SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients

The study duration for an individual patient will include a screening period for inclusion of
up to 21 days, and at least 4 weeks of treatment in the absence of severe adverse reaction,
dose limiting toxicity or disease progression plus up to 60 days post-treatment follow up.
The treatment period may continue until disease progression, intolerable toxicity, or
Investigator, sponsor, or patient decision to discontinue therapy. After study treatment
discontinuation, an end of treatment (EOT) visit will be done at 30 days to assess safety,
and at 30 and 60 days for anti-drug antibody (ADA) and PK. If the ADA is positive or
inconclusive at day 60, then PK and ADA will be repeated every 30 days until ADA is negative.
Patients who discontinue treatment for reasons other than progression of disease will be
followed monthly until progression, initiation of subsequent therapy, or until the primary
analysis cutoff date, whichever comes first.

Inclusion criteria:

Male or female patients age 18 years or older. Diagnosis of multiple myeloma and
documentation of at least 2 prior therapies (induction therapy, autologous stem cell
transplant, consolidation and maintenance therapy is considered one prior therapy); there
is no maximum number of prior regimens and prior bone marrow transplant is acceptable.

Confirmed evidence of disease progression from immediately prior MM therapy or refractory
to the immediately prior therapy.

Patients may have received prior immunomodulatory drugs (IMiDs®) (eg, lenalidomide or
thalidomide).

Patients with measurable disease. Patients with a Karnofsky ≥60% performance status.
Females of childbearing potential (FCBP). Voluntary written informed consent before
performance of any study-related procedure not part of routine medical care with the
understanding that consent may be withdrawn by the subject at any time without prejudice to
future medical care.

Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (in accordance with
national and local subject privacy regulations).

Able to take aspirin daily as prophylactic anti-coagulation therapy (patients intolerant to
aspirin may use warfarin, low molecular weight heparin or equivalent anti-platelet
therapy).

Adequate organ function.

Exclusion criteria:

Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the
skin, an in situ malignancy, or low risk prostate cancer after curative therapy.

Prior anti-cancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy)
within 21 days except for alkylating agents (eg, melphalan) where 28 days will be required
or participated in another clinical trial during the past 30 days.

History of significant cardiovascular disease within the past 6 months, unless the disease
is well-controlled.

Prior autologous stem cell transplant within 12 weeks of the first dose of study treatment
and/or prior allogeneic transplant within 1 year or has evidence of active
graft-versus-host disease (GVHD) requiring >10 mg prednisone daily.

Daily requirement for corticosteroids (>10 mg prednisone qd for 7 consecutive days) (except
for inhalation corticosteroids and patients being treated for adrenal
insufficiency/replacement therapy).

Evidence of mucosal or internal bleeding. Prior radiation therapy or major surgical
procedure within 4 weeks of the first dose of study treatment.

Known active infection requiring parenteral or oral anti-infective treatment. Serious
psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse
follow-up evaluation.

Any medical conditions that, in the Investigator's opinion, would impose excessive risk to
the patient.

Hypersensitivity to any of the components of study therapy that is not amenable to
premedication with steroids and H2 blockers.

Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.

Neuropathy ≥ Grade 3 or painful neuropathy ≥ Grade 2. Gastro-intestinal abnormalities,
including bowel obstruction, inability to take oral medication, requirement for intravenous
(IV) alimentation, active peptic ulcer or prior surgical procedures or bowel resection
affecting absorption.

Pregnancy.

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