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

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 immunoelectrophoresisand/or

• Urine M-protein ≥200 mg/24 hours measured using urine proteinimmunoelectrophoresis 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 oftherapy and no more than 3 prior lines of therapy.

• Contraceptive use by [men and women] should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

• Male participants agree to practice true abstinence or agree to usecontraception while receiving study treatment, during dose interruptions and atleast 5 months following study treatment discontinuation, even if has undergonea successful vasectomy.

• A female participant is eligible to participate if she is not pregnant, notbreastfeeding, and either is not a female of childbearing potential (FCBP XE "FCBP " \f Abbreviation \t "female of childbearing potential" ) or agrees topractice 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 aminimal response (MR) with any treatment during the disease course.

• Participants with prior anti-CD38 treatment if: a) administered < 6 months beforefirst isatuximab administration or, b) intolerant to the anti-CD38 previouslyreceived.

• Participants who are refractory to carfilzomib.

• Known history of allergy to captisol (a cyclodextrin derivative used to solubilizecarfilzomib), prior hypersensitivity to sucrose, histidine (as base andhydrochloride salt), polysorbate 80, or any of the components (active substance orexcipient) of study treatment that are not amenable to premedication with steroids,or intolerance to arginine and Poloxamer 188 that would prohibit further treatmentwith these agents.

• Participants with contraindication to dexamethasone and/or to carfilzomib.

• Any anti-myeloma drug treatment within 14 days before the first isatuximabadministration, 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 beingunder 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 isatuximabadministration. Seasonal flu vaccines that do not contain live virus are permitted.

• Participant not suitable for participation, whatever the reason, as judged by theInvestigator, including medical or clinical conditions, or participants potentiallyat 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.