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Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

NCT01296503 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2011-02-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Thalidomide plus dexamethasone

D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression. The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.

DRUG

Dexamethasone

dexamethasone alone 40 mg/day for 4 days every 28 days

Sponsors & Collaborators

  • Grupo de Estudos Multicentricos em Onco-Hematologia

    lead NETWORK

Principal Investigators

  • Angelo Maiolino, MD, PhD · Universidade Federal do Rio de Janeiro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-07-31
Completion
2010-12-31

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01296503 on ClinicalTrials.gov