Pomalidomide + Dexamethasone +/- Ixazomib for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with multiple myeloma that has come back. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pomalidomide and dexamethasone are more effective with or without ixazomib in treating multiple myeloma.
Who Is on the Research Team?
Peter Voorhees, MD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for patients with relapsed multiple myeloma who have previously been treated and are lenalidomide-refractory. They should not have had major surgery, chemotherapy, or radiation within specific time frames before joining the trial. Participants must practice safe contraception if applicable, have no active hepatitis B/C or hypersensitivity to study drugs, meet certain blood count criteria, and cannot be HIV positive with certain conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose-escalation study of pomalidomide and ixazomib to establish the maximum tolerated dose
Phase II Treatment
Randomized study to assess progression-free survival with pomalidomide/dexamethasone/ixazomib versus pomalidomide/dexamethasone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Ixazomib
- Pomalidomide
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Celgene Corporation
Industry Sponsor
Mark Alles
Celgene Corporation
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
Sol J. Barer
Celgene Corporation
Chief Medical Officer since 2006
PhD in Organic and Physical Chemistry from Rutgers University
Millennium Pharmaceuticals, Inc.
Industry Sponsor
Dr. Christophe Bianchi
Millennium Pharmaceuticals, Inc.
Chief Medical Officer since 2006
MD from University of Geneva
Dr. Deborah Dunsire
Millennium Pharmaceuticals, Inc.
Chief Executive Officer since 2005
MD from University of Witwatersrand