Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma

Running, not enrolling · Phase 1

Conditions studied: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma

In brief

This phase I trial finds out the best dose and side effects of venetoclax and tocilizumab in treating patients with t(11;14) multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Tocilizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Tocilizumab is used to treat side effects from immune therapy in patients with myeloma. Giving venetoclax and tocilizumab may kill more cancer cells.

Key facts

Study ID: NCT05391750
Run by: Emory University
People needed: 7
Starts: 2022-10-19
Expected to finish: 2028-02-12
Last updated by the study team: 2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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
Subject has a cardiovascular disability status of New York Heart Association class >= 3
Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study
Subject has a history of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions:
Adequately treated in situ carcinoma of the cervix uteri,
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin,
Localized prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen (PSA) levels off treatment
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Known human immunodeficiency viral (HIV) infection
Active hepatitis B or C infection based on screening blood testing
Subject is receiving other ongoing anti-myeloma therapy
Subject has received any of the following within 7 days prior to the first dose of study drug:
Strong or moderate CYP3A inhibitors, or
Strong or moderate CYP3A inducers
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
Subject has received prior treatment with a BCL-2 family inhibitor
Subject is pregnant, parturient, or breastfeeding; deprived of freedom by judicial or administrative decision; hospitalized and unable to provide consent, or otherwise unable to provide consent
Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days prior to the first dose of study drug
Subject has received immunization with live vaccine within 60 days of dosing
Recent corticosteroid therapy at a cumulative dose equivalent to > 140 mg of prednisone or a single dose equivalent to >= 40 mg of dexamethasone within 2 weeks prior to the first dose of study drug
Subject's decision to not divulge the race

Where it is running

Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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