A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
Isatuximab SC-OBDS: Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
Montelukast: Pharmaceutical form:As per local commercial product-Route of administration:Oral
Dexamethasone: Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Acetaminophen: Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Diphenhydramine: Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
Methylprednisolone: Pharmaceutical form:As per local commercial product-Route of administration:IV
Carfilzomib: Pharmaceutical form:As per local commercial product-Route of administration:IV
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.
Eligibility
Primary outcome measure(s)
- Overall response rate (ORR) — 6 months after the Last Participant In (LPI) i.e., approximately 32 months
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.
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic in Arizona - Phoenix- Site Number : 8400058 | Phoenix | Arizona | Recruiting |
| Los Angeles Hematology Oncology Medical Group- Site Number : 8400027 | Los Angeles | California | Recruiting |
| Private Practice - Dr. James R. Berenson- Site Number : 8400044 | West Hollywood | California | Recruiting |
| Smilow Cancer Center at Yale-New Haven- Site Number : 8400020 | New Haven | Connecticut | Recruiting |
| Maryland Oncology Hematology- Site Number : 8400038 | Washington D.C. | District of Columbia | Recruiting |
| Life Clinical Trials - Coral Springs- Site Number : 8400055 | Coral Springs | Florida | Recruiting |
| Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031 | Fort Lauderdale | Florida | Recruiting |
| Mayo Clinic in Florida- Site Number : 8400002 | Jacksonville | Florida | Recruiting |
| The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054 | Lakeland | Florida | Recruiting |
| D&H Pompano Research Center- Site Number : 8400049 | Margate | Florida | Recruiting |
| Millennium Oncology - Pembroke Pines- Site Number : 8400011 | Pembroke Pines | Florida | Recruiting |
| BRCR Global- Site Number : 8400008 | Plantation | Florida | Recruiting |
| Florida Cancer Specialists - North- Site Number : 8400030 | St. Petersburg | Florida | Recruiting |
| Pontchartrain Cancer Center - Covington- Site Number : 8400046 | Covington | Louisiana | Recruiting |
| Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005 | Boston | Massachusetts | Recruiting |
| Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036 | Dearborn | Michigan | Recruiting |
| Hematology Oncology Consultants - Royal Oak- Site Number : 8400039 | Royal Oak | Michigan | Recruiting |
| Alliance for Multispeciality Research - Kansas City- Site Number : 8400056 | Kansas City | Missouri | Recruiting |
| Washington University- Site Number : 8400007 | St Louis | Missouri | Recruiting |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021 | Hackensack | New Jersey | Recruiting |
| San Juan Oncology Associates- Site Number : 8400016 | Farmington | New Mexico | Recruiting |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003 | New York | New York | Recruiting |
| Duke University Medical Center- Site Number : 8400018 | Durham | North Carolina | Recruiting |
| Gabrail Cancer Center- Site Number : 8400010 | Canton | Ohio | Recruiting |
| University of Cincinnati Medical Center- Site Number : 8400043 | Cincinnati | Ohio | Recruiting |
| Oncology Hematology Care - Kenwood- Site Number : 8400014 | Cincinnati | Ohio | Recruiting |
| Roper Saint Francis Healthcare- Site Number : 8400013 | Charleston | South Carolina | Recruiting |
| Prisma Health Cancer Institute - Greenville- Site Number : 8400019 | Greenville | South Carolina | Recruiting |
| Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001 | Spartanburg | South Carolina | Recruiting |
| Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035 | Knoxville | Tennessee | Recruiting |
| University of Tennessee Medical Center- Site Number : 8400006 | Knoxville | Tennessee | Recruiting |
| Tennessee Oncology Nashville- Site Number : 8400012 | Nashville | Tennessee | Recruiting |
| Northern Virginia Oncology Group- Site Number : 8400045 | Fairfax | Virginia | Recruiting |
| SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009 | Madison | Wisconsin | Recruiting |
More Sanofi trials in Israel
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06356571 on ClinicalTrials.gov ↗ ← All trials in Israel