Spots Global Cancer Trial Database for Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
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Trial Identification
Brief Title: Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Official Title: Phase I Clinical Trial of Venetoclax (ABT-199) in Combination With Ixazomib and Dexamethasone for Patients With Relapsed Multiple Myeloma
Study ID: NCT03399539
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of venetoclax when given together with ixazomib citrate and dexamethasone and to see how well they work in treating patients with multiple myeloma that has come back. Venetoclax and ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with ixazomib citrate and dexamethasone may work better in treating patients with multiple myeloma.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of venetoclax in combination with ixazomib citrate (ixazomib) and dexamethasone in patients with relapsed multiple myeloma (MM). (Phase 1) SECONDARY OBJECTIVES: I. To describe toxicities associated with venetoclax, in combination with ixazomib and dexamethasone in patients with relapsed MM. (Phase 1) TERTIARY OBJECTIVES: I. To explore levels of BCL-2 family member proteins (BCL-2, BCL-x, MCL-1) on bone marrow biopsies using ribonucleic acid sequencing (RNASeq) and immunohistochemistry. OUTLINE: This is a phase I, dose-escalation study of venetoclax followed by a phase II study. Patients receive venetoclax orally (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. After completion of study treatment, patients are followed up every 3 or 6 months for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States
Contact Details
Name: Shaji Kumar, M.D.
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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