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

Study on Investigational Medication for Treating Difficult Multiple Myeloma

Recruiting
18 years or above
All
Phase 2
64 participants needed
3 Locations

Study Overview

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.

Study Details

The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. A cycle duration is 28 days. After study treatment discontinuation, participants will return to the study site 30 days after the last dose of study treatment for the EOT visit or before further anti-myeloma therapy initiation, whichever comes first.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Plasma Cell Myeloma Refractory
  • Age: 18 years or above
  • Gender: All

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.

Updated on 07 Apr 2025. Study ID: NCT06356571

This study investigates the effects of an investigational medication given with other treatments to adults with relapsed or refractory multiple myeloma (RRMM). Multiple myeloma is a cancer of the plasma cells in the bone marrow. The purpose of this study is to assess how well the investigational medication works when combined with two other treatments, carfilzomib and dexamethasone, given to patients who have already received 1 to 3 prior treatments for their condition.

Participants in the study will receive the investigational medication through a special device that delivers it under the skin. They will also receive carfilzomib and dexamethasone. After stopping the study treatment, participants will have a final visit to the study site 30 days after their last dose or before starting any new treatment for multiple myeloma.

  • Who can participate: Adults with a diagnosis of multiple myeloma who have received 1 to 3 prior treatments and have measurable disease can participate. Participants must not have had prior treatment with carfilzomib or anti-CD38 treatment within the last 6 months.
  • Study details: Participants will receive an investigational medication along with carfilzomib and dexamethasone. A placebo will not be used in this study.

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