Clinical Trial: Daratumumab for Newly Diagnosed Older Myeloma Patients

For older, more frail patients, what is the best first line of therapy in the newly diagnosed setting? We know that adding daratumumab, the first monoclonal antibody approved for treating multiple myeloma, improves outcomes when combined with other standard of care myeloma drugs. A study open at the H. Lee Moffitt Cancer Center and Research Institute will help determine how daratumumab is best used for newly diagnosed patients and which combination therapies may be most effective.  

The first line of therapy is key, and for older patients who may not be able to receive intense therapy, various strategies are being explored. Daratumumab can be added to many treatment combinations without significant addition of side effects. The addition of daratumumab produces a profound enhancement in myeloma therapy that even improves over time according to an update of an important study presented at last year’s American Society of Hematology (ASH) 2022 meeting.

About the Study

Newly diagnosed myeloma patients over the age of 65 can join the study at the H. Lee Moffitt Cancer Center and Research Institute. The three study arms will include:

• Arm A: Patients will receive daratumumab by subcutaneous injection weekly with 20 mg of dexamethasone once a week for two months. Patients who receive a partial response or better will continue on this arm.
• Arm B: Patients with less than a partial response to Arm A may have lenalidomide added to their treatment, given on days 1-21 of each 28-day cycle.
• Arm C: Patients with less than a partial response to Arm A may have bortezomib added to their treatment, given weekly by subcutaneous injection at a starting dose of 1/3 mg/m^2 Days 1,8 and 15 of each 28 day treatment cycle.

The study is first seeking to measure the overall response rate of up to 8 months and is secondly seeking to measure the progression free survival and overall survival up to two years.

For more information about the inclusion/exclusion criteria, click here.

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