Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma in Relapse; Refractory Multiple Myeloma; Multiple Myeloma
• Interventions: Drug: pomalidomide; Drug: marizomib; Drug: low-dose dexamethasone

• Registration Number: NCT02103335
• Lead Sponsor: Celgene

Brief Summary

This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are:

* Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory drug) that has been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of multiple myeloma.

* Marizomib is an investigational drug being developed by Triphase that is being studied for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet been approved by health authorities, such as the FDA, for general use but have been approved for use in specific clinical studies. Marizomib inhibits a cellular machine called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome inhibitors have been shown to be effective in the treatment of multiple myeloma.

* Dexamethasone is a corticosteroid drug that affects the immune system (an immunomodulatory drug) that has been approved by the FDA for the treatment of multiple myeloma.

This is the first study to evaluate the three-drug combination of pomalidomide (POM), marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory multiple myeloma.

The primary objective of this study is to determine the best drug dosing levels for this three-drug combination, including the highest safe doses and/or the recommended doses for future clinical studies of this drug combination. The secondary purposes of this study are to determine the safety of this drug combination and its effectiveness in treating relapsed or refractory multiple myeloma. The study will include examination of levels of all three drugs in the blood during various time points during treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Study Start: 2014-06-05
• Primary Completion: 2016-10-03
• Study Completion: 2016-11-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group Assignment	pomalidomide	Combination Pomalidomide, low-dose Dexamethasone, and Marizomib:
Single Group Assignment	low-dose dexamethasone	Combination Pomalidomide, low-dose Dexamethasone, and Marizomib:
Single Group Assignment	marizomib	Combination Pomalidomide, low-dose Dexamethasone, and Marizomib:

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose and/or recommended Phase 2 dose	Continuous up to one year

Secondary Outcome Measures

Name	Time	Method
Adverse events	Up to 5 years
Response rate	Up to 5 years

Trial Locations

Locations (6)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia

Alfred Hospital; 🇦🇺 Prahran, Victoria, Australia