Marizomib + Dexamethasone + Pomalidomide for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byClifton Mo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clifton Mo, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with multiple myeloma involving the central nervous system who've had prior treatments including an IMiD and a proteasome inhibitor. They must not be pregnant, agree to follow specific safety programs, have measurable disease levels, and can't have severe heart conditions or active infections. People with recent major surgeries or those on certain drugs are excluded.

Inclusion Criteria

I can take daily aspirin, or an alternative if allergic.

My multiple myeloma shows up on tests.

I have CNS involvement and my condition worsened after treatment with an IMiD and a proteasome inhibitor.

See 8 more

Exclusion Criteria

I do not have amyloidosis or plasma cell leukemia.

Any medical or psychiatric illness that in the investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study

I have an active hepatitis B infection.

See 21 more

Treatment Details

Interventions

Dexamethasone (Corticosteroid)
Marizomib (Proteasome Inhibitor)
Pomalidomide (Immunomodulatory Agent)

Trial OverviewThe study tests marizomib's safety and effectiveness combined with standard care drugs dexamethasone and pomalidomide in treating multiple myeloma. Participants will receive these medications to see if this combination helps control their cancer better than current treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Marizomib plus pomalidomide and dexamethasoneExperimental Treatment3 Interventions

A safety run-in using a modified 3+3 dose de-escalation design with relapsed/refractory multiple myeloma (RRMM) cohort, expanded to a total of 16 participants once recommended phase 2 does (RP2D) has been identified. * Marizomib (MRZ) at a pre-determined dose on Days 1, 8, 15, 22 of a 28 day study cycle * Pomalidomide (POM) at a daily predetermined dose on Days 1-21 of a 28 day study cycle * Dexamethasone (DEX) at a daily predetermined dose on Days 1, 2, 8, 9, 15, 16, 22, 23 of a 28 day study cycle Simultaneously, relapsed/refractory multiple myeloma (RRMM) with central nervous system (CNS) involvement cohort will receive an identical modified 3+3 dose de-escalation design and expanded to an efficacy-evaluable total of 30 patients once recommended phase 2 does (RP2D has been identified

Dexamethasone is already approved in Canada, Japan for the following indications: