Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
Clareo Health | Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
