A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.
NCT03539744 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265
Last updated 2025-06-19
Summary
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
Conditions
Interventions
- DRUG
-
capsule, oral
- DRUG
-
oral, locally available form
- DRUG
-
tablet; oral
Sponsors & Collaborators
-
Roche-Genentech
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-22
- Primary Completion
- 2026-08-31
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- China
- Czechia
- Denmark
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Russia
- Singapore
- South Korea
- Spain
- Sweden
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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