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- Title
High response rate to bortezomib with or without dexamethasone in patients with relapsed or refractory multiple myeloma: results of a global phase 3b expanded access program.
- Authors
Mikhael, Joseph R.; Belch, Andrew R.; Prince, H. Miles; Lucio, Maria Nambo; Maiolino, Angelo; Corso, Alessandro; Petrucci, Maria Teresa; Musto, Pellegrino; Komarnicki, Mieczyslaw; Stewart, A. Keith
- Abstract
Phase 2 trials have demonstrated that bortezomib ± dexamethasone is safe and effective in relapsed multiple myeloma (MM). In this multicentre, open-label, phase 3b trial, 638 patients with relapsed or refractory MM (median 3 prior therapies) received bortezomib 1·3 mg/m2 on days 1, 4, 8, and 11 of a maximum of eight 3-week cycles (median 5 cycles). Dexamethasone 20 mg/d was added the day of and day after each bortezomib dose for progressive disease after ≥2 cycles or for stable disease after ≥4 cycles. Responses were assessed based on M-protein changes. Overall response rate was 67%, including 11% complete (100% M-protein reduction), 22% very good partial (75–99% reduction), 18% partial (50–74% reduction), and 16% minimal response (25–49% reduction). Dexamethasone was added in 208 patients (33%), of whom 70 (34%) showed improved response. Median time to best response of minimal response or better was 84 d. Most common grade 3/4 adverse events were thrombocytopenia (39%), neutropenia (16%), anaemia (12%), diarrhoea (7%), and peripheral neuropathy (6%). Neuropathy (any grade) was seen in 25% of the patients and led to discontinuation in 5%. Bortezomib, alone and combined with dexamethasone, is safe and effective in heavily pretreated patients with relapsed or refractory MM.
- Subjects
MYELOMA proteins; NEUROPATHY; ANEMIA; BLOOD diseases; THROMBOCYTOPENIA; MULTIPLE myeloma
- Publication
British Journal of Haematology, 2009, Vol 144, Issue 2, p169
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/j.1365-2141.2008.07409.x