Venetoclax + Dexamethasone vs Pomalidomide + Dexamethasone for Multiple Myeloma
(CANOVA Trial)

Recruiting in Palo Alto (17 mi)

+279 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults with t(11;14)-positive multiple myeloma who have tried at least two treatments, including lenalidomide and a proteasome inhibitor, but their cancer has come back or didn't respond. They should be relatively active (ECOG ≤2) and have normal organ function tests. People can't join if they've had certain other cancers recently, previous treatment with BCL-2 inhibitors like venetoclax or pomalidomide, complications from stem cell transplants, or brain involvement of MM.

Inclusion Criteria

I have completed at least 2 cycles of a proteasome inhibitor treatment.

My cancer has a specific genetic feature (t(11;14)) confirmed by a lab test.

Your liver, kidney, and blood test results need to meet certain requirements as described in the study guidelines.

+10 more

Exclusion Criteria

I haven't had a stem cell transplant in the last 3-4 months.

Concurrent conditions as listed in the protocol

I have been treated with venetoclax or similar drugs before.

+3 more

Participant Groups

The study compares the effectiveness of Venetoclax plus Dexamethasone (VenDex) against Pomalidomide plus Dexamethasone (PomDex) in controlling multiple myeloma without it getting worse. Participants will be randomly assigned to one of these treatment combinations to see which works better.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 VenDexExperimental Treatment2 Interventions

Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.

Group II: Arm 2 PomDexActive Control2 Interventions

Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dexamethasone for: