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Bcl-2 Inhibitor
Venetoclax + Tocilizumab for Multiple Myeloma
Phase 1
Recruiting
Led By Jonathan L. Kaufman, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of =< 2
Diagnosis of multiple myeloma that requires treatment and has been previously treated with: >= 3 prior line of therapy, treatment with a proteasome inhibitor, an immunomodulatory (IMiD) agent, and a CD38 monoclonal antibody, MM positive for t(11;14) translocation as determined by an analytically validated fluorescence in-situ hybridization (FISH) assay per the central laboratory testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the effect of two drugs, venetoclax and tocilizumab, on relapsed or refractory multiple myeloma. Venetoclax works by blocking a protein needed for cancer cell survival, while tocilizumab interferes with the ability of tumor cells to grow and spread. The trial will help determine the best dose of the two drugs to use and what side effects may occur.
Who is the study for?
Adults with relapsed or refractory multiple myeloma characterized by t(11;14) translocation, who have tried at least three prior therapies including a proteasome inhibitor, an IMiD agent, and a CD38 monoclonal antibody. Participants must not be pregnant or breastfeeding, should have adequate organ function and no recent significant medical conditions or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing the combination of Venetoclax and Tocilizumab to determine the optimal doses and potential side effects in patients whose multiple myeloma has returned after treatment or hasn't responded to previous therapy. Venetoclax targets proteins essential for cancer cell survival while Tocilizumab may prevent tumor growth.See study design
What are the potential side effects?
Potential side effects include but are not limited to: immune system reactions, infections due to lowered immunity, liver issues reflected in blood tests, digestive disturbances like nausea or diarrhea, fatigue, possible impact on blood counts leading to increased bleeding risk or anemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can perform daily activities with minimal assistance.
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I have multiple myeloma, treated with 3+ therapies including a proteasome inhibitor, an IMiD agent, and a CD38 antibody, and positive for t(11;14).
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I am able to have children and have a negative pregnancy test.
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My tests show I have measurable levels of a specific protein linked to my disease.
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I am over 100 days post-transplant with good blood counts and no major organ issues.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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)
Secondary outcome measures
Complete response rate
Duration of response (DOR)
Incidence of adverse events (AEs)
+5 moreSide 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, tocilizumab)Experimental Treatment2 Interventions
Patients receive tocilizumab IV on day -7 of cycle 1, and on day 1 of subsequent cycles. Patients also receive venetoclax PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,350 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,059 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,460 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,907 Patients Enrolled for Multiple Myeloma
Jonathan L. Kaufman, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any active cancers in the last 3 years, except for certain skin cancers, low-grade prostate cancer, or cancers that were completely removed or treated.I can perform daily activities with minimal assistance.I am a woman who is either postmenopausal, cannot have children, or I am using birth control as specified.I do not have any major health issues like heart problems or infections that are not under control.I have multiple myeloma, treated with 3+ therapies including a proteasome inhibitor, an IMiD agent, and a CD38 antibody, and positive for t(11;14).You have eaten grapefruit, Seville oranges, or star fruit within 3 days before taking the study drug.I am able to have children and have a negative pregnancy test.I have not had a live vaccine in the last 60 days.My tests show I have measurable levels of a specific protein linked to my disease.I am over 100 days post-transplant with good blood counts and no major organ issues.I haven't had cancer treatment or still have side effects from the last one within the last 2 weeks.I am 18 years old or older.I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.I have not taken high doses of steroids like prednisone or dexamethasone in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, tocilizumab)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
To what extent could Venetoclax be detrimental to human health?
"Since this is a Phase 1 clinical trial, with limited evidence to support safety and efficacy, we assigned Venetoclax a score of 1."
Answered by AI
Is there still an opportunity for people to participate in this research endeavor?
"At this time, clinicaltrials.gov does not list any active recruitment for the trial posted on December 2nd 2022 and last edited October 24th 2022. Nevertheless, 807 other experiments are actively recruiting patients presently."
Answered by AI
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