International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Inclusion Criteria:

• Participant must be ≥18 years of age (or the legal age of consent in thejurisdiction in which the study is taking place), at the time of signing theinformed consent.

• Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximabmonotherapy or in a combination regimen with all the study objectives completed.

• Participants still receiving isatuximab at the time of the parental study closure,who are continuing to benefit from isatuximab as monotherapy or in combination, asdetermined by the treating physician, and who meet the criteria to initiate asubsequent cycle of therapy as described in the parental study protocol. Aparticipant not receiving isatuximab at the end of the parental study who does nothave access locally to the ongoing treatment may also be included.

• Contraception (with double contraception methods) for male and female participants;not pregnant or breastfeeding for female participants; no sperm donation for maleparticipants.

• Capable of giving signed informed consent.

Exclusion Criteria:

• Participant has evidence of progressive disease during or at the time of theparental study closure.

• Participant has not recovered to ≤Grade 2 from nonhematologic AEs (as per NCI CTCAEv5.0) related to any anticancer therapy received prior to signing informed consenton the extension study.

• As the latest line of treatment participant received an antimyeloma therapy otherthan the isatuximab-based therapy in the parental study before the first IMP in thisstudy.

• Individuals accommodated in an institution because of regulatory or legal order;prisoners or participants who are legally institutionalized.

• 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.

• Participants are employees of the clinical study site or other individuals directlyinvolved in the conduct of the study, or immediate family members of suchindividuals.

• Any country-related specific regulation that would prevent the participant fromentering the study.

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