Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

Grupo de Estudos Multicentricos em Onco-Hematologia

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Thalidomide plus dexamethasone; Drug: Dexamethasone

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01296503

GBRAM0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Dexamethasone (Arm A)

Active Comparator group

Description:

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)

Treatment:

Drug: Dexamethasone

Thalidomide and Dexamethasone (Arm B)

Experimental group

Description:

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.

Treatment:

Drug: Thalidomide plus dexamethasone