Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: Randomised controlled trial

Antonio Palumbo, Sara Bringhen, Tommaso Caravita, Emanuela Merla, Vincenzo Capparella, Vincenzo Callea, Clotilde Cangialosi, Mariella Grasso, Fausto Rossini, Monica Galli, Lucio Catalano, Elena Zamagni, Maria Teresa Petrucci, Valerio De Stefano, Manuela Ceccarelli, Maria Teresa Ambrosini, Ilaria Avonto, Patrizia Falco, Giovannino Ciccone, Anna Marina LiberatiPellegrino Musto, Mario Boccadoro

Research output: Contribution to journalArticle

Abstract

Background: Since 1960, oral melphalan and prednisone (MP) has been regarded as the standard of care in elderly multiple myeloma patients. This multicentre randomised trial compared oral MP plus thalidomide (MPT) with MP alone in patients aged 60-85 years. Methods: Patients with newly diagnosed multiple myeloma were randomly assigned to receive oral MP for six 4-week cycles plus thalidomide (n=129; 100 mg per day continuously until any sign of relapse or progressive disease) or MP alone (n=126). Analysis was intention-to-treat. This study is registered at ClinicalTrial.gov, number NCT00232934. Results: Patients treated with thalidomide had higher response rates and longer event-free survival (primary endpoints) than patients who were not. Combined complete or partial response rates were 76.0% for MPT and 47.6% for MP alone (absolute difference 28.3%, 95% CI 16.5-39.1), and the near-complete or complete response rates were 27.9% and 7.2%, respectively. 2-year event-free survival rates were 54% for MPT and 27% for MP (hazard ratio [HR] for MPT 0.51, 95% CI 0.35-0.75, p=0.0006). 3-year survival rates were 80% for MPT and 64% for MP (HR for MPT 0.68, 95% CI 0.38-1.22, p=0.19). Rates of grade 3 or 4 adverse events were 48% in MPT patients and 25% in MP patients (p=0.0002). Introduction of enoxaparin prophylaxis reduced rate of thromboembolism from 20% to 3% (p=0.005). Conclusion: Oral MPT is an effective first-line treatment for elderly patients with multiple myeloma. Anticoagulant prophylaxis reduces frequency of thrombosis. Longer follow-up is needed to assess effect on overall survival.

Original languageEnglish
Pages (from-to)825-831
Number of pages7
JournalLancet
Volume367
Issue number9513
DOIs
Publication statusPublished - Mar 11 2006

ASJC Scopus subject areas

  • Medicine(all)

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    Palumbo, A., Bringhen, S., Caravita, T., Merla, E., Capparella, V., Callea, V., Cangialosi, C., Grasso, M., Rossini, F., Galli, M., Catalano, L., Zamagni, E., Petrucci, M. T., De Stefano, V., Ceccarelli, M., Ambrosini, M. T., Avonto, I., Falco, P., Ciccone, G., ... Boccadoro, M. (2006). Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: Randomised controlled trial. Lancet, 367(9513), 825-831. https://doi.org/10.1016/S0140-6736(06)68338-4