This phase 2 clinical trial will test the effectiveness of IRD, a combination therapy of ixazomib, lenalidomide, and dexamethasone, after stem cell transplantation, followed by ixazomib or lenalidomide as a maintenance therapy in treating multiple myeloma. The primary outcome will be measured by the disease improvement.
IRD is a combination chemotherapy containing ixazomib (Ninlaro), lenalidomide (Revlimid), and dexamethasone (Ozurdex). The combination may increase survival and decrease the risk of disease progression after a stem cell transplant. The therapy has been shown to have lower risk of side effects compared to other combination therapies, and the drugs can be taken by mouth, making administration easier. Ixazomib or lenalidomide as a maintenance therapy may also help improve the response to treatment.
The study will examine the disease improvement for 112 days. Overall survival (time from treatment until death from any cause), time until disease progression, and side effects will also be considered.
Who are they looking for?
This trial is recruiting 240 patients with multiple myeloma who have received at least 2 cycles of an initial therapy. Patients should have adequate organ function. Men and women of childbearing potential must use contraceptives.
Patients should not have received organ transplants or have a digestive disease or surgery that may interfere with absorption. Ideal candidates should not have undergone surgery within 14 days prior to treatment.
How will it work
All patients will receive IRD treatment starting between 80 and 120 days after autologous stem cell transplantation (stem cells are collected from the patient and transplanted back). IRD will be given in 28-day cycles for 4 cycles. After this period, patients will be divided into two groups and receive either ixazomib or lenalidomide throughout a 28-day cycle for up to 3 years.