A study to evaluate the safety and efficacy of study drug radium-223 dichloride when given in combination with bortezomib and dexamethasone in patients with multiple myeloma that has recurred

Registry ID
EUCTR2016-002438-58
Source registry
EUCTR
Status
Completed
Phase
PHASE2
Sponsor
Bayer AG
Start date
2016-11-16
Completion date
2019-03-20
Last update
2026-08-16

Conditions

Summary

Phase 1b part (open-label) 1. To evaluate the safety of the combination of radium-223 dichloride plus bortezomib and dexamethasone 2. To determine the dose of radium-223 dichloride that will be used in the phase 2 part of the study (recommended phase 2 dose [RP2D]) Phase 2 part (double-blind, randomized): 1. To compare radium-223 dichloride with placebo in addition to background treatment with bortezomib plus dexamethasone in terms of progression-free survival (PFS) in relapsed multiple myeloma subjects.

Locations

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