Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

NCT ID: NCT01296503

Last Updated: 2011-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2010-12-31

Brief 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.

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Thalidomide plus dexamethasone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Other Intervention Names

Thalomid; Baycadron; DexPak; Decadron; Baycadron; DexPak; Decadron

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo de Estudos Multicentricos em Onco-Hematologia

NETWORK

Sponsor Role: lead

Responsible Party

Universidade Federal do Rio de Janeiro

Principal Investigators

Angelo Maiolino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, Brazil

Universidade Estadual de Campinas

Campinas, São Paulo, Brazil

Universidade de São Paulo- Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

GBRAM0001

Identifier Type: -

Identifier Source: org_study_id