Bortezomib, ascorbic acid and melphalan (BAM) therapy for patients with newly diagnosed multiple myeloma: an effective and well-tolerated frontline regimen

  1. James R. Berenson1,2,3,
  2. Ori Yellin1,
  3. Donald Woytowitz4,
  4. Marshall S. Flam5,
  5. Alan Cartmell5,
  6. Ravi Patel6,
  7. Herb Duvivier2,
  8. Youram Nassir7,8,
  9. Benjamin Eades2,
  10. Christina DiLauro Abaya1,
  11. Jacqueline Hilger9,
  12. Regina A. Swift2

Article first published online: 17 FEB 2009

DOI: 10.1111/j.1600-0609.2009.01244.x

Issue

European Journal of Haematology

European Journal of Haematology

Volume 82, Issue 6, pages 433–439, June 2009

Additional Information

How to Cite

Berenson, J. R., Yellin, O., Woytowitz, D., Flam, M. S., Cartmell, A., Patel, R., Duvivier, H., Nassir, Y., Eades, B., Abaya, C. D., Hilger, J. and Swift, R. A. (2009), Bortezomib, ascorbic acid and melphalan (BAM) therapy for patients with newly diagnosed multiple myeloma: an effective and well-tolerated frontline regimen. European Journal of Haematology, 82: 433–439. doi: 10.1111/j.1600-0609.2009.01244.x

Author Information

  1. 1

    Oncotherapeutics, Los Angeles, CA, USA

  2. 2

    James R. Berenson, MD, Inc., Los Angeles, CA, USA

  3. 3

    Institute for Myeloma and Bone Cancer Research, Los Angeles, CA, USA

  4. 4

    Florida Cancer Specialists, Fort Myers, FL, USA

  5. 5

    Hematology/Oncology Medical Group, Fresno, CA, USA

  6. 6

    Comprehensive Blood and Cancer Center, Bakersfield, CA, USA

  7. 7

    Cedars-Sinai Medical Center, Los Angeles, CA, USA

  8. 8

    Nassir Medical Corporation, Los Angeles, CA, USA

  9. 9

    Millennium Pharmaceuticals, Inc., Cambridge, MA, USA

*James R. Berenson, MD, Institute for Myeloma & Bone Cancer Research, 9201 W. Sunset Blvd., Suite 300, West Hollywood, CA 90069, USA. Tel: +1 310 623 1214; Fax: +1 310 623 1120; e-mail: jberenson@imbcr.org

Publication History

  1. Issue published online: 21 APR 2009
  2. Article first published online: 17 FEB 2009
  3. Accepted for publication 13 February 2009

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Keywords:

  • multiple myeloma;
  • bortezomib;
  • ascorbic acid;
  • melphalan;
  • frontline therapy

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.

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