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Bcl-2 Inhibitor

Venetoclax + Tocilizumab for Multiple Myeloma

Atlanta, GA
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
Must not have
Subject exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to: acute infection within 14 days prior to first dose of study drug requiring antibiotic, antifungal, or antiviral therapy, diagnosis of fever and neutropenia within 1 week prior to first dose of study drug, cardiovascular disability status of New York Heart Association class >= 3, significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease within the last 6 months
Subject has received any of the following within 14 days prior to the first dose of study drug or has not recovered to less than a grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy: any anti-myeloma therapy including chemotherapy, radiotherapy, or investigational therapy, including targeted small molecule agents, prior treatment with a BCL-2 family inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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.

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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 below
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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.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major health issues like heart problems or infections that are not under control.
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I haven't had cancer treatment or still have side effects from the last one within the last 2 weeks.
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I have not taken high doses of steroids like prednisone or dexamethasone in the last 2 weeks.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD)
Secondary study objectives
Complete response rate
Duration of response (DOR)
Incidence of adverse events (AEs)
+5 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%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Awards & Highlights

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.

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

Closest Location:Emory University Hospital/Winship Cancer Institute· Atlanta, GA

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
14,038 Previous Clinical Trials
41,156,515 Total Patients Enrolled
595 Trials studying Multiple Myeloma
191,857 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,726 Previous Clinical Trials
2,606,644 Total Patients Enrolled
27 Trials studying Multiple Myeloma
1,873 Patients Enrolled for Multiple Myeloma
Jonathan L. Kaufman, MDPrincipal InvestigatorEmory University

Media Library

Venetoclax (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05391750 — Phase 1
Multiple Myeloma Research Study Groups: Treatment (venetoclax, tocilizumab)
Multiple Myeloma Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT05391750 — Phase 1
Venetoclax (Bcl-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05391750 — Phase 1
~20 spots leftby Feb 2026