Multiple Myeloma Clinical Trial

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

Summary

Primary Objectives:

To evaluate the safety and tolerability of the combination of treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

109

Study ID:

NCT03194867

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 30 Locations for this study

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University of Colorado-Site Number:8400001
Denver Colorado, 80262, United States
University of Kansas Medical Center-Site Number:8400003
Kansas City Kansas, 66160, United States
Memorial Sloan-Kettering Cancer Center-Site Number:8400002
New York New York, 10021, United States
Fox Chase Cancer Center-Site Number:8400004
Philadelphia Pennsylvania, 19111, United States
Investigational Site Number :0360003
Wollongong New South Wales, 2500, Australia
Investigational Site Number :0360002
Richmond Victoria, 3121, Australia
Investigational Site Number :0360001
West Perth Western Australia, 6005, Australia
Investigational Site Number :0760003
Goiania Goiás, 74605, Brazil
Investigational Site Number :0760001
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Investigational Site Number :0760004
Sao Paulo São Paulo, 01236, Brazil
Investigational Site Number :1240001
Montreal Quebec, H1T 2, Canada
Investigational Site Number :1240005
Montreal Quebec, H4J 1, Canada
Investigational Site Number :1240003
Sherbrooke Quebec, J1H 5, Canada
Investigational Site Number :2030002
Brno , 62500, Czechia
Investigational Site Number :2030003
Ostrava - Poruba , 70852, Czechia
Investigational Site Number :2030001
Praha 2 , 12808, Czechia
Investigational Site Number :2500004
Lille , 59037, France
Investigational Site Number :2500002
Nantes , 44093, France
Investigational Site Number :2500003
Pierre Benite , 69495, France
Investigational Site Number :2500001
Villejuif , 94800, France
Investigational Site Number :3000001
Athens , 11528, Greece
Investigational Site Number :3480002
Budapest , 1083, Hungary
Investigational Site Number :3800005
Rozzano Milano, 20089, Italy
Investigational Site Number :3800003
Brescia , 25123, Italy
Investigational Site Number :3800001
Torino , 10126, Italy
Investigational Site Number :7240003
Barcelona Barcelona [Barcelona], 08035, Spain
Investigational Site Number :7240004
Badalona Catalunya [Cataluña], 08916, Spain
Investigational Site Number :7240002
Barcelona Catalunya [Cataluña], 08036, Spain
Investigational Site Number :7240005
Valencia Valenciana, Comunidad, 46017, Spain
Investigational Site Number :7240006
Madrid , 28041, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

109

Study ID:

NCT03194867

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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