A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma
Public ClinicalTrials.gov record NCT03314181. 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 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd). Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).
Study identification
- NCT ID
- NCT03314181
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 156 participants
Conditions and interventions
Conditions
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
- Apr 2, 2018 (Actual)
- Primary completion
- May 2031 (Estimated)
- Completion
- May 2031 (Estimated)
- Last update posted
- Aug 14, 2025
2018 – 2031
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Colorado Cancer Center /ID# 167331 | Aurora | Colorado | 80045 | — |
| Moffitt Cancer Center /ID# 169614 | Tampa | Florida | 33612-9416 | — |
| Winship Cancer Institute of Emory University /ID# 165427 | Atlanta | Georgia | 30322 | — |
| The University of Chicago Medical Center /ID# 165429 | Chicago | Illinois | 60637-1443 | — |
| Beth Israel Deaconess Medical Center /ID# 210904 | Boston | Massachusetts | 02215-5400 | — |
| Dana-Farber Cancer Institute /ID# 166886 | Boston | Massachusetts | 02215 | — |
| Hackensack Univ Med Ctr /ID# 225111 | Hackensack | New Jersey | 07601 | — |
| Duplicate_Roswell Park Comprehensive Cancer Center /ID# 169615 | Buffalo | New York | 14263 | — |
| Weill Cornell Medicine/NYP /ID# 167605 | New York | New York | 10021-4872 | — |
| Atrium Health Carolinas Medical Center /ID# 164948 | Charlotte | North Carolina | 28203 | — |
| Duke Cancer Center /ID# 165104 | Durham | North Carolina | 27710-3000 | — |
| Duplicate_Wake Forest Baptist Health /ID# 224447 | Winston-Salem | North Carolina | 27157-0001 | — |
| Oregon Health and Science University /ID# 166822 | Portland | Oregon | 97239 | — |
| University of Washington /ID# 164884 | Seattle | Washington | 98109 | — |
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 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03314181, 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 Aug 14, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03314181 live on ClinicalTrials.gov.