Multiple Myeloma Clinical Trial
Official title:
An Open-Label Phase 1/2 Study of the Safety and Efficacy of GCS-100 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
A Phase 1, open-label, dose escalation, multi-center study in patients who have been diagnosed with multiple myeloma and who have relapsed or have refractory/relapsed disease after treatment with at least 2 prior therapies.
The primary objective of this study is to evaluate the safety and the dose-limiting
toxicities of GCS-100 in subjects with relapsed or relapsed/refractory multiple myeloma, and
to identify the maximum tolerated dose and/or the recommended dose for further studies.
The secondary objectives of this study are (i) to evaluate the safety of treatment with
GCS-100 in combination with bortezomib (VelcadeTM) in subjects whose disease has progressed
on GCS-100 alone; (ii) to evaluate the response to GCS-100 alone, in combination with
bortezomib in subjects whose disease has progressed on GCS-100 alone, and during
dexamethasone therapy in combination with GCS 100 plus bortezomib in subjects whose disease
has progressed on GCS-100 plus bortezomib; (iii) to evaluate the utility of potential
surrogate markers; (iv) to perform exploratory correlative analyses of bone marrow samples
to define better the mechanisms of action and response to therapy.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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