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Corticosteroid
Venetoclax + Ixazomib + Dexamethasone for Multiple Myeloma
Phase 1
Waitlist Available
Led By Shaji Kumar, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 2: 1-3 prior lines of therapy and should have received a proteasome inhibitor and an immunomodulatory drug
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing the combination of venetoclax, ixazomib citrate, and dexamethasone to treat patients with multiple myeloma that has returned.
Who is the study for?
This trial is for adults with relapsed multiple myeloma who've had at least one prior treatment including a proteasome inhibitor and an immunomodulatory drug. They must be willing to use birth control, provide consent, have a life expectancy of at least 12 weeks, and meet specific health criteria like certain blood cell counts. Pregnant women, those with recent major surgery or other cancers within the last two years (except certain skin cancers), and individuals on strong CYP3A inhibitors are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of Venetoclax, Ixazomib Citrate, and Dexamethasone in patients whose multiple myeloma has returned. It aims to find the safest dose that works best by blocking enzymes cancer cells need to grow while also killing or stopping them from dividing.See study design
What are the potential side effects?
Potential side effects include nausea, diarrhea, fatigue, risk of infection due to low blood cell counts, possible liver issues indicated by changes in blood tests results. There may also be risks related to bone marrow suppression leading to anemia or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had 1-3 treatments before, including a proteasome inhibitor and an immunomodulatory drug.
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I can take care of myself and am up and about more than half of my waking hours.
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My white blood cell count is healthy without needing medication.
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I have had multiple myeloma treatment before, including a proteasome inhibitor and an immunomodulatory drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of venetoclax in combination with ixazomib and dexamethasone (Phase 1)
Overall survival
Progression-free survival
+3 moreSecondary outcome measures
Incidence of adverse events
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, ixazomib citrate, dexamethasone)Experimental Treatment4 Interventions
Patients receive venetoclax PO daily on days 1-28, ixazomib citrate PO once weekly on days 1, 8, and 15, and dexamethasone PO on days 1, 8, 15, and 22 for courses 1-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Ixazomib Citrate
2012
Completed Phase 2
~200
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,570 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,570 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,076 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,704 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,660 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,123 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with ixazomib or was in a study for it.I've had 1-3 treatments before, including a proteasome inhibitor and an immunomodulatory drug.You are currently receiving any experimental treatments or other types of chemotherapy.I am currently breastfeeding.My multiple myeloma can be measured by medical tests.Your liver function test results must be within a certain range within 14 days before you join the study.Your alkaline phosphatase level must be no higher than 750 U/L within 14 days before you join the study.My heart condition does not severely limit my daily activities.You are expected to live for at least 12 more weeks.I can take care of myself and am up and about more than half of my waking hours.You have more than 200 milligrams of a specific type of protein in your urine, as measured over 24 hours.You have a high level of a specific protein in your blood.My white blood cell count is healthy without needing medication.Your total bilirubin levels should be within a certain range in the blood test taken within the last 14 days before enrolling in the study.I have mostly recovered from side effects of my last chemotherapy.I experience significant numbness, tingling, or pain in my hands or feet.I have a stomach or intestine condition that affects my ability to take pills.I haven't had any cancer besides non-melanoma skin cancer or carcinoma in situ, or if I have, it was more than 2 years ago and fully treated.My kidney function test from the last two weeks shows my kidneys are working well.Your hemoglobin level must be at least 8.0 grams per deciliter within 14 days before joining the study.Your blood test shows high levels of immunoglobulin free light chain and an abnormal ratio of kappa to lambda free light chain.I haven't taken strong or moderate CYP3A affecting drugs in the last 2 weeks.I have had multiple myeloma treatment before, including a proteasome inhibitor and an immunomodulatory drug.I have not received any live-virus vaccines in the last 28 days.I am of childbearing age and do not plan to use birth control.Women who can have children must have a recent negative pregnancy test.I have not had major surgery in the last 14 days.I do not have any major health issues that would prevent me from joining the trial.Your platelet count is at least 75,000/uL and if your marrow plasma cells are over 50%, it should be at least 50,000/uL.I had radiotherapy less than 14 days ago, or less than 7 days if the treated area was small.I have a known history of HIV or active hepatitis.My test shows I have the t(11;14) genetic feature in my cancer cells.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, ixazomib citrate, dexamethasone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many participants have registered for this research endeavor?
"Unfortunately, this clinical trial has ended its recruitment process. Initially posted on May 2nd 2018 and last updated on April 8th 2022, the study is no longer in need of patients. However, should you seek out other medical trials there are currently 807 studies actively recruiting participants with t(11;14) diagnoses and 779 research projects looking for individuals taking Venetoclax treatments."
Answered by AI
What is the usual purpose of Venetoclax?
"Venetoclax is typically used to manage ophthalmia, sympathetic. Additionally, it has demonstrated efficacy in treating eye diseases such as branch retinal vein occlusion and macular edema."
Answered by AI
Are there any vacancies for enrolment in this clinical trial?
"This clinical trial is now closed for participant recruitment and was last updated on April 8th, 2022. However, if you are in search of other studies there are currently 807 trials with t(11;14) actively enrolling subjects and 779 clinical trials utilizing Venetoclax searching for candidates."
Answered by AI
Are there precedents of examination involving Venetoclax?
"Currently, 779 clinical trials on the efficacy of Venetoclax are ongoing, with 173 in Phase 3. Edmonton Alberta is one such site conducting research into this drug; however, it's being studied at over 25 thousand medical centres around the world."
Answered by AI
Has the FDA given its authorization for the utilization of Venetoclax?
"This drug's safety is only supported by limited clinical evidence, so it was given a score of 1."
Answered by AI
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