A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma (NCT03314181)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Univ of Colorado Cancer Center /ID# 167331 — Aurora, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- Univ of Colorado Cancer Center /ID# 167331 — Aurora, Colorado
- Moffitt Cancer Center /ID# 169614 — Tampa, Florida
- Winship Cancer Institute of Emory University /ID# 165427 — Atlanta, Georgia
- The University of Chicago Medical Center /ID# 165429 — Chicago, Illinois
- Beth Israel Deaconess Medical Center /ID# 210904 — Boston, Massachusetts
- Dana-Farber Cancer Institute /ID# 166886 — Boston, Massachusetts
- Hackensack Univ Med Ctr /ID# 225111 — Hackensack, New Jersey
- Duplicate_Roswell Park Comprehensive Cancer Center /ID# 169615 — Buffalo, New York
- Weill Cornell Medicine/NYP /ID# 167605 — New York, New York
- Atrium Health Carolinas Medical Center /ID# 164948 — Charlotte, North Carolina
- Duke Cancer Center /ID# 165104 — Durham, North Carolina
- Duplicate_Wake Forest Baptist Health /ID# 224447 — Winston-Salem, North Carolina
- Oregon Health and Science University /ID# 166822 — Portland, Oregon
- University of Washington /ID# 164884 — Seattle, Washington
- The Kinghorn Cancer Centre /ID# 165431 — Darlinghurst, New South Wales
- St George Hospital /ID# 171063 — Kogarah, New South Wales
- Duplicate_Royal Adelaide Hospital /ID# 171060 — Adelaide, South Australia
- Eastern Health /ID# 165850 — Box Hill, Victoria
- St Vincent's Hospital Melbourne /ID# 165853 — Fitzroy Melbourne, Victoria
- Peter MacCallum Cancer Ctr /ID# 164742 — Melbourne, Victoria
- Duplicate_Royal Perth Hospital /ID# 224895 — Perth, Western Australia
- Arthur J. E. Child Comprehensive Cancer Centre /ID# 167822 — Calgary, Alberta
- Cross Cancer Institute /ID# 203114 — Edmonton, Alberta
- Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 167824 — Montreal, Quebec
- Rigshospitalet /ID# 164420 — Copenhagen Ø, Capital Region
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Multiple Myeloma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.