Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients



Status:Recruiting
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:February 21, 2018
End Date:March 2021
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-Us@sanofi.com
Phone:800-633-1610

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A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma

Primary Objectives:

- To evaluate the safety and tolerability of the combination of isatuximab (also known as
SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory
multiple myeloma.

- To compare the overall response of the combination of isatuximab and cemiplimab versus
isatuximab alone in patients with RRMM based on International Myeloma Working Group
(IMWG) criteria.

Secondary Objectives:

- To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of
response (DOR), time to response (TTR), progression free survival (PFS), and overall
survival (OS).

- To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in
combination.

- To assess the immunogenicity of isatuximab and cemiplimab when given in combination.

The duration of the study for a patient will include a period for screening of up to 21 days
and 3-month post treatment follow up. The cycle duration is 28 days. Patients will continue
treatment until disease progression, unacceptable adverse events, consent withdrawal, or any
other reason.

Inclusion criteria:

- Patients must have a known diagnosis of multiple myeloma with evidence of measurable
disease, as defined below:

- Serum M-protein ≥1 g/dL (≥0.5 g/dL in case of immunoglobulin A [IgA] disease),
AND/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
(<0.26 or >1.65).

- Patients must have received prior treatment with an immunomodulatory drug (IMiD) (for
≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (PI) (for ≥2 cycles or
≥2 months of treatment).

- Patients must have received at least 3 prior lines of therapy (Note: Induction therapy
and stem cell transplant ± maintenance will be considered as one line).

- Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary
refractory disease is not eligible).

Exclusion criteria:

- Prior exposure to isatuximab or participated clinical studies with isatuximab.

- Prior exposure to any agent (approved or investigational) that blocks the programmed
cell death-1 (PD-1)/PD-L1 pathway.

- Evidence of other immune related disease/conditions.

- History of non-infectious pneumonitis requiring steroids or current pneumonitis;
history of the thoracic radiation.

- Has received a live-virus vaccination within 30 days of planned treatment start.
Seasonal flu vaccines that do not contain live virus are permitted.

- Has allogenic haemopoietic stem cell (HSC) transplant.

- Prior treatment with idelalisib (a PI3K inhibitor).

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

- Poor bone marrow reserve.

- Poor organ function.

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