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

Recruiting now · Phase 2

Conditions studied: Plasma Cell Myeloma Refractory

In brief

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.

Key facts

Study ID

NCT06356571

Run by

Sanofi

People needed

64

Starts

2025-03-17

Expected to finish

2027-07-15

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic in Arizona - Phoenix- Site Number : 8400058 — Phoenix, Arizona, United States (enrolling)
• Los Angeles Hematology Oncology Medical Group- Site Number : 8400027 — Los Angeles, California, United States (enrolling)
• Private Practice - Dr. James R. Berenson- Site Number : 8400044 — West Hollywood, California, United States (enrolling)
• Smilow Cancer Center at Yale-New Haven- Site Number : 8400020 — New Haven, Connecticut, United States (enrolling)
• Maryland Oncology Hematology- Site Number : 8400038 — Washington D.C., District of Columbia, United States (enrolling)
• Life Clinical Trials - Coral Springs- Site Number : 8400055 — Coral Springs, Florida, United States (enrolling)
• Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031 — Fort Lauderdale, Florida, United States (enrolling)
• Mayo Clinic in Florida- Site Number : 8400002 — Jacksonville, Florida, United States (enrolling)
• The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054 — Lakeland, Florida, United States (enrolling)
• D&H Pompano Research Center- Site Number : 8400049 — Margate, Florida, United States (enrolling)
• Millennium Oncology - Pembroke Pines- Site Number : 8400011 — Pembroke Pines, Florida, United States (enrolling)
• BRCR Global- Site Number : 8400008 — Plantation, Florida, United States (enrolling)
• Florida Cancer Specialists - North- Site Number : 8400030 — St. Petersburg, Florida, United States (enrolling)
• Pontchartrain Cancer Center - Covington- Site Number : 8400046 — Covington, Louisiana, United States (enrolling)
• Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005 — Boston, Massachusetts, United States (enrolling)
• Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036 — Dearborn, Michigan, United States (enrolling)
• Hematology Oncology Consultants - Royal Oak- Site Number : 8400039 — Royal Oak, Michigan, United States (enrolling)
• Alliance for Multispeciality Research - Kansas City- Site Number : 8400056 — Kansas City, Missouri, United States (enrolling)
• Washington University- Site Number : 8400007 — St Louis, Missouri, United States (enrolling)
• Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021 — Hackensack, New Jersey, United States (enrolling)
• San Juan Oncology Associates- Site Number : 8400016 — Farmington, New Mexico, United States (enrolling)
• Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003 — New York, New York, United States (enrolling)
• Duke University Medical Center- Site Number : 8400018 — Durham, North Carolina, United States (enrolling)
• Gabrail Cancer Center- Site Number : 8400010 — Canton, Ohio, United States (enrolling)
• University of Cincinnati Medical Center- Site Number : 8400043 — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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