Grant: Project Grant

Multiple myeloma (MM) is a cancer of the blood. It can lead to many problems, including kidney failure, bone damage, and low blood counts. Treatment for MM has improved greatly over the past 10 years with many new drugs being approved. One specific drug combination - daratumumab-lenalidomide-dexamethasone (dara-len-dex) leads to better and longer control of MM and has been shown to extend survival. Currently, patients are treated with dara-len-dex every month until they develop unacceptable side effects or the drug stops working and their MM comes back. This is called continuous therapy. Although we know this is an effective treatment option for patients, we do not know if they need to stay on it continuously or if they can discontinue daratumumab safely and be monitored. This is important to test because continuous daratumumab can have serious side effects, including COVID-19 infections, and may lead to poor quality of life (QOL). It is also very expensive to give continuously as an infusion at the cancer centre is ~$8,000/month. To test if we need continuous daratumumab, we propose conducting a clinical trial where patients who have MM are divided into two groups. One group of patients will receive daralen-dex continuously (continuous dara group) until their MM comes back or unacceptable side effects occur. The other group (fixed-duration dara) will receive dara-len-dex for 18 months. After that, if they have a good response, they will discontinue dara and remain on lenalidomide and dexamethasone tablets alone with close monitoring. We believe that fixed duration dara will be as effective, or not substantially worse, as continuous dara in keeping the MM under control. It could also decrease side effects like infections, improve patient QOL, and reduce costs. The overall goal of the trial is to have a safe and effective treatment available for older adults with newly-diagnosed MM.