DETERMINATION
DETERMINATION asked whether people with newly diagnosed myeloma still need a stem-cell transplant when modern three-drug therapy and long maintenance are available; transplant kept the disease away for longer, but after several years the two groups had not lived different lengths of time, so the transplant can be delayed for some.
Overview
DETERMINATION (DFCI 10-106) was a US phase 3 trial in transplant-eligible newly diagnosed multiple myeloma. Patients received three cycles of lenalidomide, bortezomib and dexamethasone (RVd) and were then randomised to high-dose melphalan with autologous stem-cell transplant followed by two more RVd cycles, or to five more RVd cycles without transplant. Both arms went on to lenalidomide maintenance until progression, which distinguished it from the parallel French IFM 2009 trial that capped maintenance at one year.
Progression-free survival, the primary endpoint, was significantly longer with early transplant. Overall survival did not differ at the time of the primary report, in part because many patients in the no-transplant arm received a transplant at relapse. The trial supports early transplant as the standard but also a deferred transplant strategy for selected patients.
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