Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
Status:
Active, not recruiting
Trial end date:
2022-10-11
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with
relapsed and refractory multiple myeloma.
- Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate
the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and
refractory multiple myeloma.
Secondary Objectives:
- To evaluate the safety including immunogenicity of isatuximab. The severity, frequency
and incidence of all adverse events will be assessed.
- To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing
schedule.
- To assess the efficacy using International Myeloma Working Group (IMWG) uniform response
criteria.
- To assess the relationship between baseline CD38 receptor density on multiple myeloma
cells and efficacy.