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