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RecruitingLast updated: 8 January 2024

This study aims to measure the success administering a drug called isatuximab as a subcutaneous injection, when given in combination with other drugs, in people with relapsed or refractory multiple myeloma who have received prior treatmentA Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Clinical summary

Summary

This study has two parts. 

Part 1 aims to establish the feasability of administering the drug isatuximab as a subcutaneous injection, and has two cohorts:

  • Cohort 1: Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter. Carfilzomib and dexamethasone will also be given.
  • Cohort 2: Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter. Carfilzomib and Dexamethasone will also be given.

Part 2 is further evaluating the delivery methods of isatuximab in combation with carfilzomib and dexamethasone, and has two cohorts:

  • OBDS to manual cohort: Isatuximab will be administered via OBDS from Cycle 1 to Cycle 3. For Cycle 4 to 6, the method of administration will be switched for each participation from OBDS to manual administration. Carfilzomib and Dexamethasone will also be given.
  • Manual to OBDS cohort: Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. Carfilzomib and Dexamethasone will also be given.

Conditions

This trial is treating patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Sanofi

Scientific Title

A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Eligibility

Inclusion

Participants must have a documented diagnosis of multiple myeloma (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).
  • Participant with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees to practice complete abstinence or use approved contraception methods.
  • Male participants agree to practice true abstinence or agree to use approved contraception methods while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.
  • Capable of giving signed informed consent.

Exclusion

  • 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 <9 months before first isatuximab administration or randomization as applicable or, b) Intolerant to the anti-CD38 previously received
  • Prior treatment with 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
  • Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain (AL) amyloidosis
  • Any severe acute or chronic medical condition which could impair the ability of the participant to participate in the study or interfere with interpretation of study results (eg, systemic infection unless specific anti-infective therapy is employed) or participant unable to comply with the study procedures.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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