Recruiting
Phase 2

Isatuximab & Carfilzomib

Sponsor:

Sanofi

Code:

NCT06356571

Conditions

Plasma Cell Myeloma Refractory

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Isatuximab SC-OBDS

Montelukast

Dexamethasone

Acetaminophen

Diphenhydramine

Study Details

Brief 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.

Conditions

Plasma Cell Myeloma Refractory

Study ID

NCT06356571

Start date

Mar 17, 2025

Status verified date

Feb, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Jan 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Isatuximab in combination with weekly carfilzomib and dexamethasone

Participants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days.

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

Primary outcome measure

  • Overall response rate (ORR) [ Time Frame: 6 months after the Last Participant In (LPI) i.e., approximately 32 months ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Mayo Clinic in Arizona - Phoenix- Site Number : 8400058

Recruiting

Phoenix, Arizona, United States, 85054

Los Angeles Hematology Oncology Medical Group- Site Number : 8400027

Recruiting

Los Angeles, California, United States, 90017

Private Practice - Dr. James R. Berenson- Site Number : 8400044

Recruiting

West Hollywood, California, United States, 90069

Smilow Cancer Center at Yale-New Haven- Site Number : 8400020

Recruiting

New Haven, Connecticut, United States, 06511

Maryland Oncology Hematology- Site Number : 8400038

Recruiting

Washington D.C., District of Columbia, United States, 20017

Life Clinical Trials - Coral Springs- Site Number : 8400055

Recruiting

Coral Springs, Florida, United States, 33071

Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031

Recruiting

Fort Lauderdale, Florida, United States, 33309

Mayo Clinic in Florida- Site Number : 8400002

Recruiting

Jacksonville, Florida, United States, 32224

The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054

Recruiting

Lakeland, Florida, United States, 33812

D&H Pompano Research Center- Site Number : 8400049

Recruiting

Margate, Florida, United States, 33063

Millennium Oncology - Pembroke Pines- Site Number : 8400011

Recruiting

Pembroke Pines, Florida, United States, 33024

BRCR Global- Site Number : 8400008

Recruiting

Plantation, Florida, United States, 33322

Florida Cancer Specialists - North- Site Number : 8400030

Recruiting

St. Petersburg, Florida, United States, 33705

Pontchartrain Cancer Center - Covington- Site Number : 8400046

Recruiting

Covington, Louisiana, United States, 70433

Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005

Recruiting

Boston, Massachusetts, United States, 02215

Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036

Recruiting

Dearborn, Michigan, United States, 48126

Hematology Oncology Consultants - Royal Oak- Site Number : 8400039

Recruiting

Royal Oak, Michigan, United States, 48073

Alliance for Multispeciality Research - Kansas City- Site Number : 8400056

Recruiting

Kansas City, Missouri, United States, 64114

Washington University- Site Number : 8400007

Recruiting

St Louis, Missouri, United States, 63110

Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021

Recruiting

Hackensack, New Jersey, United States, 07601

San Juan Oncology Associates- Site Number : 8400016

Recruiting

Farmington, New Mexico, United States, 87401

Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003

Recruiting

New York, New York, United States, 10065

Duke University Medical Center- Site Number : 8400018

Recruiting

Durham, North Carolina, United States, 27710

Gabrail Cancer Center- Site Number : 8400010

Recruiting

Canton, Ohio, United States, 44718

University of Cincinnati Medical Center- Site Number : 8400043

Recruiting

Cincinnati, Ohio, United States, 45219

Oncology Hematology Care - Kenwood- Site Number : 8400014

Recruiting

Cincinnati, Ohio, United States, 45236

Roper Saint Francis Healthcare- Site Number : 8400013

Recruiting

Charleston, South Carolina, United States, 29401

Prisma Health Cancer Institute - Greenville- Site Number : 8400019

Recruiting

Greenville, South Carolina, United States, 29615

Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001

Recruiting

Spartanburg, South Carolina, United States, 29303

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035

Recruiting

Knoxville, Tennessee, United States, 37909

University of Tennessee Medical Center- Site Number : 8400006

Recruiting

Knoxville, Tennessee, United States, 37920

Tennessee Oncology Nashville- Site Number : 8400012

Recruiting

Nashville, Tennessee, United States, 37203

Northern Virginia Oncology Group- Site Number : 8400045

Recruiting

Fairfax, Virginia, United States, 22031

SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009

Recruiting

Madison, Wisconsin, United States, 53715

More Information

Sponsor

Sanofi

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Anti CD38 monoclonal antibody
  • SARCLISA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanofi on 2026-02-23.