminophen is the first listed.
NCT06356571 names 20 study sites across 10 states, led by Florida, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT06356571 about?
NCT06356571 is a clinical study titled "A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma". 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.
What is the current status of trial NCT06356571?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2025-03-17. Estimated completion is 2027-07-15.
What conditions does trial NCT06356571 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma Refractory.
What interventions are being tested in trial NCT06356571?
The interventions under investigation include: Acetaminophen (DRUG), Dexamethasone (DRUG), Montelukast (DRUG), Diphenhydramine (DRUG), Isatuximab SC-OBDS (DRUG).
Who is sponsoring clinical trial NCT06356571?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06356571 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06356571's enrollment target sits among peer trials
64 996th of 2000 higher than 993 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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