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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 51 months from first randomization
Awards & highlights
CANOVA Trial 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.
CANOVA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed at least 2 cycles of a proteasome inhibitor treatment.
Select...
My cancer has a specific genetic feature (t(11;14)) confirmed by a lab test.
Select...
I have been diagnosed with multiple myeloma according to IMWG standards.
Select...
I have undergone at least 2 previous treatments as outlined.
Select...
I have taken lenalidomide for at least 2 cycles and my condition did not improve.
Select...
I have taken lenalidomide for at least 2 cycles and my condition did not improve.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have undergone at least 2 previous treatments as outlined in my treatment plan.
CANOVA Trial 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
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 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Rhinovirus infection
11%
Pneumonia pseudomonal
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
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
CANOVA 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
~2590
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
500,840 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,126 Patients Enrolled for Multiple Myeloma
Roche-GenentechIndustry Sponsor
24 Previous Clinical Trials
3,420 Total Patients Enrolled
1 Trials studying Multiple Myeloma
231 Patients Enrolled for Multiple Myeloma
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,674 Total Patients Enrolled
14 Trials studying Multiple Myeloma
2,222 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My condition worsened within 2 months after my last treatment.I have taken lenalidomide for at least 2 cycles and my condition did not improve.I haven't had a stem cell transplant in the last 3-4 months.You have a disease that can be measured according to the study guidelines.I have been treated with venetoclax or similar drugs before.I have been diagnosed with multiple myeloma according to IMWG standards.I have undergone at least 2 previous treatments as outlined.My condition worsened within 2 months after my last treatment.I have taken lenalidomide for at least 2 cycles and my condition did not improve.I can take care of myself but might not be able to do heavy physical work.I am experiencing complications from a previous stem cell transplant.I can take care of myself but might not be able to do heavy physical work.I have undergone at least 2 previous treatments as outlined in my treatment plan.My multiple myeloma has spread to my brain or spinal cord.I have not had any other cancers, including MDS, in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 VenDex
- Group 2: Arm 2 PomDex
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there dangers associated with Venetoclax treatments?
"There is some evidence of efficacy and numerous studies supporting Venetoclax's safety, so it was given a score of 3."
Answered by AI
What does the existing research say about Venetoclax?
"Venetoclax was first studied in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. 1182 completed trials later, there are 807 studies presently recruiting patients with a high concentration of them being based out of Scottsdale, Arizona."
Answered by AI
Are there any vacancies in this clinical trial for new participants?
"This is accurate. The trial in question, which was posted on October 22nd 2018 and last updated November 8th 2022, is looking for 244 individuals to participate at 11 different sites."
Answered by AI
How many test subjects are part of this clinical research?
"That is correct. The clinicaltrials.gov website has the most recent information on this study, which began recruiting on 10/22/2018. As of 11/8/2022, the study was still looking for 244 participants from 11 different locations."
Answered by AI
What are the main reasons why Venetoclax is given to patients?
"Ophthalmia, sympathetic is commonly treated with the drug Venetoclax. However, this medication can also be used to treat other conditions like communicable diseases, branch retinal vein occlusion, and macular edema."
Answered by AI
Are there clinical trial sites for this medication in the United States?
"11 clinical trial sites are recruiting patients, some of which include Cancer Treatment Centers of America (CTCA) - Scottsdale /ID# 234097 in Scottsdale, Mayo Clinic - /ID# 201091 in Rochester, and Cleveland Clinic Foundation-Florida /ID# 208884 in Weston."
Answered by AI
Who else is applying?
What state do they live in?
British Columbia
Michigan
How old are they?
18 - 65
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
BC Cancer - Vancouver /ID# 222804
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