Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Sarah Larson

Description

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.

Official Title

A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Keywords

Multiple Myeloma, Cancer, Multiple Myeloma (MM), Relapsed or Refractory Multiple Myeloma (R/R MM), pharmacokinetics, CANOVA, Plasma Cell Neoplasms, Dexamethasone, Venetoclax, Pomalidomide

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California, Los Angeles /ID# 171524
    Los Angeles California 90095 United States
  • VA Central California Health Care System /ID# 200047
    Fresno California 93703-2223 United States

Lead Scientist at UCLA

  • Sarah Larson
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 19 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related info
ID
NCT03539744
Phase
Phase 3 Multiple Myeloma Research Study
Study Type
Interventional
Participants
About 265 people participating
Last Updated