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A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Sponsor: Sanofi
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.
Official title: A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2025-03-17
Completion Date
2027-07-15
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
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
Locations (34)
Mayo Clinic in Arizona - Phoenix- Site Number : 8400058
Phoenix, Arizona, United States
Los Angeles Hematology Oncology Medical Group- Site Number : 8400027
Los Angeles, California, United States
Private Practice - Dr. James R. Berenson- Site Number : 8400044
West Hollywood, California, United States
Smilow Cancer Center at Yale-New Haven- Site Number : 8400020
New Haven, Connecticut, United States
Maryland Oncology Hematology- Site Number : 8400038
Washington D.C., District of Columbia, United States
Life Clinical Trials - Coral Springs- Site Number : 8400055
Coral Springs, Florida, United States
Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031
Fort Lauderdale, Florida, United States
Mayo Clinic in Florida- Site Number : 8400002
Jacksonville, Florida, United States
The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054
Lakeland, Florida, United States
D&H Pompano Research Center- Site Number : 8400049
Margate, Florida, United States
Millennium Oncology - Pembroke Pines- Site Number : 8400011
Pembroke Pines, Florida, United States
BRCR Global- Site Number : 8400008
Plantation, Florida, United States
Florida Cancer Specialists - North- Site Number : 8400030
St. Petersburg, Florida, United States
Pontchartrain Cancer Center - Covington- Site Number : 8400046
Covington, Louisiana, United States
Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005
Boston, Massachusetts, United States
Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036
Dearborn, Michigan, United States
Hematology Oncology Consultants - Royal Oak- Site Number : 8400039
Royal Oak, Michigan, United States
Alliance for Multispeciality Research - Kansas City- Site Number : 8400056
Kansas City, Missouri, United States
Washington University- Site Number : 8400007
St Louis, Missouri, United States
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021
Hackensack, New Jersey, United States
San Juan Oncology Associates- Site Number : 8400016
Farmington, New Mexico, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003
New York, New York, United States
Duke University Medical Center- Site Number : 8400018
Durham, North Carolina, United States
Gabrail Cancer Center- Site Number : 8400010
Canton, Ohio, United States
University of Cincinnati Medical Center- Site Number : 8400043
Cincinnati, Ohio, United States
Oncology Hematology Care - Kenwood- Site Number : 8400014
Cincinnati, Ohio, United States
Roper Saint Francis Healthcare- Site Number : 8400013
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Greenville- Site Number : 8400019
Greenville, South Carolina, United States
Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001
Spartanburg, South Carolina, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035
Knoxville, Tennessee, United States
University of Tennessee Medical Center- Site Number : 8400006
Knoxville, Tennessee, United States
Tennessee Oncology Nashville- Site Number : 8400012
Nashville, Tennessee, United States
Northern Virginia Oncology Group- Site Number : 8400045
Fairfax, Virginia, United States
SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009
Madison, Wisconsin, United States