Open Actively Recruiting

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

About

Brief Summary

The purpose of this study is to compare the effectiveness of venetoclax and dexamethasone versus pomalidomide and dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) multiple myeloma. This study has two arms (Arm 1 and Arm 2) and will evaluate whether the combination of venetoclax and dexamethasone works better than the combination of pomalidomide and dexamethasone to treat multiple myeloma. Patients will be randomly assigned by chance (similar to selecting one of two straws) to receive one of the following treatments: • Arm 1: Venetoclax and dexamethasone (1 in 2 chance) • Arm 2: Pomalidomide and dexamethasone (1 in 2 chance) About 5 patients at UCLA will participate. There will be approximately 244 subjects at approximately 90 research centers globally Patients will have a screening visit, weekly visits for the first two months, and then monthly visits thereafter until completion of the treatment. There will also be follow-up visits.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects diagnosed with multiple myeloma that had improved for a period of time and then worsened (relapsed) or is non responsive to standard treatment (refractory). For more information about the eligibility criteria for this trial, refer to the Health Professional version.

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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Study Stats
Protocol No.
18-000898
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03539744
For detailed technical eligibility, visit ClinicalTrials.gov.