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NCT06356571PHASE2Recruiting

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

Sanofi

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

Inclusion Criteria: * Participants must have a documented diagnosis of MM. * Participants with measurable disease defined as at least one of the following: * Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or * Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or * Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy. * Contraceptive use by \[men and women\] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male participants agree to practice true abstinence or agree to use contraception while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP XE " FCBP " \\f Abbreviation \\t "female of childbearing potential" ) or agrees to practice complete abstinence or use contraception. * Capable of giving signed informed consent. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course. * Participants with prior anti-CD38 treatment if: a) administered \< 6 months before first isatuximab administration or, b) intolerant to the anti-CD38 previously received. * Participants who are refractory to carfilzomib. * Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents. * Participants with contraindication to dexamethasone and/or to carfilzomib. * Any anti-myeloma drug treatment within 14 days before the first isatuximab administration, including dexamethasone. * Prior allogenic HSC transplant with active graft versus host disease (GvHD XE " GvHD " \\f Abbreviation \\t "graft versus host disease" ) (GvHD any grade and/or being under immunosuppressive treatment within the last 2 months). * Any major procedure within 14 days before the first isatuximab administration: plasmapheresis, major surgery (kyphoplasty is not considered a major procedure), radiotherapy. * Vaccination with a live vaccine within 4 weeks before the first isatuximab administration. Seasonal flu vaccines that do not contain live virus are permitted. * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Interventions

DRUG

Isatuximab SC-OBDS

DRUG

Montelukast

DRUG

Dexamethasone

DRUG

Acetaminophen

DRUG

Diphenhydramine

DRUG

Methylprednisolone

DRUG

Carfilzomib

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Conditions

Plasma Cell Myeloma Refractory

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