Marizomib Central Nervous System (CNS)

Status Not yet recruiting

Clinical Trial Summary

This research is being done to test whether the investigational drug marizomib is safe and effective when used in combination with standard of care drugs for the treatment of multiple myeloma.

Clinical Trial Description

This is a Phase 2 single-arm study, incorporating two cohorts and using the combination of marizomib plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM) patients and in RRMM patients with CNS involvement. This research study involves a three drug chemotherapy regimen which includes taking the study drug marizomib, as well as pomalidomide and dexamethasone. The U.S. Food and Drug Administration (FDA) has not approved marizomib as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved pomalidomide and dexamethasone as a treatment option for multiple myeloma. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. As the study is looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of the study drug. The dose received will depend on the number of participants who have been previously enrolled in the study and how well participants have tolerated their doses. Participants will receive study treatment for as long as participants do not have serious side effects and their disease does not get worse. It is expected that about 48 people will take part in this research study. Bristol-Myers Squibb is supporting this research study by providing funding and study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05050305
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Clifton Mo, MD
Phone	617-632-4167
Email	Clifton_Mo@DFCI.HARVARD.EDU
Status	Not yet recruiting
Phase	Phase 2
Start date	March 2024
Completion date	December 2, 2027

View Details

See also
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