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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 |
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| Authors: | James R. Berenson Ori Yellin Donald Woytowitz Marshall S. Flam Alan Cartmell Ravi Patel Herb Duvivier Youram Nassir Benjamin Eades Christina DiLauro Abaya Jacqueline Hilger Regina A. Swift |
| Affiliation: | 1. Oncotherapeutics, Los Angeles, CA, USA James R. Berenson, MD, Inc., Los Angeles, CA, USA Institute for Myeloma and Bone Cancer Research, Los Angeles, CA, USA;2. Oncotherapeutics, Los Angeles, CA, USA;3. Florida Cancer Specialists, Fort Myers, FL, USA;4. Hematology/Oncology Medical Group, Fresno, CA, USA;5. Comprehensive Blood and Cancer Center, Bakersfield, CA, USA;6. James R. Berenson, MD, Inc., Los Angeles, CA, USA;7. Cedars-Sinai Medical Center, Los Angeles, CA, USA Nassir Medical Corporation, Los Angeles, CA, USA;8. Millennium Pharmaceuticals, Inc., Cambridge, MA, USA |
| Abstract: | 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/m2 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/m2 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. |
| Keywords: | multiple myeloma bortezomib ascorbic acid melphalan frontline therapy |