A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Start Date
3/17/2025
Completion Date
7/15/2027
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.
Detailed Description
The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. A cycle duration is 28 days. After study treatment discontinuation, participants will return to the study site 30 days after the last dose of study treatment for the EOT visit or before further anti-myeloma therapy initiation, whichever comes first.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Isatuximab SC-OBDS
Montelukast
Dexamethasone
Acetaminophen
Diphenhydramine
Methylprednisolone
Carfilzomib
Conditions
Locations
Mayo Clinic in Arizona - Phoenix- Site Number : 8400058
Phoenix, Arizona 85054
United States
Los Angeles Hematology Oncology Medical Group- Site Number : 8400027
Los Angeles, California 90017
United States
Private Practice - Dr. James R. Berenson- Site Number : 8400044
West Hollywood, California 90069
United States
Smilow Cancer Center at Yale-New Haven- Site Number : 8400020
New Haven, Connecticut 06511
United States
Maryland Oncology Hematology- Site Number : 8400038
Washington D.C., District of Columbia 20017
United States
Life Clinical Trials - Coral Springs- Site Number : 8400055
Coral Springs, Florida 33071
United States
Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031
Fort Lauderdale, Florida 33309
United States
Mayo Clinic in Florida- Site Number : 8400002
Jacksonville, Florida 32224
United States
The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054
Lakeland, Florida 33812
United States
D&H Pompano Research Center- Site Number : 8400049
Margate, Florida 33063
United States
Millennium Oncology - Pembroke Pines- Site Number : 8400011
Pembroke Pines, Florida 33024
United States
BRCR Global- Site Number : 8400008
Plantation, Florida 33322
United States
Florida Cancer Specialists - North- Site Number : 8400030
St. Petersburg, Florida 33705
United States
Pontchartrain Cancer Center - Covington- Site Number : 8400046
Covington, Louisiana 70433
United States
Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005
Boston, Massachusetts 02215
United States
Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036
Dearborn, Michigan 48126
United States
Hematology Oncology Consultants - Royal Oak- Site Number : 8400039
Royal Oak, Michigan 48073
United States
Alliance for Multispeciality Research - Kansas City- Site Number : 8400056
Kansas City, Missouri 64114
United States
Washington University- Site Number : 8400007
St Louis, Missouri 63110
United States
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021
Hackensack, New Jersey 07601
United States
San Juan Oncology Associates- Site Number : 8400016
Farmington, New Mexico 87401
United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003
New York, New York 10065
United States
Duke University Medical Center- Site Number : 8400018
Durham, North Carolina 27710
United States
Gabrail Cancer Center- Site Number : 8400010
Canton, Ohio 44718
United States
University of Cincinnati Medical Center- Site Number : 8400043
Cincinnati, Ohio 45219
United States
Oncology Hematology Care - Kenwood- Site Number : 8400014
Cincinnati, Ohio 45236
United States
Roper Saint Francis Healthcare- Site Number : 8400013
Charleston, South Carolina 29401
United States
Prisma Health Cancer Institute - Greenville- Site Number : 8400019
Greenville, South Carolina 29615
United States
Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001
Spartanburg, South Carolina 29303
United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035
Knoxville, Tennessee 37909
United States
University of Tennessee Medical Center- Site Number : 8400006
Knoxville, Tennessee 37920
United States
Tennessee Oncology Nashville- Site Number : 8400012
Nashville, Tennessee 37203
United States
Northern Virginia Oncology Group- Site Number : 8400045
Fairfax, Virginia 22031
United States
SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009
Madison, Wisconsin 53715
United States