A 24-week, Open-label Extension Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed Refractory Patients With Multiple Myeloma
The main objective of this study is to assess the long-term efficacy of SCIO-469 as
monotherapy, or in combination with bortezomib in relapsed, refractory patients with
multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003
study. Patients took by mouth two capsules (60 mg) three times a day alone or in combination
with bortezomib, for 168 days.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Baseline to Day 168
Scios, Inc. Clinical Trial
United States: Food and Drug Administration