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.

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AbbVie
Study ID
NCT03539744
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pomalidomide — DRUG
    capsule, oral
  • Dexamethasone — DRUG
    oral, locally available form
  • Venetoclax — DRUG
    tablet; oral

Study Details

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.

Key Dates

Start date
Oct 22, 2018
Status verified
Jun 2025
Primary completion
Aug 31, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
265 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 VenDex
    Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
  • Active Comparator: Arm 2 PomDex
    Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 43 months from first randomization ]

Locations (19)

FacilityCityStateZIPSite coordinators
Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407TucsonArizona85719-1478-
VA Central California Health Care System /ID# 200047FresnoCalifornia93703-2223-
University of California, Los Angeles /ID# 171524Los AngelesCalifornia90095-
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904AuroraColorado80045-
Mayo Clinic /ID# 200075JacksonvilleFlorida32224-
Cleveland Clinic Florida /ID# 208884WestonFlorida33331-3609-
Duplicate_Norton Cancer Institute /ID# 200834LouisvilleKentucky40202-3700-
University of Maryland, Baltimore /ID# 217422BaltimoreMaryland21201-
Boston Medical Center /ID# 223606BostonMassachusetts02118-
Barbara Ann Karmanos Cancer In /ID# 201377DetroitMichigan48201-
Duplicate_Henry Ford Hospital /ID# 171531DetroitMichigan48202-
Mayo Clinic - Rochester /ID# 201091RochesterMinnesota55905-0001-
Columbia University Medical Center /ID# 200715New YorkNew York10032-3729-
Cleveland Clinic Main Campus /ID# 202247ClevelandOhio44195-
Fairview Hospital - Moll Pavilion /ID# 208919ClevelandOhio44111-5605-
UPMC Hillman Cancer Ctr /ID# 200063PittsburghPennsylvania15232-
MD Anderson Cancer Center at Texas Medical Center /ID# 200060HoustonTexas77030-4000-
Huntsman Cancer Institute /ID# 218406Salt Lake CityUtah84112-5500-
VA Puget Sound Health Care System /ID# 222708SeattleWashington98108-1597-

Find similar trials in Tucson, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Duplicate_University of Arizona Cancer Center - North Campus· Tucson, AZVA Central California Health Care System· Fresno, CAUniversity of California, Los Angeles· Los Angeles, CARocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System· Aurora, COMayo Clinic· Jacksonville, FLCleveland Clinic Florida· Weston, FL

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