Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma
Public ClinicalTrials.gov record NCT02605356. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02605356
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- Radium-223 dichloride (Xofigo, BAY88-8223) Drug
- Placebo Drug
- Bortezomib Drug
- Dexamethasone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2016 (Type not available)
- Primary completion
- Nov 2019 (Estimated)
- Completion
- Jul 2021 (Estimated)
- Last update posted
- Oct 7, 2016
2016 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Scottsdale | Arizona | 85259-5404 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Encinitas | California | 92024 | — |
| Not listed | Metairie | Louisiana | 70006 | — |
| Not listed | Rockville | Maryland | 20850-6535 | — |
| Not listed | New York | New York | 10032-3729 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Winston-Salem | North Carolina | 27157 | — |
| Not listed | Watertown | South Dakota | 57201 | — |
| Not listed | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02605356, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2016 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02605356 live on ClinicalTrials.gov.