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Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

Information source: Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Thalidomide plus dexamethasone (Drug); Dexamethasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Grupo de Estudos Multicentricos em Onco-Hematologia

Official(s) and/or principal investigator(s):
Angelo Maiolino, MD, PhD, Principal Investigator, Affiliation: Universidade Federal do Rio de Janeiro


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.

Clinical Details

Official title: Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free survival

Secondary outcome:

Overall survival

safety of thalidomide

Detailed description: Patients were recruited prior to receiving induction therapy, and randomization in a 1: 1 ratio occurred on day 60 post-autologous stem cell transplantation. The treatment consisted of the following four phases: 1. induction with 3-5 cycles of vincristine plus doxorrubicin and dexamethasone (VAD) every 21-28 days: vincristine 0. 4 mg , doxorubicin 9 mg/m² and oral dexamethasone 40 mg daily for 4 days; 2. cyclophosphamide (4 g/m2 ) plus filgrastim (G-CSF) (5 μg/kg twice a day) for stem cell mobilization; 3. melphalan (200 mg/m2 ) and one autologous stem cell transplant (ASCT); 4. Sixty days (D +60) after ASCT: RANDOMIZATION in two arms of maintenance: Arm A (oral dexamethasone alone 40 mg/d for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg daily by mouth) for 12 months or until disease progression.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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).

Locations and Contacts

Hospital Universitário Clementino Fraga Filho, Rio de Janeiro 21941913, Brazil

Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil

Universidade Estadual de Campinas, Campinas, São Paulo, Brazil

Universidade de São Paulo- Ribeirão Preto, Ribeirão Preto, São Paulo, Brazil

Additional Information

Starting date: October 2003
Last updated: February 14, 2011

Page last updated: August 23, 2015

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