PS 341 (Velcade) plus thalidomide for posttransplantation relapse in 46 patients. PS 341 was administered at a dose of 1 mg/m2 on days 1, 4, 8, and 11 of each cycle, repeated every 21 days. Thalidomide was added with the start of the second cycle of PS 341 at a daily starting dose of 50 mg (12 patients) with increases to 100 mg (10 patients), 150 mg (11 patients), and 200 mg (13 patients) in the subsequent cohorts. Thalidomide dose increments were implemented whenever at least 7 patients had completed cycle number 2 at the lower thalidomide dose level without neuropathy greater than grade 2. (A) Cumulative incidence, on an intent-to-treat basis, by different levels of myeloma protein reduction. Response ensued so quickly that 60% had achieved a partial response (PR; ≥ 50% M-protein reduction) at the end of cycle 3. Near-CR (> 99% reduction; only immunofixation revealed monoclonal protein) was noted in 20% to 30%. Overall survival (B) and event-free survival (C) are portrayed by using Kaplan-Meier plots, related to presence of cytogenetic abnormalities (CA). Superior survival was observed in the absence of CA (no CA), whereas patients with CA 13/hypodiploid or other CA had a poor prognosis (Figure 3 legend).
