Thalidomide-dexamethasone Compared With Melphalan-Prednisolone in Elderly Patients With Multiple Myeloma

Blood. 2009 Apr 9;113(15):3435-42. doi: 10.1182/blood-2008-07-169565. Epub 2008 Oct 27.

Abstract

We compared thalidomide-dexamethasone (TD) with melphalan-prednisolone (MP) in 289 elderly patients with multiple myeloma (MM). Patients received either thalidomide 200 mg plus dexamethasone 40 mg, days 1 to 4 and 15 to 18 on even cycles and days 1 to 4 on odd cycles, during a 28-day cycle or to melphalan 0.25 mg/kg and prednisolone 2 mg/kg orally on days 1 to 4 during a 28- to 42-day cycle. Patients achieving stable disease or better were randomly assigned to maintenance therapy with either thalidomide 100 mg daily and 3 MU interferon alpha-2b thrice weekly or to 3 MU interferon alpha-2b thrice weekly only. TD resulted in a higher proportion of complete and very good remissions (26% vs 13%; P= .006) and overall responses (68% vs 50%; P= .002) compared with MP. Time to progression (21.2 vs 29.1 months; P= .2), and progression-free survival was similar (16.7 vs 20.7 months; P= .1), but overall survival was significantly shorter in the TD group (41.5 vs 49.4 months; P= .024). Toxicity was higher with TD, particularly in patients older than 75 years with poor performance status. The study was registered at ClinicalTrials.gov as NCT00205751.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects
  • Antineoplastic Agents, Alkylating / administration & dosage
  • Antineoplastic Agents, Alkylating / adverse effects
  • Dexamethasone / administration & dosage*
  • Dexamethasone / adverse effects
  • Disease-Free Survival
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Male
  • Melphalan / administration & dosage*
  • Melphalan / adverse effects
  • Middle Aged
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / immunology
  • Multiple Myeloma / mortality
  • Predictive Value of Tests
  • Prednisolone / administration & dosage*
  • Prednisolone / adverse effects
  • Survival Rate
  • Thalidomide / administration & dosage*
  • Thalidomide / adverse effects
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Antineoplastic Agents, Alkylating
  • Immunosuppressive Agents
  • Thalidomide
  • Dexamethasone
  • Prednisolone
  • Melphalan

Associated data

  • ClinicalTrials.gov/NCT00205751