It will be a large trial, including about 480 relapsed / refractory patients.
For patients who might be interested in participating in the trial, the primary downside is that this will be a randomized trial, meaning not all patients will receive the three-drug combination. Instead, patients will be randomly selected to receive either
- Daratumumab, Velcade, and dexamethasone, or
- Velcade and dexamethasone
No information about the trial is available yet at clinicaltrials.gov. Here, however, is a bit more detail from the Genmab press release:
Genmab A/S (OMX: GEN) announced today that its partner, Janssen Biotech, Inc. ("Janssen") will start a Phase III study of daratumumab in relapsed or refractory multiple myeloma. The study will compare daratumumab in combination with bortezomib and dexamethasone to bortezomib and dexamethasone alone.
"We have now announced plans for two Phase III studies of daratumumab in combination with the most common approved treatments for multiple myeloma. We believe that adding daratumumab to treatment regimens containing bortezomib, and lenalidomide, respectively, could potentially improve treatment outcomes for patients suffering from multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study
This Phase III study will include approximately 480 patients who have relapsed or refractory multiple myeloma. Patients will be randomized to receive either daratumumab combined with bortezomib (a unique type of chemotherapy, called a proteasome inhibitor) and dexamethasone (a corticosteroid), or bortezomib and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).
