A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

Inclusion criteria:

- Male or female patients age 18 years or older.

- Diagnosis of multiple myeloma & documentation of at least 2 prior therapies
(induction therapy is considered one prior therapy); there is no maximum number of
prior regimens & 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not part of routine medical care with the understanding that consent may be withdrawn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 & provide signed & dated
informed consent & authorization to use protected health information (in accordance
with national & 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, &
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 peripheral stem cell transplant within 12 weeks of the first dose of study
treatment.

- Daily requirement for corticosteroids (>10 mg/kg prednisone qd) (except for
inhalation corticosteroids).

- 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.