Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: AbbVie
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2018-04-02
Completion Date
2031-05
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone
Infusion; Intravenous (IV), or Tablet; Oral
Daratumumab
Injection; Subcutaneous (preferred), Infusion; Intravenous (IV)
Venetoclax
Tablet; Oral
Bortezomib
Injection; Subcutaneous (preferred), Infusion; Intravenous (IV)
Locations (40)
Univ of Colorado Cancer Center /ID# 167331
Aurora, Colorado, United States
Moffitt Cancer Center /ID# 169614
Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 165427
Atlanta, Georgia, United States
The University of Chicago Medical Center /ID# 165429
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center /ID# 210904
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 166886
Boston, Massachusetts, United States
Hackensack Univ Med Ctr /ID# 225111
Hackensack, New Jersey, United States
Duplicate_Roswell Park Comprehensive Cancer Center /ID# 169615
Buffalo, New York, United States
Weill Cornell Medicine/NYP /ID# 167605
New York, New York, United States
Atrium Health Carolinas Medical Center /ID# 164948
Charlotte, North Carolina, United States
Duke Cancer Center /ID# 165104
Durham, North Carolina, United States
Duplicate_Wake Forest Baptist Health /ID# 224447
Winston-Salem, North Carolina, United States
Oregon Health and Science University /ID# 166822
Portland, Oregon, United States
University of Washington /ID# 164884
Seattle, Washington, United States
The Kinghorn Cancer Centre /ID# 165431
Darlinghurst, New South Wales, Australia
St George Hospital /ID# 171063
Kogarah, New South Wales, Australia
Duplicate_Royal Adelaide Hospital /ID# 171060
Adelaide, South Australia, Australia
Eastern Health /ID# 165850
Box Hill, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 165853
Fitzroy Melbourne, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 164742
Melbourne, Victoria, Australia
Duplicate_Royal Perth Hospital /ID# 224895
Perth, Western Australia, Australia
Arthur J. E. Child Comprehensive Cancer Centre /ID# 167822
Calgary, Alberta, Canada
Cross Cancer Institute /ID# 203114
Edmonton, Alberta, Canada
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 167824
Montreal, Quebec, Canada
Rigshospitalet /ID# 164420
Copenhagen Ø, Capital Region, Denmark
Duplicate_Aarhus University Hospital /ID# 164509
Aarhus N, Central Jutland, Denmark
Odense University Hospital /ID# 164417
Odense, Region Syddanmark, Denmark
Sygehus Lillebalt, Vejle /ID# 164418
Vejle, Region Syddanmark, Denmark
CHU Limoges - Dupuytren 1 /ID# 224759
Limoges, Franche-Comte, France
CHRU Tours - Hopital Bretonneau /ID# 164795
Tours, Indre-et-Loire, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 164767
Nantes, Pays de la Loire Region, France
Institut Gustave Roussy /ID# 164807
Villejuif, Val-de-Marne, France
CHU Poitiers - La miletrie /ID# 164806
Poitiers, Vienne, France
Duplicate_AP-HP - Hopital Saint-Louis /ID# 224758
Paris, France
Universitaetsklinikum Freiburg /ID# 166036
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University Hospital Cologne /ID# 166037
Cologne, North Rhine-Westphalia, Germany
Nagoya City University Hospital /ID# 225273
Nagoya, Aichi-ken, Japan
Kameda General Hospital /ID# 225246
Kamogawa-shi, Chiba, Japan
Duplicate_Matsuyama Red Cross Hospital /ID# 225196
Matsuyama, Ehime, Japan
Gifu Municipal Hospital /ID# 240381
Gifu, Gifu, Japan