Ixazomib Combo for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I/II trial studies the side effects and best dose of clarithromycin when given together with ixazomib citrate, pomalidomide, and dexamethasone and to see how well it works in treating patients with multiple myeloma that has not responded to previous treatment. Biological therapies, such as clarithromycin, pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clarithromycin with ixazomib citrate, pomalidomide and dexamethasone may be a better treatment for patients with multiple myeloma.
Will I have to stop taking my current medications?
The trial requires that you stop taking clarithromycin, anti-myeloma therapy, or plasmapheresis within 30 days before starting the study. Additionally, you cannot use strong inhibitors or inducers of certain liver enzymes (CYP1A2 and CYP3A) within 14 days before the first dose of study drugs.
Is the Ixazomib combination treatment generally safe for humans?
The combination of ixazomib, pomalidomide, and dexamethasone has been studied in patients with relapsed or refractory multiple myeloma and is generally well-tolerated. Common side effects include anemia (low red blood cell count), neutropenia (low white blood cell count), and thrombocytopenia (low platelet count), but these are manageable. Peripheral neuropathy (nerve damage) was infrequent, indicating the treatment is relatively safe for human use.12345
What makes the Ixazomib Combo drug unique for treating multiple myeloma?
The Ixazomib Combo drug is unique because it includes ixazomib, the first oral proteasome inhibitor, which allows for an all-oral treatment regimen. This combination is designed to be effective and convenient for patients with multiple myeloma, especially those who have relapsed or are refractory to other treatments.56789
What data supports the effectiveness of the drug combination Ixazomib, Clarithromycin, Dexamethasone, and Pomalidomide for treating multiple myeloma?
Research shows that ixazomib, when combined with other drugs like dexamethasone, is effective in treating multiple myeloma, with a significant number of patients experiencing a positive response. Additionally, clarithromycin combined with dexamethasone has shown effectiveness in similar treatments, suggesting potential benefits in this combination.13689
Who Is on the Research Team?
Joseph M. Tuscano
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
This trial is for patients with multiple myeloma that's gotten worse after treatment. They must have had a biopsy confirming the diagnosis, measurable disease, and be in fairly good health (ECOG status 0-2). Participants need to agree to use contraception and should not have other serious illnesses or recent treatments that could affect the study drugs' absorption or their own recovery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pomalidomide, ixazomib citrate, clarithromycin, and dexamethasone in 28-day cycles for 6 courses
Maintenance Therapy
Participants continue to receive pomalidomide, ixazomib citrate, and dexamethasone with clarithromycin in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clarithromycin
- Dexamethasone
- Ixazomib Citrate
- Pomalidomide
Clarithromycin is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joseph Tuscano
Lead Sponsor
Celgene
Industry Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
Takeda
Industry Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier