Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

February 14, 2011 updated by: Grupo de Estudos Multicentricos em Onco-Hematologia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21941913
        • Hospital Universitario Clementino Fraga Filho
      • São Paulo, Brazil
        • Santa Casa de Misericordia de Sao Paulo
    • São Paulo
      • Campinas, São Paulo, Brazil
        • Universidade Estadual De Campinas
      • Ribeirão Preto, São Paulo, Brazil
        • Universidade de São Paulo- Ribeirão Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone (Arm A)
Sixty days (D+60) after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days)
Drug: Dexamethasone
dexamethasone alone 40 mg/day for 4 days every 28 days
Other Names:
  • Decadron
  • Baycadron
  • DexPak
Experimental: Thalidomide and Dexamethasone (Arm B)

D+60 after ASCT: 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: 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.

Other Names:
  • Decadron
  • Baycadron
  • Thalomid
  • DexPak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free survival
Time Frame: 36 months
Primary endpoint: progression free survival (PFS) PFS was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months
Secondary endpoints: overall survival (OS) was defined as the interval from randomization to death (or the last follow-up for surviving patients). For patients who were not randomized, OS was calculated from the date of diagnosis until the date of death or last follow-up.
36 months
safety of thalidomide
Time Frame: 36 months
The number of patients experiencing adverse events grade 3 or 4 were compared between treatment arms. Adverse events were classified as defined by the National Cancer Institute Common Toxicity Criteria, version 2. Safety evaluations were focused especially on neurological symptoms and the development of deep venous thrombosis (DVT). Adverse events evaluations were performed at the time of response assessment and whenever a new clinical manifestation suggestive of toxicity appeared.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Estudos Multicentricos em Onco-Hematologia

Investigators

  • Principal Investigator: Angelo Maiolino, MD, PhD, Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2011

Last Update Submitted That Met QC Criteria

February 14, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBRAM0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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