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Sponsor: Sanofi
Conditions: Plasma Cell Myeloma
Interventions: lenalidomide, bortezomib, cyclophosphamide, dexamethasone, isatuximab SAR650984
Countries: France, Germany, Italy, Spain
Primary Objectives: * VCDI cohort: * To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation * To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria. * VRDI Part A cohort and Part B cohort: * To evaluate the preliminary efficacy (complete response \[CR\] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation or no intent for immediate transplantation. Secondary Objectives: * VCDI cohort: * To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities. * To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen. * To evaluate the immunogenicity of SAR650984 in combination treatments. * To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival. * To assess the relationship between clinical effects (adverse event \[AE\] and/or tumor response) and CD38 receptor density. * VRDI Part A cohort and Part B cohort: * To characterize the overall safety profile of isatuximab in combination with VRD regimen. * To evaluate the infusion duration (only applicable for VRDI Part B cohort) * To characterize the PK profile of isatuximab and each combination drug in VRDI regimen. * To evaluate the immunogenicity of isatuximab in combination treatments. * To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS. * To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment. * To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort). * To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * Newly diagnosed patients with measurable multiple myeloma defined as at least one of the following: * Serum M protein ≥1 g/dL (≥10 g/L). * Urine M protein ≥200 mg/24 hours. * Serum free light chain (sFLC) assay: involved free light chain assay ≥10 mg/dL (≥100 mg/L) and an abnormal sFLC ratio (\<0.26 or \>1.65). * Patients with ultra-high risk smoldering multiple myeloma fulfilling the International Myeloma Working Group criteria are eligible. * Patient is not eligible for transplant. * Patient with no intent for immediate transplant as per investigator's decision are also eligible for VRDI Part B cohort only. Exclusion criteria: * Eastern Cooperative Oncology Group performance status \>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.
- Nantes, France
- Pierre-Bénite, France
- Toulouse, France
- Berlin, Germany
- Leipzig, Germany
- Milan, Italy
- Roma, Italy
- Torino, Italy
- Santander, Cantabria, Spain
- Pamplona, Navarre, Spain
- Madrid, Spain
- Salamanca, Spain