The phase III trial will compare daratumumab in combination with bortezomib, melphalan and prednisone to bortezomib, melphalan and prednisone alone as front line treatment for patients who are not considered candidates for stem cell transplantation (SCT).
Genmab chief executive officer Jan van de Winkel said the company is happy to announce the plans for the third Phase III trial of daratumumab.
"The robust development program we designed jointly with Janssen continues moving forward rapidly," Winkel said.
The trial will include about 700 newly diagnosed, chemotherapy naïve multiple myeloma patients ineligible for stem cell transplantation (SCT).
In the trial, patients will be randomized to receive either daratumumab combined with bortezomib, melphalan and prednisone (a corticosteroid), or bortezomib, melphalan and prednisone alone.
The primary endpoint of the randomized, open-label, multicenter phase III trial is progression free survival (PFS).
Bortezomib is a unique type of chemotherapy, called a proteasome inhibitor (PI), while melphalan is an alkylating chemotherapeutic agent.
Image: Bone marrow aspirate showing the histologic correlate of plasma cell myeloma under the microscope. Photo: courtesy of KGH