NCT03399539

Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients with Relapsed Multiple Myeloma

Phase I Clinical Trial of Venetoclax (ABT-199) in Combination with Ixazomib and Dexamethasone for Patients with Relapsed Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Plasma Cell Myeloma
• T(11;14)

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given PO
DRUG	Ixazomib Citrate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2018-05-02
• Primary completion: 2021-12-20
• Completion: 2024-02-23
• First posted: 2018-01-16
• Last updated: 2024-11-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study