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Investigating Isatuximab with Carfilzomib and Dexamethasone for Multiple Myeloma

A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

PHASE2 · Sanofi · NCT06356571

This study is testing if a new combination of isatuximab, carfilzomib, and dexamethasone can help adults with relapsed or stubborn multiple myeloma feel better after trying other treatments.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment64 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi (industry)
Drugs / interventionsisatuximab
Locations34 sites (Phoenix, Arizona and 33 other locations)
Trial IDNCT06356571 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of subcutaneous isatuximab combined with weekly carfilzomib and dexamethasone in adults with relapsed and/or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Participants will undergo a screening period of up to 28 days, followed by a treatment phase lasting 12 months, with regular follow-ups until the end of treatment and beyond. The primary goal is to assess the overall response rate to this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with relapsed and/or refractory multiple myeloma who have received between 1 to 3 prior lines of therapy.

Not a fit: Patients who have not been diagnosed with multiple myeloma or have received more than 3 prior lines of therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating multiple myeloma, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Plasma Cell Myeloma Refractory, Anti CD38 monoclonal antibody, SARCLISA

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.