Genmab Investigators Recruiting for a Phase II trial of Daratumumab in the Treatment of Multiple Myeloma

After promising results from early studies, investigators have received approval to start testing daratumumab in patients with multiple myeloma.

On September 10, 2013, representatives of Genmab A/S announced patient recruitment for phase-2 studies of daratumumab following positive results from phase-1 trials. Daratumumab is a treatment for multiple myeloma (MM).

In the coming phase-2 study, recruitment criteria indicate investigators will test daratumumab in patients with MM who have received at least 3 prior therapies in the past, including proteasome inhibitors (eg, bortezomib, carfilzomib) and immunomodulatory agents (eg, pomalidomide, lenalidomide). According to the entry for the phase-2 trial on clinicaltrials.gov, designated NCT01615029, the study will include 2 parts—the first part for patients who have MM after use of between 2 and 4 prior therapies, and the second part for patients who have a relapse of MM after having received between 1 and 3 prior therapies. Patients enrolling in the trial must be able to use dexamethasone and must be healthy enough to be active for more than half of waking hours—or healthier, designated by an EGOG status between 0 and 2. Investigators expect to recruit up to 110 patients for the 2-part study.

Daratumumab is a CD-38 monoclonal antibody with broad potential, not just in treating MM, but in treating diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, follicular lymphoma, and mantle cell lymphoma.