SAR650984, Pomalidomide 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. The treatment period may continue until disease progression, unacceptable
adverse reaction, or other reason for discontinuation. After study treatment discontinuation
an end of treatment (EOT) visit will be done at approximately 30 days after last study
treatment component administration to assess safety. If the last ADA sample is positive or
inconclusive, additional ADA will be sampled 3 months later. No further ADA will be sampled,
even if this 3-month sample is positive. Patients who discontinue treatment for reasons other
than progression of disease will be followed every month until progression or initiation of
subsequent therapy, for a maximum of one year, whichever comes first.

Inclusion criteria :

- Patient has been previously diagnosed with multiple myeloma (MM) based on standard
criteria and currently requires treatment because MM has relapsed following a
response, according to International Myeloma Working Group (IMWG) criteria.

- Patient had received at least two previous therapies including lenalidomide and
proteasome inhibitor and have demonstrated disease progression on therapy or after
completion of the last therapy.

- Patients with measurable disease defined as at least one of the following:

- Serum M protein ≥0.5 g/dL (≥5 g/L);

- Urine M protein ≥200 mg/24 hours;

- 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).

Exclusion criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status >2.

- Poor bone marrow reserve.

- Poor organ function.

- Known intolerance/hypersensitivity to IMiDs, dexamethasone, boron or mannitol,
sucrose, histidine or polysorbate 80.

- Any serious active disease (including clinically significant infection that is
chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the
Investigator, could interfere with the safety, the compliance with the study or with
the interpretation of the results.

- Any severe underlying medical conditions including presence of laboratory
abnormalities, which could impair the ability to participate in the study or the
interpretation of its results.

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