Ireland
--:--IST
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science Italy tracker
Sponsor
Phase
Phase 3
Started
2018-10-22
Last updated
2025-06-19

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Pomalidomide →Dexamethasone →Venetoclax →

Pomalidomide: capsule, oral

Dexamethasone: oral, locally available form

Venetoclax: tablet; oral

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — Up to approximately 43 months from first randomization
    PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

Trial sites (180)

FacilityCityRegionStatus
Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407 Tucson Arizona
VA Central California Health Care System /ID# 200047 Fresno California
University of California, Los Angeles /ID# 171524 Los Angeles California
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904 Aurora Colorado
Mayo Clinic /ID# 200075 Jacksonville Florida
Cleveland Clinic Florida /ID# 208884 Weston Florida
Duplicate_Norton Cancer Institute /ID# 200834 Louisville Kentucky
University of Maryland, Baltimore /ID# 217422 Baltimore Maryland
Boston Medical Center /ID# 223606 Boston Massachusetts
Barbara Ann Karmanos Cancer In /ID# 201377 Detroit Michigan
Duplicate_Henry Ford Hospital /ID# 171531 Detroit Michigan
Mayo Clinic - Rochester /ID# 201091 Rochester Minnesota
Columbia University Medical Center /ID# 200715 New York New York
Fairview Hospital - Moll Pavilion /ID# 208919 Cleveland Ohio
Cleveland Clinic Main Campus /ID# 202247 Cleveland Ohio
UPMC Hillman Cancer Ctr /ID# 200063 Pittsburgh Pennsylvania
MD Anderson Cancer Center at Texas Medical Center /ID# 200060 Houston Texas
Huntsman Cancer Institute /ID# 218406 Salt Lake City Utah
VA Puget Sound Health Care System /ID# 222708 Seattle Washington
Liverpool Hospital /ID# 202431 Liverpool New South Wales
Sydney Adventist Hospital /ID# 222874 Wahroonga New South Wales
Wollongong Hospital /ID# 205545 Wollongong New South Wales
ICON Cancer Care - Townsville /ID# 206565 Hyde Park Queensland
Icon Cancer Centre /ID# 205663 South Brisbane Queensland
The Queen Elizabeth Hospital /ID# 202432 Woodville South South Australia
Perth Blood Institute Ltd /ID# 206649 Nedlands Western Australia
Arthur J. E. Child Comprehensive Cancer Centre /ID# 218846 Calgary Alberta
BC Cancer - Vancouver /ID# 222804 Vancouver British Columbia
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 218883 Halifax Nova Scotia
CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887 Lévis Quebec
Beijing Chaoyang Hospital,Capital Medical University /ID# 216014 Beijing Beijing Municipality
Peking University Third Hospital /ID# 216371 Beijing Beijing Municipality
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 216040 Beijing Beijing Municipality
Sun Yat-Sen University Cancer Center /ID# 223828 Guangzhou Guangdong
Guangdong Provincial People's Hospital /ID# 215860 Guangzhou Guangdong
Henan Cancer Hospital /ID# 215987 Zhengzhou Henan
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850 Wuhan Hubei
Nanjing Drum Tower Hospital /ID# 223143 Nanjing Jiangsu
The First Affiliated Hospital of Soochow University /ID# 216094 Suzhou Jiangsu
The First Affiliated Hospital of Nanchang University /ID# 216954 Nanchang Jiangxi

+ 140 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03539744 on ClinicalTrials.gov ↗ ← All trials in Italy