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Corticosteroid

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

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 51 months from first randomization

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is studying whether a combination of venetoclax and dexamethasone is better than pomalidomide and dexamethasone at treating patients with relapsed or refractory multiple myeloma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, and potential liver issues. Both Venetoclax and Pomalidomide can also cause immune system changes that might lead to secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have been diagnosed with multiple myeloma according to IMWG standards.

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I have undergone at least 2 previous treatments as outlined.

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I have taken lenalidomide for at least 2 cycles and my condition did not improve.

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I have taken lenalidomide for at least 2 cycles and my condition did not improve.

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I can take care of myself but might not be able to do heavy physical work.

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I can take care of myself but might not be able to do heavy physical work.

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I have undergone at least 2 previous treatments as outlined in my treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with venetoclax or similar drugs before.

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

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I am experiencing complications from a previous stem cell transplant.

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My multiple myeloma has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 51 months from first randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 51 months from first randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 51 months from first randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

Change from Baseline in BPI-SF Worst Pain Score

Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)

+14 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2200

Dexamethasone

2007

Completed Phase 4

~2650