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.

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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 facts

Study ID

NCT03539744

Run by

AbbVie

People needed

265

Starts

2018-10-22

Expected to finish

2027-11-01

Last updated by the study team

2025-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
• Measurable disease at screening as defined per protocol.
• Has received at least 2 prior lines of therapy as described in the protocol.
• Has had documented disease progression on or within 60 days after completion of the last therapy.
• Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
• Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
• Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
• An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.

You may not qualify if…

• History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
• History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
• Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
• Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
• Known central nervous system involvement of MM.
• Concurrent conditions as listed in the protocol.

Where it is running

• VA Central California Health Care System /ID# 200047 — Fresno, California, United States
• University of California, Los Angeles /ID# 171524 — Los Angeles, California, United States
• Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904 — Aurora, Colorado, United States
• Mayo Clinic /ID# 200075 — Jacksonville, Florida, United States
• Cleveland Clinic Florida /ID# 208884 — Weston, Florida, United States
• Duplicate_Norton Cancer Institute /ID# 200834 — Louisville, Kentucky, United States
• University of Maryland, Baltimore /ID# 217422 — Baltimore, Maryland, United States
• Boston Medical Center /ID# 223606 — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer In /ID# 201377 — Detroit, Michigan, United States
• Duplicate_Henry Ford Hospital /ID# 171531 — Detroit, Michigan, United States
• Mayo Clinic - Rochester /ID# 201091 — Rochester, Minnesota, United States
• Columbia University Medical Center /ID# 200715 — New York, New York, United States
• Fairview Hospital - Moll Pavilion /ID# 208919 — Cleveland, Ohio, United States
• Cleveland Clinic Main Campus /ID# 202247 — Cleveland, Ohio, United States
• UPMC Hillman Cancer Ctr /ID# 200063 — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center at Texas Medical Center /ID# 200060 — Houston, Texas, United States
• Huntsman Cancer Institute /ID# 218406 — Salt Lake City, Utah, United States
• VA Puget Sound Health Care System /ID# 222708 — Seattle, Washington, United States
• Liverpool Hospital /ID# 202431 — Liverpool, New South Wales, Australia
• Sydney Adventist Hospital /ID# 222874 — Wahroonga, New South Wales, Australia
• Wollongong Hospital /ID# 205545 — Wollongong, New South Wales, Australia
• ICON Cancer Care - Townsville /ID# 206565 — Hyde Park, Queensland, Australia
• Icon Cancer Centre /ID# 205663 — South Brisbane, Queensland, Australia
• The Queen Elizabeth Hospital /ID# 202432 — Woodville South, South Australia, Australia
• Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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