drugset / Trial / NCT03701321

Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT03701321

Phase 1/2 Withdrawn National Cancer Institute (NCI)
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of venetoclax when given together with daratumumab, bortezomib, and dexamethasone, and how well they work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as venetoclax and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving venetoclax with daratumumab, bortezomib, and dexamethasone may work better in treating patients with relapsed or refractory multiple myeloma compared to standard of care treatment, including chemotherapy.

Timeline

Start
2019-01-25
Primary completion
2020-05-28
Completion
2020-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule Oral
Background Bortezomib Small molecule Subcutaneous
Background Daratumumab Monoclonal antibody Intravenous
Background Dexamethasone Small molecule Oral

Indications