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

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.