Comparing Daratumumab-Lenalidomide-Dexamethasone to Modified Bortezomib-Lenalidomide-Dexamethasone Treatments in Older Adults Newly Diagnosed with Multiple Myeloma

What this Trial Is About

Researchers are comparing two treatment combinations for elderly patients with newly diagnosed multiple myeloma who are not planning to have a stem cell transplant initially. The study evaluates the safety and effectiveness of daratumumab, lenalidomide, and dexamethasone DRd versus a modified combination of bortezomib, lenalidomide, and dexamethasone VRd-lite. The main goals are to see which treatment better delays disease progression and achieves a negative minimal residual disease status. Participants can choose between the two treatments. Daratumumab is given through weekly intravenous infusions initially, then less frequently over several months, combined with oral lenalidomide and dexamethasone taken on specific days in 28-day cycles. The alternative group receives bortezomib injections weekly with the same oral medications on a similar schedule. After the initial treatment cycles, maintenance therapy continues with lenalidomide alone or combined with daratumumab or bortezomib based on risk assessment until disease progression or unacceptable side effects occur. During the study, participants will be regularly monitored for disease progression and safety, with evaluations including progression-free survival and minimal residual disease negativity measured at multiple timepoints over approximately five years. Additional response rates and overall survival will also be tracked. Safety assessments continue throughout the study to ensure participant well-being during treatment and follow-up.

A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma