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news.Millennium Pharmaceuticals has reported positive Phase I data from a randomized, multi-center, company-sponsored Phase I/II study of Velcade, dexamethasone, cyclophosphamide and lenalidomide in patients with previously untreated multiple myeloma.
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The preliminary analysis of the safety data showed that the combination of four drugs was generally well tolerated in patients who had received no prior therapies and response rates were encouraging.
This trial, called Evolution, builds on positive results from previous studies of Velcade based combinations in this setting. The reported data was the first clinical data with the novel four-drug combination. The safety results allow the trial to proceed to Phase II, which will randomize patients to receive VcDR, VcDC or Velcade, dexamethasone, cyclophosphamide and lenalidomide (VcDCR).
Results from the 25 patients treated in this trial with VcDCR for a median of four cycles (range: 2-11 cycles), showed that the maximum tolerated dose of cyclophosphamide in the VcDCR regimen was not reached. The recommended doses for the Phase II portion of the trial include 500mg/m(2) of cyclophosphamide, the highest planned dose, 1.3 mg/m(2) of Velcade, 40mg of dexamethasone and 15mg of lenalidomide.
During Phase I, patients received Velcade at 1.3 mg/m(2) on days one, four, eight and 11 on a 21-day cycle for up to eight cycles; dexamethasone at 40mg on days one, eight and 15; lenalidomide at 15mg on days one through 14; and cyclophosphamide at 100, 200, 300, 400 or 500 mg/m(2) on days one and eight for up to eight 21-day cycles. This was followed by Velcade at 1.3mg/m(2) on days one, eight, 15 and 22 for four 42-day maintenance cycles.
The primary endpoint of this Phase I trial was the determination of the maximum tolerated dose of cyclophosphamide in combination with VcDR. The primary endpoints of the ongoing Phase II portion of the trial are complete response and very good partial response rates, while the secondary endpoints include progression-free survival, overall survival, safety and tolerability.
Nancy Simonian, chief medical officer of Millennium, said: We are committed to advancing multiple myeloma treatment that delivers the best patient outcomes. The tolerability of this novel four-drug combination allows us to study its efficacy relative to two of the most active three-drug regimens for previously untreated multiple myeloma patients.