An Open-Label Phase 1/2 Study of the Safety and Efficacy of GCS-100 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
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
To evaluate GCS-100 related dose-limiting toxicity and to identify the maximum tolerated dose and/or the recommended dose for further studies.
Up to 12 consecutive 21-day treatment cycles
Robert Schlossman, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|University of Florida||Gainesville, Florida 32610-0277|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Froedtert & Medical College Clinics, Medical College of Wisconsin||Milwaukee, Wisconsin 53226|