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| A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma |
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| Author(s): Jagannath S, Barlogie B, Berenson J, Siegel D, Irwin D, Richardson PG, Niesvizky R, Alexanian R, Limentani SA, Alsina M, Adams J, Kauffman M, Esseltine DL, Schenkein DP, Anderson KC |
| Source: BRITISH JOURNAL OF HAEMATOLOGY Volume: 127 Issue: 2 Pages: 165-172 Published: OCT 2004 |
| Times Cited: 265 References: 16 |
| Abstract: In a phase 2 open-label study of the novel proteasome inhibitor bortezomib, 54 patients with multiple myeloma who had relapsed after or were refractory to frontline therapy were randomized to receive intravenous 1.0 or 1.3 mg/m(2) bortezomib twice weekly for 2 weeks, every 3 weeks for a maximum of eight cycles. Dexamethasone was permitted in patients with progressive or stable disease after two or four cycles respectively. Responses were determined using modified European Group for Blood and Marrow Transplantation criteria. The complete response (CR) + partial response (PR) rate for bortezomib alone was 30% [90% confidence interval (CI), 15.7-47.1] and 38% (90% CI, 22.6-56.4) in the 1.0 mg/m(2) (8 of 27 patients) and 1.3 mg/m(2) (10 of 26 patients) groups respectively. The CR + PR rate for patients who received bortezomib alone or in combination with dexamethasone was 37% and 50% for the 1.0 and 1.3 mg/m(2) cohorts respectively. The most common grade 3 adverse events were thrombocytopenia (24%), neutropenia (17%), lymphopenia (11%) and peripheral neuropathy (9%). Grade 4 events were observed in 9% (five of 54 patients). Bortezomib alone or in combination with dexamethasone demonstrated therapeutic activity in patients with multiple myeloma who relapsed after frontline therapy. |
| Document Type: Article |
| Language: English |
| Reprint Address: Jagannath, S (reprint author), St Vincents Comprehens Canc Ctr, 325 W 15th St, New York, NY 10011 USA |
Addresses:
1. St Vincents Catholic Med Ctr, New York, NY USA
2. Univ Arkansas, Little Rock, AR 72204 USA
3. Inst Myeloma & Bone Canc Res, W Hollywood, CA USA
4. Hackensack Univ Med Ctr, Hackensack, NJ USA
5. Alta Bates Comprehens Canc Ctr, Berkeley, CA USA
6. Dana Farber Canc Inst, Boston, MA 02115 USA
7. Cornell Univ, New York Presbyterian Hosp, Weill Med Coll, New York, NY USA
8. Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA
9. Carolinas Hematol Oncol Associates, Charlotte, NC USA
10. Univ S Florida, H Lee Moffitt Canc Ctr, Tampa, FL 33682 USA
11. Infin Pharmaceut Inc, Cambridge, MA USA
12. Predix Pharmaceut Inc, Woburn, MA USA
13. Millennium Pharmaceut Inc, Cambridge, MA USA |
| Publisher: BLACKWELL PUBLISHING LTD, 9600 GARSINGTON RD, OXFORD OX4 2DG, OXON, ENGLAND |
| Subject Category: Hematology |
| IDS Number: 859QT |
| ISSN: 0007-1048 |
| DOI: 10.1111/j.1365-2141.2004.05188.x |
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