Ixazomib + Pomalidomide + Dexamethasone for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have certain treatments like strong CYP3A inducers or inhibitors 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.
What data supports the effectiveness of the drug combination Ixazomib, Pomalidomide, and Dexamethasone for treating multiple myeloma?
Research shows that the combination of Pomalidomide and low-dose Dexamethasone is effective in prolonging survival and improving response rates in patients with relapsed and refractory multiple myeloma. Additionally, a study on the combination of Ixazomib, Pomalidomide, and Dexamethasone found it to be well-tolerated and effective, with nearly half of the patients achieving a partial response or better.12345
Is the combination of Ixazomib, Pomalidomide, and Dexamethasone safe for humans?
The combination of Ixazomib, Pomalidomide, and Dexamethasone has been studied in patients with multiple myeloma and is generally well-tolerated, though some patients experienced serious side effects like fatigue, infections, and low blood cell counts. Pomalidomide and Dexamethasone together have a manageable safety profile, with common side effects including low blood cell counts and infections.12567
What makes the drug combination of Ixazomib, Pomalidomide, and Dexamethasone unique for treating multiple myeloma?
This drug combination is unique because it is an all-oral regimen that combines the first oral proteasome inhibitor, ixazomib, with pomalidomide, an immunomodulatory agent, and dexamethasone, a steroid, offering a convenient and effective treatment option for patients with relapsed or refractory multiple myeloma who have limited treatment choices.12357
Research Team
Omar Nadeem, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults with Multiple Myeloma that has come back or didn't respond to treatment. They must have tried at least two therapies, be in decent physical shape (able to perform daily activities), and not have had certain other treatments recently. Women who can get pregnant must follow specific pregnancy testing rules.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Phase I will follow a standard '3 +3' dose escalation design to test the safety of ixazomib with pomalidomide and dexamethasone
Phase II Treatment
Single-arm open-label enrollment with dosing based on the MTD determination in Phase I
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
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?
Paul Richardson, MD
Lead Sponsor
Paul G. Richardson, MD
Lead Sponsor
Omar Nadeem, MD
Lead Sponsor
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