A Phase III Trial of Fixed-Duration Daratumumab Versus Continuous Daratumumab Among Transplant Ineligible Older Adults with Newly-Diagnosed Multiple Myeloma Wednesday, August 02, 2023 The CCTG MY13 study receives $3,056,172 over 8 years to investigate time-limited versus continuous Daratumumab treatment for older people with multiple myeloma. Dr Hira Mian, MY13 study chair. Multiple myeloma is a cancer of the blood. Currently, patients are treated with continuous therapy daratumumab, lenalidomide and dexamethasone (dara-len-dex) every month until they develop unacceptable side effects or the drug stops working. This is an effective treatment option for patients. However researchers would like to know if they need to stay on it continuously or if they can discontinue daratumumab safely and be monitored. “This trial has the potential to change the standard of care treatment in older adults with multiple myeloma not only in Canada but around the world. If fixed duration treatment is found to be as effective as continuous treatment, this can lead to less side effects and better quality of life for patients and huge cost-saving measures for Canada’s health-care system,” says Dr Hira Mian, Juravinski Hospital hematology oncologist and MY13 study chair. It is important to test this proposed approach because daratumumab can have side effects and is also very expensive to give continuously every month at the cancer centre. To test if continuous daratumumab is needed, this clinical trial will divide patients into two groups. One group of patients will receive dara-len-dex continuously until their myeloma comes back or unacceptable side effects occur. The other group will receive dara-len-dex for a fixed duration. If they have a good response, they will discontinue daratumuab injections and remain on lenalidomide and dexamethasone tablets alone with close monitoring. It is hypothesized that fixed duration daratumumab will be as effective as continuous daratumuamb in keeping the cancer under control, with improved quality of life, decreased side effects like infections, and reduced costs. The overall goal of the trial is to have a safe and effective treatment available for older adults with newly-diagnosed multiple myeloma.
