Multiple Myeloma Clinical Trial
Official title:
A Phase 1b/2 Trial to Evaluate the Safety and Efficacy of Radium-223 Dichloride (BAY88-8223) in Combination With Bortezomib and Dexamethasone in Early Relapsed Multiple Myeloma
This study will be conducted in 2 parts. The phase 1b part will be an international, phase
1b, open-label, dose-escalation assessment of radium-223 dichloride administered with
bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary
endpoint of the phase 1b part is to determine the optimal dose of radium-223 dichloride in
combination with bortezomib/dexamethasone for the Phase 2 portion of the study.
The phase 2 part will be an international, phase 2, double-blind, randomized,
placebo-controlled assessment of radium-223 dichloride versus placebo administered with
bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization
(1:1) in the phase 2 part will be stratified by:
- Prior bortezomib treatment (yes, no)
- Prior treatment (1 prior line of treatment, >1 prior line of treatment) Approximately
30 subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study
and approximately 196 subjects will be enrolled in the phase 2 part of the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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