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NCT03314181 · ClinicalTrials.gov registry record · Phase 2
A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by AbbVie.
- Active
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
- 20
- Study locations
NCT03314181: Active Phase 2 study of Multiple Myeloma, sponsored by AbbVie.
NCT03314181 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 156 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03314181, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
ORR is defined as the percentage of participants with documented partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Bortezomib
Study Locations (20)
North Carolina
- Atrium Health Carolinas Medical Center /ID# 164948 - Charlotte
- Duke Cancer Center /ID# 165104 - Durham
- Duplicate_Wake Forest Baptist Health /ID# 224447 - Winston-Salem
Victoria
- Eastern Health /ID# 165850 - Box Hill
- St Vincent's Hospital Melbourne /ID# 165853 - Fitzroy Melbourne
- Peter MacCallum Cancer Ctr /ID# 164742 - Melbourne
Massachusetts
- Beth Israel Deaconess Medical Center /ID# 210904 - Boston
- Dana-Farber Cancer Institute /ID# 166886 - Boston
New York
- Duplicate_Roswell Park Comprehensive Cancer Center /ID# 169615 - Buffalo
- Weill Cornell Medicine/NYP /ID# 167605 - New York
New South Wales
- The Kinghorn Cancer Centre /ID# 165431 - Darlinghurst
- St George Hospital /ID# 171063 - Kogarah
Colorado
- Univ of Colorado Cancer Center /ID# 167331 - Aurora
Florida
- Moffitt Cancer Center /ID# 169614 - Tampa
Georgia
- Winship Cancer Institute of Emory University /ID# 165427 - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2018-04-02 |
| Est. Completion | 2031-05 |
| Phase | Phase 2 |
What the registry record for NCT03314181 still lists
NCT03314181 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT03314181 names 20 study sites across 13 states, led by North Carolina, Victoria, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03314181 about?
NCT03314181 is a clinical study titled "A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma". 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...
What is the current status of trial NCT03314181?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2018-04-02. Estimated completion is 2031-05.
What conditions does trial NCT03314181 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03314181?
The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT03314181?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03314181 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03314181's enrollment target sits among peer trials
156 130th of 438 higher than 308 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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