A Phase 1/2 interventional study of Radium-223 dichloride (Xofigo, BAY88-8223) and Placebo in Multiple Myeloma, sponsored by Bayer. Withdrawn at 58 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-07.
Sponsored by Bayer · Phase 1/2, Interventional, and Treatment
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:
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
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Subjects must have measurable disease defined as at least 1 of the following (according to central laboratory results):
Exclusion Criteria:
Phase 1: Radium-223 dichloride; 30 kiloBecquerel (kBq)/kg body weight (33 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) every 4 weeks for a total of 6 radium-223 dichloride doses plus SOC bortezomib/dexamethasone.
Drug: Radium-223 dichloride (Xofigo, BAY88-8223) · Drug: Bortezomib · Drug: Dexamethasone
Phase 1: Radium-223 dichloride; 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) every 4 weeks for a total of 6 radium-223 dichloride doses plus SOC bortezomib/dexamethasone.
Drug: Radium-223 dichloride (Xofigo, BAY88-8223) · Drug: Bortezomib · Drug: Dexamethasone
Phase 1: Radium-223 dichloride; 80 kBq/kg body weight (88 kBq/kg after implementation of NIST update) every 4 weeks for a total of 6 radium-223 dichloride doses plus SOC bortezomib/dexamethasone.
Drug: Radium-223 dichloride (Xofigo, BAY88-8223) · Drug: Bortezomib · Drug: Dexamethasone
Phase 2: Matching placebo (isotonic saline) every 4 weeks for a total of 6 doses plus SoC (Standard of care) bortezomib/dexamethasone.
Drug: Placebo · Drug: Bortezomib · Drug: Dexamethasone
Phase 2: Phase 1b-selected dose of radium-223 dichloride every 4 weeks for 6 doses plus SOC bortezomib/dexamethasone
Drug: Radium-223 dichloride (Xofigo, BAY88-8223) · Drug: Bortezomib · Drug: Dexamethasone
Joint positive adjudication of safety summary in Phase 1b by steering committee, investigator and sponsor (Yes/No)
Time frame: At 13 months
Progression-free survival (PFS) in Phase 2, defined as the time (in days) from date of randomization to disease progression
Time frame: Up to 25 months
Objective response rate (ORR) in Phase 1b, in the proportion of subjects in the analysis population who have complete response (CR), stringent complete response (sCR), very good partial response (VGPR), partial response (PR), or stable disease (SD)
Time frame: Approximately 12 months
Duration of response in Phase 1b, defined as the time (in days) from the date of first response to treatment (CR, sCR, VGPR, PR) to the date of disease progression or death
Time frame: Approximately 12 months
Number of participants with adverse events in phase 2
Time frame: Up to 25 months
Overall survival (OS) in Phase 2, defined as the time (in days) from date of randomization until death from any cause
Time frame: Up to 25 months
Time to Symptomatic Skeletal Event (SSE) in Phase 2, defined as the time (days) from the date of randomization to the date of the first on-study SSE
Time frame: Up to 25 months
Symptomatic skeletal event free survival in Phase 2, defined as the time from randomization to the occurrence of 1 of the following: First on-study SSE or Death from any cause if death occurs before a documented SSE
Time frame: Up to 25 months
Time to pain progression in Phase 2
Time frame: Up to 25 months
Duration of response in Phase 2
Time frame: Up to 25 months
Objective Response Rate (ORR) in Phase 2
Time frame: Up to 25 months
This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Radium Ra 223 dichloride