NCT06356571 A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
| NCT ID | NCT06356571 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sanofi |
| Condition | Plasma Cell Myeloma Refractory |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-01-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2025-03-17 with a primary completion date of 2027-01-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ Contact-US@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT06356571 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Plasma Cell Myeloma Refractory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06356571 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06356571 currently recruiting?
Yes, NCT06356571 is actively recruiting participants. Contact the research team at Contact-US@sanofi.com for enrollment information.
Where is the NCT06356571 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, West Hollywood, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT06356571 clinical trial?
NCT06356571 is sponsored by Sanofi. The trial plans to enroll 64 participants.