A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Mar 24, 2024
  • participants needed
    244
  • sponsor
    AbbVie
Updated on 14 May 2021
measurable disease
dexamethasone
lenalidomide
proteasome inhibitor
refractory multiple myeloma
pomalidomide

Summary

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Pomalidomide, Dexamethasone, venetoclax
Clinical Study IdentifierNCT03539744
SponsorAbbVie
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented diagnosis of multiple myeloma (MM) based on standard 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 MM positive for t(11;14)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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