Study duration for an individual patient will include a screening period for inclusion of up
to 3 weeks, the treatment period and, a follow up period. Treatment with SAR650984
(isatuximab) may continue until disease progression, unacceptable adverse event, or other
reason for discontinuation.
After study treatment discontinuation, an end of treatment visit will be done at 30 days to
assess safety and PK, and at 30 and 60 days for anti-drug antibody (ADA). If the ADA is
positive at Day 60, ADA will be repeated every 30 days until ADA is negative.
Patients with partial remission or better who discontinue treatment for reasons other than
progression of disease will be followed monthly until progression or initiation of subsequent
therapy, the final analysis cutoff date, whichever comes first.
Inclusion criteria:
Part A
- Patients must have a known diagnosis of multiple myeloma (MM) with evidence of
measurable disease, as defined below, and have evidence of disease progression based
on International Myeloma Working Group (IMWG) criteria:
- Serum M-protein ≥1g/dL, or urine M-protein ≥200 mg/24 hours, OR
- In the absence of measurable M-protein, serum immunoglobulin free light chain ≥10
mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Patients must have received at least 3 prior lines of therapy for MM and must include
treatment with an immunomodulatory drug (IMiD) (for ≥2 cycles or ≥2 months of
treatment) and a proteasome inhibitor (for ≥2 cycles or ≥2 months of treatment).
Induction therapy and stem cell transplant (± maintenance) will be considered as one
regimen within a line, OR
- Patients whose disease is double refractory to an IMiD and a proteasome inhibitor. For
patients who have received more than one type of IMiD and proteasome inhibitor, their
disease must be refractory to the most recent one.
- Patients must have achieved a minimal response (MR) or better to at least one prior
line of therapy.
- Patients must have received an alkylating agent (for ≥2 cycles or ≥2 months of
treatment) either alone or in combination with other MM treatments (history of stem
cell transplant is acceptable). Treatment with high-dose Melphalan for stem cell
transplantation meets this requirement.
- Signed written informed consent and be willing and able to complete all study-related
procedures.
Part B
- Patients must have a known diagnosis of multiple myeloma (MM) with evidence of
measurable disease, as defined below, and have evidence of disease progression based
on International Myeloma Working Group (IMWG) criteria:
- Serum M-protein ≥1g/dL, or urine M-protein ≥200 mg/24 hours, OR
- In the absence of measurable M-protein, serum immunoglobulin free light chain ≥10
mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Patients must have received at least 3 cycles of daratumumab treatment with at least 6
weeks from the last treatment with daratumumab to the first study treatment OR at
least 2 cycles of daratumumab treatment in case another therapy is given between
daratumumab and isatuximab with at least 12 weeks from the last treatment with
daratumumab to the first study treatment.
- Patients must have achieved MR or better to at least 1 prior line of therapy.
- Signed written informed consent and be willing and able to complete all study-related
procedures.
Exclusion criteria:
- Patients <18 years old.
- 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 comorbid 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.
