This trial will compare the effectiveness of two maintenance therapies in patients with multiple myeloma (MM) after a stem cell transplant (SCT). The main outcome to be measured will be the average time from treatment until death due to any cause.
Maintenance therapy is commonly given after SCT to help delay relapse (cancer recurrence). This therapy involves a low dose of one or more anti-cancer drugs over a long period. Lenalidomide (Revlimid) is often used on its own as maintenance therapy.
This study will determine whether adding daratumumab (Darzalex) to lenalidomide maintenance therapy improves outcomes for patients with MM. The main outcome to be measured will be overall survival (the average time from treatment until death due to any cause).
Who are they looking for?
This study aims to recruit 1100 patients with MM. Patients should have had at least 2 cycles of chemotherapy 1 year before study entry. Patients should be willing and able to take blood thinners, such as warfarin (Coumadin). Patients must have adequate kidney, liver, and digestive function. Patients must be good candidates for SCT or have already had it within 180 days of study entry.
Patients must not have amyloid disease (amyloid protein build-up in organs). Patients should also not have disease that is growing or spreading or stopped responding to previous treatment with either of the study drugs. Patients with COPD, asthma, uncontrolled infections, or allergies to either of the study drugs cannot participate. All patients must agree to use contraception. Female patients must also agree to not become pregnant within 3 months of the last dose of study treatment.?
How will it work
This study will have two groups of patients. After SCT, one group will receive maintenance therapy with lenalidomide while the other group will receive lenalidomide plus daratumumab. Maintenance therapy will be given for 2 years. Patients with remaining cancer will continue treatment for up to 7 years. Patients with no residual disease will either continue or stop treatment.
The main outcome to be measured will be overall survival after treatment. The number of patients alive without tumor growth or spread will also be measured. The number of patients who have tumor shrinkage or no signs of cancer after treatment will also be measured. Patients will be followed for up to 15 years.