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

Launched by SANOFI · Jan 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for adults with relapsed or refractory multiple myeloma (RRMM), which means their cancer has returned or has not responded to previous treatments. The study is testing a combination of three medications: isatuximab (given under the skin), carfilzomib, and dexamethasone. The goal is to see how well this combination works at helping patients respond to treatment after they have already tried one to three other therapies.

To participate in this trial, individuals must have a confirmed diagnosis of multiple myeloma and have measurable disease. This means their condition can be tracked through certain tests. Eligible participants should have had at least one prior treatment for their cancer but no more than three. Women who can become pregnant need to either agree to use birth control or practice complete abstinence, while men must also use approved contraception during the study and for some time after it ends. Participants will receive the new treatment and will be monitored for its effects. It’s important to note that this study is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.