NCT03314181: Phase 2 - Venetoclax, Daratumumab and Dex (+/- Bortezomib) in RRMM Multiple Myeloma

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

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).

Sponsor

AbbVie

Collaborator

Janssen Research & Development, LLC

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ClinicalTrials.gov Identifier: NCT03314181

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

First Posted : October 19, 2017

Click here for details on ClinicalTrials.gov

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Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Pomalidomide: National Cancer Institute

Pomalidomide: MedlinePlus Drug Information

Venetoclax : National Cancer Institute

Venetoclax : MedlinePlus Drug Information

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Drug: Dexamethasone

Drug: Daratumumab

Drug: Venetoclax

Drug: Bortezomib

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Multiple location

International Study

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Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14)

J Clin Oncol; 2021

https://pubmed.ncbi.nlm.nih.gov/34388020/

652.Multiple Myeloma and Plasma cell Dyscrasias: Clinical and Epidemiological| November 5, 2021

Safety and Preliminary Efficacy from the Expansion Cohort of a Phase 1/2 Study of Venetoclax Plus Daratumumab and Dexamethasone Vs Daratumumab Plus Bortezomib and Dexamethasone in Patients with t(11;14) Relapsed/Refractory Multiple Myeloma

https://doi.org/10.1182/blood-2021-146043

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Locations

United States, Colorado

United States, Florida

United States, Georgia

United States, Illinois

United States, Massachusetts

United States, New Jersey

United States, New York

United States, North Carolina

United States, Oregon

United States, Washington

Australia, New South Wales

Australia, South Australia

Australia, Victoria

Australia, Western Australia

Canada, Alberta

Canada, Quebec

Europe

Denmark

France

Germany

Japan