RecruitingPhase 2NCT06356571

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

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)

Sponsor

Sanofi

Enrollment

64 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Plasma Cell Myeloma Refractory

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a subcutaneous (under-the-skin) injection form of isatuximab — an immunotherapy drug — given with two other drugs (carfilzomib and dexamethasone) for patients with multiple myeloma (a blood cancer) that has returned or stopped responding to previous treatment. **You may be eligible if...** - You have a confirmed diagnosis of multiple myeloma - Your disease has relapsed or become refractory (resistant), and you have had between 1 and 3 prior lines of treatment - Your disease is measurable by standard blood or urine tests - You agree to use effective contraception during and after treatment **You may NOT be eligible if...** - Your myeloma never responded to any prior therapy (primary refractory disease) - You have health conditions that would make participation unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab SC-OBDS

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

DRUGMontelukast

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

DRUGDexamethasone

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

DRUGAcetaminophen

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

DRUGDiphenhydramine

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

DRUGMethylprednisolone

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

DRUGCarfilzomib

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

View Full Details on ClinicalTrials.gov

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NCT06356571

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