Clinical trial NCT01296503: Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma
Official title: Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Treatment
Maintenance
Thalidomide
Lead sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia
Sponsor class: NETWORK
First posted: 2011-02-15
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Progression Free survival
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: safety of thalidomide
timeFrame: 36 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Universidade de São Paulo- Ribeirão Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
city: São Paulo
country: Brazil
facility: Santa Casa de Misericórdia de São Paulo
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Angelo Maiolino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: