Date: 2014-11-10
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Janssen Biotech - J&J (USA - NY), French Intergroup of Myeloma (IFM) (France), Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) (Belgium - The Netherlands
Product: daratumumab in combination with bortezomib, thalidomide and dexamethasone
Action
mechanism: monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD.
Disease: frontline multiple myeloma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: MMY3006 is a randomized, open-label, multicenter, Phase III study and will include approximately 1,000 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients will be randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint of this part of the study is the number of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo a second randomization to either receive daratumumab maintenance treatment for a maximum of 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).
Latest
news: * On November 10, 2014, Genmab announced that the French Intergroup of Myeloma (IFM) in collaboration with Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Biotech plans to start an additional Phase III study of daratumumab in frontline multiple myeloma. The study (MMY3006) will compare daratumumab in combination with bortezomib, thalidomide and dexamethasone (VTD) to bortezomib, thalidomide and dexamethasone alone as front line treatment for patients who are candidates for stem cell transplantation (SCT). The study is planned to start in Q2 2015. The first Phase III study in front line multiple myeloma was announced in July and is expected to start towards the end of this year, with the two other Phase III front line studies to start next year (NCT02195479, NCT02076009,NCT02136134, NCT02252172) . In total today's news is the fifth daratumumab Phase III study to be announced.
