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Clinical Trials in China / NCT03539744
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 China tracker
Sponsor
AbbVie
Phase
Phase 3
Started
2018-10-22
Last updated
2025-06-19

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

PomalidomideDexamethasoneVenetoclax

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)

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.

On this site

📄 Venclexta (venetoclax) drug profile →

More AbbVie trials in China

Other trials for the same condition

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 China