🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06356571
Recruiting Phase 2

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

NCT06356571 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2025-03-17
Last updated
2026-02-23

Condition(s) studied

Plasma Cell Myeloma Refractory

Investigational drug(s) / intervention(s)

Isatuximab SC-OBDSMontelukastDexamethasoneAcetaminophenDiphenhydramineMethylprednisoloneCarfilzomib

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Mayo Clinic in Arizona - Phoenix- Site Number : 8400058 Phoenix Arizona Recruiting
Los Angeles Hematology Oncology Medical Group- Site Number : 8400027 Los Angeles California Recruiting
Private Practice - Dr. James R. Berenson- Site Number : 8400044 West Hollywood California Recruiting
Smilow Cancer Center at Yale-New Haven- Site Number : 8400020 New Haven Connecticut Recruiting
Maryland Oncology Hematology- Site Number : 8400038 Washington D.C. District of Columbia Recruiting
Life Clinical Trials - Coral Springs- Site Number : 8400055 Coral Springs Florida Recruiting
Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031 Fort Lauderdale Florida Recruiting
Mayo Clinic in Florida- Site Number : 8400002 Jacksonville Florida Recruiting
The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054 Lakeland Florida Recruiting
D&H Pompano Research Center- Site Number : 8400049 Margate Florida Recruiting
Millennium Oncology - Pembroke Pines- Site Number : 8400011 Pembroke Pines Florida Recruiting
BRCR Global- Site Number : 8400008 Plantation Florida Recruiting
Florida Cancer Specialists - North- Site Number : 8400030 St. Petersburg Florida Recruiting
Pontchartrain Cancer Center - Covington- Site Number : 8400046 Covington Louisiana Recruiting
Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005 Boston Massachusetts Recruiting
Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036 Dearborn Michigan Recruiting
Hematology Oncology Consultants - Royal Oak- Site Number : 8400039 Royal Oak Michigan Recruiting
Alliance for Multispeciality Research - Kansas City- Site Number : 8400056 Kansas City Missouri Recruiting
Washington University- Site Number : 8400007 St Louis Missouri Recruiting
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021 Hackensack New Jersey Recruiting
San Juan Oncology Associates- Site Number : 8400016 Farmington New Mexico Recruiting
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003 New York New York Recruiting
Duke University Medical Center- Site Number : 8400018 Durham North Carolina Recruiting
Gabrail Cancer Center- Site Number : 8400010 Canton Ohio Recruiting
University of Cincinnati Medical Center- Site Number : 8400043 Cincinnati Ohio Recruiting
Oncology Hematology Care - Kenwood- Site Number : 8400014 Cincinnati Ohio Recruiting
Roper Saint Francis Healthcare- Site Number : 8400013 Charleston South Carolina Recruiting
Prisma Health Cancer Institute - Greenville- Site Number : 8400019 Greenville South Carolina Recruiting
Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001 Spartanburg South Carolina Recruiting
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035 Knoxville Tennessee Recruiting
University of Tennessee Medical Center- Site Number : 8400006 Knoxville Tennessee Recruiting
Tennessee Oncology Nashville- Site Number : 8400012 Nashville Tennessee Recruiting
Northern Virginia Oncology Group- Site Number : 8400045 Fairfax Virginia Recruiting
SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009 Madison Wisconsin Recruiting

On this site

📄 Singulair (montelukast) drug profile → 📄 Tylenol (acetaminophen) drug profile →

More Sanofi trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06356571 on ClinicalTrials.gov ↗ ← All trials in the USA