Evaluating the addition of daratumumab to RVd treatment for newly diagnosed multiple myeloma.

This trial was carried out to look at how safe and effective the addition of daratumumab (Darzalex) would be to the RVd regimen involving lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (Decadron) in the treatment of patients with newly diagnosed multiple myeloma (MM). The authors found that D-RVd had a better response when compared to patients who received RVd alone in these patients.

MM is a form of cancer that comes from a type of white blood cells called a plasma cell. Symptoms of MM include bone pain, nausea, and fatigue. Despite current treatment options, MM remains uncurable. The current treatment for MM involves treatment with RVd followed by a transplant of healthy bone marrow.  

Daratumumab is an immune therapy that function by binding to a protein called CD38 found in high numbers on MM cells. It activates the immune system to attack and kill cancer cells. Previous studies have shown that daratumumab-based regimens have improved responses in patients with MM. However, the addition to daratumumab to the RVd regimen in patients who are eligible for a stem cell transplant has not been evaluated.  

There were 207 patients with newly diagnosed MM enrolled in this trial. Group 1 received D-RVd treatment (104 patients) and group 2 received RVd treatment (103 patients). Patients then has a stem cell transplant followed by consolidation treatment with either D-RVd (group 1) or RVd (group 2). Consolidation treatment is meant to kill any cancer cells left after initial treatment. After consolidation treatment, patients received maintenance (treatment meant to keep the cancer from returning) with lenalidomide alone (group 2) or lenalidomide and daratumumab (group 1). Follow-up for patients was on average 22.1 months. 

More patients in group 1 achieved a complete response (CR) compared to group 2 (42.4% vs 32%) after 13.5 months. With a longer follow-up of 22.1 months, a CR was achieved by 62.6% in group 1 compared to 45.4% in group 2.

Minimal residual disease (MRD) is the small number of cells that may remain after cancer treatment. MRD positive patients may be at risk for relapse. More patients in group 1 were MRD negative (51%) compared to group 2 (20.4%). 

16.3% of patients in the D-RVd group stopped the study treatment compared to 42.7% of the RVd group. The most common reasons for stopping treatment were disease progression, withdrawal from the study, or side effects.

The authors found that D-RVd was safe and improved the response in patients with newly diagnosed MM when compared to RVd. 

This trial was sponsored by Janssen, the manufacturers of daratumumab.