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In August 2016, Antonio Palumbo from the Department of Hematology in Turin, Italy, and a wide group of collaborators, published the findings of the CASTOR clinical trial - to assess the efficacy of daratumumab on a background treatment of bortezomib and dexamethasone – in the New England Journal of Medicine. This study built upon the previous success of daratumumab as a monotherapy in patients with newly diagnosed multiple myeloma (NDMM). In the CASTOR phase 3, open-label trial, 498 patients with relapsed or relapsed and refractory MM, were recruited between September 2014 and September 2015, at 115 centers in 16 countries. The primary end point was progression free survival (PFS); secondary end points were time to disease progression (TTP), overall response (OR) rate, the proportion of patients who achieved very good partial response (PR) or better and duration of response, time to response, and overall survival (OS).
Distinct benefits in PFS were observed for the use of daratumumab in combination with bortezomib and dexamethasone (61.4% reduction in risk of disease progression), compared to treatment with bortezomib and dexamethasone alone. Responses were durable, extended into the next treatment phase and gave patients longer periods of remission. In general, daratumumab was associated with higher rates of thrombocytopenia and neutropenia and reactions to the infusion (usually for the first dose), but overall was well tolerated. This was similar to the POLLUX https://clinicaltrials.gov/ct2/show/NCT02076009 study, which assessed the efficacy of daratumumab in a triple therapy regimen with a backbone of bortezomib and dexamethasone (see MM Hub article). Data from this study led to a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the use of daratumumab in combination with bortezomib and dexamethasone, for the treatment of adult patients with MM who have received at least one prior therapy. This extended the previously approved indication for use as a monotherapy in RRMM patients, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and demonstrated disease progression on the last therapy.
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