Full TitleA Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib vs. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Relapsing on Lenalidomide as Part of First Line Therapy
Lenalidomide, bortezomib, and carfilzomib are drugs used to treat multiple myeloma. Despite treatment, however, some patients experience recurrence of their disease. Pomalidomide and dexamethasone have been used to treat patients whose myeloma has returned after at least two prior regimens of therapy, and the combination of both medications has been approved by the FDA.
In this study, researchers want to see if adding the drug ixazomib to pomalidomide and dexamethasone is safe (phase I portion of the study), and if this three-drug combination is more effective against recurrent myeloma than pomalidomide and dexamethasone alone (phase II portion). Memorial Sloan Kettering is participating in the phase I part of the study to find the optimal doses of these three drugs when given together. Ixazomib is approved for treating recurrent multiple myeloma when given with lenalidomide and dexamethasone; this is the first time it will be combined with pomalidomide and dexamethasone.
Patients in this study will include those with multiple myeloma that has returned despite at least two prior regimens of therapy that included lenalidomide and either bortezomib or carfilzomib. Ixazomib is in the same class of drugs as bortezomib and carfilzomib, but may be more powerful and is given orally (by mouth). Pomalidomide is already approved for treating multiple myeloma and is in the same class of drugs as lenalidomide. Pomalidomide and dexamethasone are also taken orally.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have multiple myeloma that continued to grow within 60 days of completing therapy that included lenalidomide and either bortezomib or carfilzomib.
- Patients must have had at least two prior regimens of therapy.
- At least 2 weeks must pass since completion of prior chemotherapy or radiation therapy and entry into the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.