Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

Criteria

Inclusion Criteria:

• symptomatic multiple myeloma in accordance with the International Myeloma Working Group criteria;

• age 18-70 years;

• Performance status 0-2 by the Eastern Cooperative Oncology Group (ECOG) criteria;

• normal hepatic function, defined as serum bilirubin <3 mg/dl and alanine aminotransferase(ALT) and asparagin aminotransferase (AST) <4x normal.

Exclusion Criteria:

• evidence of disease progression after ASCT;

• cardiac dysfunction (systolic ejection fraction <50%);

• chronic respiratory disease (carbon monoxide diffusion <50% of normal).