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

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/6/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Prashant Kapoor, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Prashant Kapoor, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20447066

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