NCT05050305

Marizomib Central Nervous System (CNS)

A Phase 2 Study With Safety Run-In of Marizomib, Pomalidomide, and Dexamethasone For Relapsed and Refractory Multiple Myeloma and CNS Myeloma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
DRUG	Marizomib	Intravenous Infusion
DRUG	Pomalidomide	Taken orally
DRUG	Dexamethasone	Taken orally

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2021-09-20
• Last updated: 2024-07-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study