SummaryMultiple myeloma (MM) typically follows a relapsing course with many patients requiring multiple therapies. This single-arm phase 2 study prospectively evaluated the efficacy and safety of bortezomib retreatment in MM patients who had relapsed after achieving at least a partial response ( ! PR) to prior bortezomib-based therapy.Patients aged ! 18 years, with measurable, secretory MM, who relapsed ! 6 months after prior bortezomib treatment were eligible. Patients received up to eight cycles of bortezomib (AEdexamethasone). The primary endpoint was best confirmed response at retreatment; secondary endpoints included duration of response (DOR), time to progression (TTP), and safety. Adverse events (AEs) were graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.A total of 130 patients (median of two prior lines of therapy) were enrolled and received retreatment. At retreatment, 28% and 72% of patients received bortezomib and bortezomib-dexamethasone, respectively. Overall response rate was 40%. In patients who achieved ! PR, median DOR and TTP were 6Á5 and 8Á4 months, respectively. Thrombocytopenia was the most common grade ! 3 AE (35%). Forty percent of patients experienced neuropathy events, which improved and resolved in a median of 1Á5 and 8Á9 months, respectively.In conclusion, bortezomib retreatment was effective and tolerable in relapsed MM patients, with no evidence of cumulative toxicities.Keywords: bortezomib, multiple myeloma, phase 2, relapsed, retreatment.

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These findings support bortezomib retreatment after a treatment-free interval of ≥6 months in patients who achieved at least a partial response to the first-line bortezomib-based therapy.

This prospective, open-label, multicenter study was undertaken to determine the safety and efficacy of epoetin alfa in increasing hemoglobin levels and improving quality of life (QOL), specifically fatigue, in cancer patients receiving chemotherapy with or without radiotherapy (n = 702). Epoetin alfa, 10,000 IU three times a week s.c. for 8-18 weeks, increased the mean hemoglobin level relative to baseline (1.0 ± 1.5 g/dl by week 4 and ≥1.7 g/dl from week 10 through the end of the trial), with 63.4% of patients experiencing ≥2 g/dl increases in hemoglobin above baseline at some time during the study. Fatigue is an important component of QOL. Physicians, nurses, and patients independently assessed patient fatigue level on a linear-analogue scale. Although all three groups reported improvements in patient fatigue over the course of the study (p < .0001), the magnitude of fatigue ratings and their relationship to tumor response and to hemoglobin level varied by group. Overall, epoetin alfa was well tolerated and effective in improving hemoglobin levels and decreasing fatigue in patients undergoing chemotherapy. The Oncologist 2005;10:225-237 The Oncologist 2005;10:225-237 www.TheOncologist.com