Pomalidomide + Dexamethasone +/- Ixazomib for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a combination of pomalidomide and dexamethasone (a corticosteroid), with or without ixazomib, can treat multiple myeloma, a cancer affecting the bone marrow that has returned after treatment. The researchers aim to determine which drug combination is most effective and identify the safest doses. Individuals with multiple myeloma that has recurred after lenalidomide treatment and who have not yet tried pomalidomide may be suitable for this study. As a Phase 1, Phase 2 trial, the study focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take strong inducers or inhibitors of certain liver enzymes (CYP3A4 or CYP1A2) within 14 days before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using pomalidomide with low-dose dexamethasone is generally safe for patients whose multiple myeloma has returned or hasn't responded to treatment. This combination has proven effective, though it can cause serious side effects, such as a low white blood cell count (neutropenia). However, most side effects can be predicted and managed with proper care.
Adding ixazomib to this treatment has also been studied. Research indicates it may benefit patients whose multiple myeloma has returned. The safety of adding ixazomib is considered acceptable. Some side effects may occur, but patients have generally tolerated the treatment well in clinical settings. While there are risks, studies show that these treatments can be safely managed.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they introduce a novel combination approach. Unlike standard treatments like bortezomib, lenalidomide, and carfilzomib, this trial examines the addition of ixazomib, an oral proteasome inhibitor, to the existing regimen of pomalidomide and dexamethasone. Ixazomib offers the convenience of oral administration and potentially enhances the effectiveness of the treatment by targeting cancer cells in a new way. This combination could offer improved outcomes for patients, especially those who have not responded to current therapies.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that using pomalidomide and dexamethasone together is a well-established treatment for multiple myeloma that has returned or not responded to other treatments. Studies indicate that many patients respond well to this treatment, often experiencing longer periods without disease progression. In this trial, one group of participants will receive pomalidomide and dexamethasone alone, while another group will receive pomalidomide, dexamethasone, and ixazomib. Adding ixazomib to this combination might enhance its effectiveness. Specifically, one study found that the response rate increased to 63.2% with ixazomib, compared to 43.6% without it. This suggests that including ixazomib could improve treatment outcomes for those whose myeloma has returned or resisted other treatments.678910
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:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
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