Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

The duration of the study for the patients will include a period for screening of up to 3
weeks. Patients will continue study treatment until disease progression, unacceptable adverse
reaction, patients' wish or other reason of discontinuation. During follow-up, patients who
discontinue the study treatment due to progression of the disease will be followed every 3
months (12 weeks) for further anti-myeloma therapies, progression free survival to the second
progression and survival, until death or the cut-off date, whichever comes first. Patients
who discontinue the study treatment prior to documentation of disease progression will be
followed-up every 4 weeks until confirmation of disease progression, and then every 3 months
(12 weeks) for further anti-myeloma therapies, progression free survival to the second
progression and survival, until death or the cut-off date, whichever comes first. After
progression free survival analysis, patients will be followed yearly for 3 years for
survival.

Inclusion criteria:

- Patients with multiple myeloma previously treated with prior 1 to 3 lines and with
measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours).

Exclusion criteria:

- Patients previously pretreated with carfilzomib, who never achieved at least one minor
response during previous therapies and/or last previous therapy completed within 14
last days.

- Patients with serum free light chain (FLC) measurable disease only.

- Patients less than 18 years old, patients with Eastern Cooperative Oncology Group
performance status more than 2.

- Patients with inadequate biological tests.

- Patients with myocardial infarction, severe/unstable angina pectoris,
coronary/peripheral artery bypass graft, New York Heart Association class III or IV
congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or
transient ischemic attack within last 6 months, and/or left ventricular ejection
fraction lower than 40%.

- Patients with previous cancer unless disease free for more than 5 years or in situ
cancer curatively treated.

- Patients with known acquired immunodeficiency syndrome related illness (AIDS) or human
immunodeficiency virus (HIV) requiring antiretroviral treatment, or hepatitis A, B, or
C active infection.

- Women of childbearing potential or male patient with women of childbearing potential
who do not agree to use highly effective method of birth control.

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