The aim of this study is to assess whether the study drug elranatamab (also known as PF-06863135) can provide better clinical benefit compared to lenalidomide as maintenance therapy in people with newly diagnosed multiple myeloma and undergoing ASZT.
Aim of the study
The aim of this study is to assess whether the study drug elranatamab (also known as PF-06863135) can provide better clinical benefit compared to lenalidomide as maintenance treatment in people with newly diagnosed multiple myeloma and undergoing ASZT
Who can take part?
Patients with newly diagnosed multiple myeloma after autologous stem cell transplantation
Procedure
If you are eligible for this study, you will be asked to participate in this study for about 7 years. You will continue to receive the study drug until either radiological examinations show that your cancer is worsening, the investigator believes that you are no longer benefiting from the study drug, you experience side effects that are too severe, or you decide to stop participating.
Your treatment is divided into "cycles", with each cycle lasting 28 days by definition.
You will be asked to provide biological samples (e.g. saliva, blood, urine and bone marrow samples) and undergo procedures that are mainly part of routine medical practice. The investigator will decide whether or not you are eligible for the study.
They are randomized (randomly assigned) to arm B (lenalidomide) or arm C (elranatamab).
If you are assigned to the elranatamab group (Arm C), you will need to see the investigator every 2 weeks from Cycle 1 Day 15 to undergo study procedures, including study drug administration, and to provide information about your health. In the first cycles, you can make additional weekly appointments with your investigator to undergo blood tests and examinations. The first two times you receive the study drug elranatamab for arm C, overnight hospital stays are also required.
If you are assigned to the group receiving lenalidomide (Arm B), you will need to see the investigator every week or every 2 weeks for the first 6 months and every 4 weeks thereafter to undergo study procedures and provide information about your health.
Compensation
Original study name
A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION
BASEC number
2023-00172
Sponsors