Study on Daratumumab and Lenalidomide vs. Lenalidomide Alone for Maintenance Treatment in Newly Diagnosed Multiple Myeloma Patients

Inclusion Criteria

• Have newly diagnosed multiple myeloma and have completed at least 4 cycles of initial therapy.
• Have received high-dose therapy and a stem cell transplant within 12 months of starting initial therapy.
• Be within 6 months of the stem cell transplant at the time of joining the study.
• Show a very good partial response or better to treatment based on specific criteria.
• Have bone marrow samples collected before starting initial treatment or before the transplant, or have existing test results showing minimal residual disease.
• Have detectable minimal residual disease as determined by specific tests.
• Have a performance status score of 0, 1, or 2, indicating good overall health.

Exclusion Criteria

• Have a history of another cancer unless treatment was completed at least 2 years ago and there is no evidence of disease.
• Have not progressed on multiple myeloma therapy before joining the study.
• Have previously received treatment with daratumumab or similar therapies.
• Have received certain types of radiation therapy or plasmapheresis shortly before joining the study.
• Show signs of cancer affecting the brain or spinal cord.
• Have chronic obstructive pulmonary disease (COPD) with severely reduced lung function.
• Have moderate or severe asthma that is not well-controlled.
• Have certain viral infections, including HIV, active hepatitis B, or hepatitis C, unless successfully treated.