Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

Launched by GRUPO DE ESTUDOS MULTICENTRICOS EM ONCO-HEMATOLOGIA · Feb 14, 2011

Keywords

ClinConnect Summary

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 (...

Gender

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Eligibility 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).