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ACTIVE NOT RECRUITING
NCT03314181
PHASE2

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: AbbVie

View on ClinicalTrials.gov

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

Interventions

DRUG

Dexamethasone

Infusion; Intravenous (IV), or Tablet; Oral

DRUG

Daratumumab

Injection; Subcutaneous (preferred), Infusion; Intravenous (IV)

DRUG

Venetoclax

Tablet; Oral

DRUG

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