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Bortezomib, ascorbic acid and melphalan (BAM) therapy for patients with newly diagnosed multiple myeloma: an effective and well‐tolerated frontline regimen
Author(s) -
Berenson James R.,
Yellin Ori,
Woytowitz Donald,
Flam Marshall S.,
Cartmell Alan,
Patel Ravi,
Duvivier Herb,
Nassir Youram,
Eades Benjamin,
Abaya Christina DiLauro,
Hilger Jacqueline,
Swift Regina A.
Publication year - 2009
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/j.1600-0609.2009.01244.x
Subject(s) - medicine , bortezomib , multiple myeloma , neutropenia , regimen , melphalan , ascorbic acid , surgery , adverse effect , gastroenterology , thalidomide , phases of clinical research , chemotherapy , chemistry , food science
Background: We conducted a single‐arm, multicentre phase 2 study to evaluate bortezomib, ascorbic acid and melphalan (BAM) for patients with newly diagnosed multiple myeloma (MM). Methods: Induction consisted of up to eight 28‐d cycles of bortezomib 1.0 mg/m 2 on days 1, 4, 8 and 11, plus oral ascorbic acid 1 g and oral melphalan 0.1 mg/kg on days 1–4, followed by maintenance bortezomib 1.3 mg/m 2 every 2 wk until progression. Results: Among 35 patients enrolled (median age 70 yr), responses occurred in 23/31 evaluable patients (74%) including five (16%) complete, three (10%) very good partial, six (19%) partial and nine (29%) minimal responses. Six patients (19%) had stable disease. Thus, disease control was achieved in 29 (94%) patients. Median times to first and best responses were 2 and 3 months (ranges 1–5 and 1–7), respectively. Median time to progression was 19 months and median overall survival has not been reached (range 2–23+ months). Grade 3 and 4 adverse events occurred in 17 and 5 patients, respectively; the most common were neutropenia, neuropathy and thrombocytopenia. Conclusions: BAM is an efficacious, well‐tolerated and steroid‐ and immunomodulatory drug (IMiD)‐free frontline treatment regimen for MM patients.