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RECRUITING
NCT06356571
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Isatuximab SC-OBDS

Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS

DRUG

Montelukast

Pharmaceutical form:As per local commercial product-Route of administration:Oral

DRUG

Dexamethasone

Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV

DRUG

Acetaminophen

Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV

DRUG

Diphenhydramine

Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)

DRUG

Methylprednisolone

Pharmaceutical form:As per local commercial product-Route of administration:IV

DRUG

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