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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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