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NCT02928029 · ClinicalTrials.gov registry record · Phase 1
Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02928029: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT02928029 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02928029, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
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 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. Up to 12 subjects in all dose cohorts combined will be treated in the phase 1b part of the study. Up to approximately 100 subjects will be enrolled in the phase 2 part of the study.
Primary Outcome
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Bortezomib
- DRUG Radium-223 dichloride (Xofigo, BAY88-8223)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2017-02-10 |
| Est. Completion | 2019-03-20 |
| Phase | Phase 1 |
Why NCT02928029 stopped before completion
NCT02928029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02928029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02928029 about?
NCT02928029 is a clinical study titled "Study Testing Radium-223 Dichloride in 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 is to determine the optimal d...
What is the current status of trial NCT02928029?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2017-02-10. Estimated completion is 2019-03-20.
What interventions are being tested in trial NCT02928029?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG), Radium-223 dichloride (Xofigo, BAY88-8223) (DRUG).
Who is sponsoring clinical trial NCT02928029?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02928029's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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