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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
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%
Rhinovirus infection
11%
Anaemia
11%
Febrile neutropenia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Gastroenteritis
11%
Pneumonia
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia pseudomonal
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Dermatitis
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

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
~1990
Dexamethasone
2007
Completed Phase 4
~2640

Find a Location

Who is running the clinical trial?

Roche-GenentechIndustry Sponsor
24 Previous Clinical Trials
3,413 Total Patients Enrolled
1 Trials studying Multiple Myeloma
231 Patients Enrolled for Multiple Myeloma
AbbVieLead Sponsor
983 Previous Clinical Trials
509,096 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,126 Patients Enrolled for Multiple Myeloma
ABBVIE INC.Study DirectorAbbVie
414 Previous Clinical Trials
151,627 Total Patients Enrolled
14 Trials studying Multiple Myeloma
2,222 Patients Enrolled for Multiple Myeloma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03539744 — Phase 3
Multiple Myeloma Research Study Groups: Arm 1 VenDex, Arm 2 PomDex
Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT03539744 — Phase 3
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03539744 — Phase 3
~68 spots leftby Aug 2026
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