Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
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 people with multiple myeloma
Eligibility
Inclusion
Participants must have a documented diagnosis of multiple myeloma (MM)
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 treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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)
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