This study aims to compare bortezomib, lenalidomide, and dexamethasone with carfilzomib, lenalidomide, and dexamethasone. The outcome to be measured is the overall survival (time from treatment until death from any cause).
The details
Multiple myeloma is a cancer of the plasma cells in the blood. Treatment for multiple myeloma includes chemotherapy. Bortezomib (Velcade) and carfilzomib (Kyprolis) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide (Revlimid) and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is suggested that giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer cells.
This trial will test different combinations of treatments in untreated myeloma patients. The main outcome will be measured as the time from treatment until disease progression or death from any cause.
Who are they looking for?
The study is recruiting 756 participants with newly diagnosed, symptomatic multiple myeloma. Participants should have less than 4 weeks of prior chemotherapy. Participants should be willing to be on acceptable birth control methods while taking lenalidomide. Participants should not be pregnant. Participants should not have any uncontrolled seizure disorder. Participants should not have any other uncontrolled illness or active infection.
How will it work
Participants will be randomly assigned to one of 4 treatment groups. Participants in the first treatment group will receive bortezomib, lenalidomide, and dexamethasone. Treatment repeats every 3 weeks for 12 courses as long as there is no disease progression or severe side effect. Participants in the second treatment group will receive carfilzomib, lenalidomide, and dexamethasone. Treatment repeats every 4 weeks for 9 courses as long as there is no disease progression or severe side effect. Participants in the third treatment group will receive lenalidomide. Treatment repeats every 4 weeks for 24 courses as long as there is no disease progression or severe side effect. Participants in the fourth treatment group will receive lenalidomide. Treatment repeats every 4 weeks as long as there is no disease progression or severe side effect. Participants will be followed-up over time for any worsening disease.
