Found 6 clinical trials
Safety Pharmacokinetics and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
To evaluate the immunogenicity of isatuximab. To assess the overall efficacy of isatuximab in desensitization of patients awaiting kidney transplantation.
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- 19 Feb, 2024
- 2 locations
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Primary Objectives: Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to …
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- 19 Feb, 2024
- 16 locations
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Primary Objectives: Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to …
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- 19 Feb, 2024
- 11 locations
Multi-center Open-label Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Primary Objectives: To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: To estimate absolute bioavailability of SC and IV isatuximab To measure receptor occupancy (RO) after isatuximab SC versus IV administration To assess …
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- 19 Feb, 2024
- 13 locations
A Prospective Non-interventional Multinational Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to …
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- 19 Feb, 2024
- 4 locations
A Prospective Non-interventional Multinational Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to …
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- 19 Feb, 2024
- 10 locations