Daratumumab + Len/Dex shows ORR in relapsed/refractory multiple myeloma phase 1/2 trial

This completed phase 1/2 study, sponsored by Janssen Research & Development, LLC, aimed to establish the safety profile of daratumumab in combination with lenalidomide and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma. The study enrolled 45 participants and was conducted in two parts. Part 1 was a dose escalation portion where participants were enrolled into cohorts at increasing dose levels of daratumumab in combination with lenalidomide and dexamethasone across 28-day treatment cycles. Part 2 was a cohort expansion portion designed to further explore the maximum tolerated dose (or the maximum tested dose) of daratumumab as determined in Part 1. The primary outcome measure for both Phase 1 and Phase 2 was the percentage of participants achieving an overall response rate. The study started on June 26, 2012, with primary completion on October 2, 2015, and results were posted on April 14, 2017. The abstract does not report specific numerical results for the overall response rate, safety data, or the determined maximum tolerated dose.

For people living with multiple myeloma—a blood cancer—one of the hardest moments is when the disease returns after treatment. This is called relapsed or relapsed-refractory myeloma. This study asked a direct question: is a new three-drug combination safe and does it work for these patients? The treatment combined daratumumab (a targeted antibody drug) with two existing drugs, lenalidomide and dexamethasone. The study was done in two parts. First, researchers carefully tested increasing doses of daratumumab to find the safest, highest dose to use. Then, they expanded the trial to further explore that dose. The main goal was to see how many patients responded to the treatment, which is measured by the Overall Response Rate. The study enrolled 45 patients to answer these questions. The findings from this trial help doctors understand if this specific combination is a viable option for people who have run out of other treatments, offering a potential new direction when the cancer comes back.