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Sponsor: Sanofi
Conditions: Plasma Cell Myeloma
Interventions: Isatuximab SAR650984, Cemiplimab REGN2810
Countries: United States, Australia, Brazil, Canada, Czechia, France, Greece, Hungary
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Denver, Colorado, United States
- Kansas City, Kansas, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Wollongong, New South Wales, Australia
- Richmond, Victoria, Australia
- West Perth, Western Australia, Australia
- Goiânia, Goiás, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Montreal, Quebec, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Brno, Czechia
- Ostrava - Poruba, Czechia
- Prague, Czechia
- Lille, France
- Nantes, France
- Pierre-Bénite, France
- Villejuif, France
- Athens, Greece
- Budapest, Hungary
- Rozzano, Milano, Italy
- Brescia, Italy
- Torino, Italy
- Barcelona, Barcelona [Barcelona], Spain
- Badalona, Catalunya [Cataluña], Spain
- Barcelona, Catalunya [Cataluña], Spain
- Valencia, Valenciana, Comunidad, Spain
- Madrid, Spain