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Official Title
A Phase 1 Study Evaluating the Safety of Venetoclax and Tocilizumab in African American and Non-African American Subjects With Relapsed or Refractory t(11;14) Multiple Myeloma
Phase
Phase 1
Sponsor
Emory University
Enrollment
72
Timeline
Oct 2022 → Feb 2027
About This Study
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.
Eligibility Criteria
Exclusion Criteria
- 1Subject exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to:
- 2Acute infection within 14 days prior to first dose of study drug requiring antibiotic, antifungal, or antiviral therapy
- 3Diagnosis of fever and neutropenia within 1 week prior to first dose of study drug
- 4Subject has a cardiovascular disability status of New York Heart Association class \>= 3
- 5Subject 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
- 6Subject has a history of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions:
- 7Adequately treated in situ carcinoma of the cervix uteri,
- 8Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin,
- 9Localized prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen (PSA) levels off treatment
- 10Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
- 11Known human immunodeficiency viral (HIV) infection
- 12Active hepatitis B or C infection based on screening blood testing
- 13Subject is receiving other ongoing anti-myeloma therapy
- 14Subject has received any of the following within 7 days prior to the first dose of study drug:
- 15Strong or moderate CYP3A inhibitors, or
- 16Strong or moderate CYP3A inducers
- 17Subject 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
- 18Subject has received prior treatment with a BCL-2 family inhibitor
- 19Subject 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
- 20Subject 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
- 21Subject has received immunization with live vaccine within 60 days of dosing
- 22Recent 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
- 23Subject's decision to not divulge the race
Locations
1 site participating in this study
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Jonathan L. Kaufman, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →