Arandomized phase 3 trial of thalidomide and prednisone as maintenance therapy afterASCT in patients withMMwith a quality-of-life assessment: The national cancer Institute of Canada clinicals trials group myeloma 10 trial

A. Keith Stewart, Suzanne Trudel, Nizar J. Bahlis, Darrell White, Waleed Sabry, Andrew Belch, Tony Reiman, Jean Roy, Chaim Shustik, Michael J. Kovacs, Morel Rubinger, Guy Cantin, Kevin Song, Kirsty A. Tompkins, Deb C. Marcellus, Martha Q. Lacy, Jonathan Sussman, Donna Reece, Michael Brundage, Erica L. HarnettLois Shepherd, Judy Anne W. Chapman, Ralph M. Meyer

Research output: Contribution to journalArticle

100 Scopus citations

Abstract

We conducted a randomized, controlled trial comparing thalidomide- prednisone as maintenance therapy with observation in 332 patients who had undergone autologous stem cell transplantation with melphalan 200 mg/m2. The primary end point was overall survival (OS); secondary end points were myeloma-specific progression-free survival, progression-free survival, incidence of venous thromboembolism, and health-related quality of life (HRQoL). With a median follow-up of 4.1 years, no differences in OS between thalidomide- prednisone and observation were detected (respective 4-year estimates of 68% vs 60%, respectively; hazard ratio = 0.77; P = .18); thalidomide-prednisone was associated with superior myeloma-specific progression-free survival and progression-free survival (for both outcomes, the 4-year estimates were 32% vs 14%; hazard ratio = 0.56; P < .0001) and more frequent venous thromboembolism (7.3% vs none; P = .0004). Median survival after first disease recurrence was 27.7 months with thalidomide-prednisone and 34.1 months in the observation group. Nine second malignancies were observed with thalidomide-prednisone versus 6 in the observation group. Those allocated to thalidomideprednisone reported worse HRQoL with respect to cognitive function, dyspnea, constipation, thirst, leg swelling, numbness, dry mouth, and balance problems. We conclude that maintenance therapy with thalidomide-prednisone after autologous stem cell transplantation improves the duration of disease control, but is associated with worsening of patient-reported HRQoL and no detectable OS benefit.

Original languageEnglish (US)
Pages (from-to)1517-1523
Number of pages7
JournalBlood
Volume121
Issue number9
DOIs
StatePublished - Feb 28 2013

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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    Stewart, A. K., Trudel, S., Bahlis, N. J., White, D., Sabry, W., Belch, A., Reiman, T., Roy, J., Shustik, C., Kovacs, M. J., Rubinger, M., Cantin, G., Song, K., Tompkins, K. A., Marcellus, D. C., Lacy, M. Q., Sussman, J., Reece, D., Brundage, M., ... Meyer, R. M. (2013). Arandomized phase 3 trial of thalidomide and prednisone as maintenance therapy afterASCT in patients withMMwith a quality-of-life assessment: The national cancer Institute of Canada clinicals trials group myeloma 10 trial. Blood, 121(9), 1517-1523. https://doi.org/10.1182/blood-2012-09-451872