Spots Global Cancer Trial Database for A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma
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
Study ID: NCT03314181
Conditions
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Univ of Colorado Cancer Center /ID# 167331, Aurora, Colorado, United States
Moffitt Cancer Center /ID# 169614, Tampa, Florida, United States
Emory University, Winship Cancer Institute /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
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
Wake Forest Baptist Health /ID# 224447, Winston-Salem, North Carolina, United States
Oregon Health & 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
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
Royal Perth Hospital /ID# 224895, Perth, Western Australia, Australia
Tom Baker Cancer Centre /ID# 167822, Calgary, Alberta, Canada
Cross Cancer Institute /ID# 203114, Edmonton, Alberta, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 167824, Montreal, Quebec, Canada
Rigshospitalet /ID# 164420, Copenhagen Ø, Hovedstaden, Denmark
Aarhus University Hospital /ID# 164509, Aarhus N, Midtjylland, Denmark
Odense University Hospital /ID# 164417, Odense C, Syddanmark, Denmark
Sygehus Lillebælt, Vejle /ID# 164418, Vejle, Syddanmark, Denmark
CHU Limoges - Dupuytren 1 /ID# 224759, Limoges CEDEX 1, Franche-Comte, France
CHRU Tours - Hopital Bretonneau /ID# 164795, Tours CEDEX 9, Indre-et-Loire, France
CHU de Nantes, Hotel Dieu -HME /ID# 164767, Nantes, Pays-de-la-Loire, France
CHU Poitiers - La milétrie /ID# 164806, Poitiers, Poitou-Charentes, France
Institut Gustave Roussy /ID# 164807, Villejuif Cedex, Val-de-Marne, France
AP-HP - Hopital Saint-Louis /ID# 224758, Paris, , France
Universitaetsklinikum Freiburg /ID# 166036, Freiburg, Baden-Wuerttemberg, Germany
University Hospital Cologne /ID# 166037, Cologne, , Germany
Nagoya City University Hospital /ID# 225273, Nagoya shi, Aichi, Japan
Kameda General Hospital /ID# 225246, Kamogawa-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 225196, Matsuyama-shi, Ehime, Japan
Gifu Municipal Hospital /ID# 240381, Gifu-shi, Gifu, Japan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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