This study will investigate the effectiveness of daratumumab (Darzalex) added to VR-d regime [bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (Decadron)] versus VR-d alone in untreated multiple myeloma (MM). The development of minimal residual disease (MRD; a very small number of cancer cells remaining after treatment) will be the main outcome measured.
The details
Stem cell transplant is a commonly considered therapy for untreated MM. This involves the transfer of stem cells. However, anti-cancer medicines may often be the first choice for treatment. The VR-d regime is commonly used in patients with MM. Daratumumab is a targeted therapy for MM. It targets a protein present on cancer cells and it helps to slow down or stop the disease. It is important to investigate the effects of different combinations of these therapies.
This study is investigating the impact of adding daratumumab to VR-d treatmentversus VR-d alone in untreated multiple myeloma (MM). The main result that will be measured will be the percentage of patients who develop MRD 2.5 years after treatment.
Who are they looking for?
About 360 individuals will be included. Participants for who stem cell transplant is not being considered as the first treatment option will be included. To be included females must have two negative pregnancy tests in the two weeks prior to the beginning of the study. Females must also agree to not donating eggs within the 3 months of participation ending.
Individuals who have received treatment for MM other than steroids or radiation therapy in the 2 weeks before the study will not be included. Those who have had a different form of invasive cancer in the 5 years before the study starting cannot participate.
How will it work
There will be two groups in this study. Participants in group 1 will receive the VR-d regime for 8 cycles of 21 days. This will be followed by lenalidomide-dexamethasone (Rd) until disease progression or unaccepted side effects. Participants in group 2 will receive daratumumab once every week for cycles 1 and 2, then every 3 weeks for cycle 3-8 and every 4 weeks for cycle 9 and beyond. They will also receive the VR-d regime for 9 cycles. This will be followed by daratumumab-lenalidomide-dexamethasone until disease progression or unacceptable side effects.
The percentage of patients who develop MRD will be measured. Survival will also be evaluated for up to 6 years.
