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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

Marizomib

Clifton Mo, MD

Andrew Branagan, MD

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.

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.

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

MTD is defined as the highest dose level where no patients (of the 6 treated) develop a dose limiting toxicity (DLT)

Toxicity summaries will be stratified by dose level, grade, and treatment attribution

Assessed using the updated International Myeloma Working Group Response Criteria (IMWG) (Rajkumar 2011).

Assessed using the updated International Myeloma Working Group Response Criteria

Bristol-Myers Squibb

Dana-Farber Cancer Institute

Principal Investigator

Spots Global Cancer Trial Database for cns myeloma

Every month we try and update this database with for cns myeloma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cns myeloma

Every month we try and update this database with for cns myeloma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cns myeloma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.