Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov Identifier:
NCT01296503
First received: January 27, 2011
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide plus dexamethasone
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial

Resource links provided by NLM:


Further study details as provided by Grupo de Estudos Multicentricos em Onco-Hematologia:

Primary Outcome Measures:
  • Progression Free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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.

  • safety of thalidomide [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 213
Study Start Date: October 2003
Study Completion Date: December 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Baycadron
  • DexPak
  • Decadron
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:
  • Thalomid
  • Baycadron
  • DexPak
  • Decadron

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296503

Locations
Brazil
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Universidade de São Paulo- Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Brazil, 21941913
Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Grupo de Estudos Multicentricos em Onco-Hematologia
Investigators
Principal Investigator: Angelo Maiolino, MD, PhD Universidade Federal do Rio de Janeiro
  More Information

No publications provided

Responsible Party: Angelo Maiolino, MD, PhD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01296503     History of Changes
Other Study ID Numbers: GBRAM0001
Study First Received: January 27, 2011
Last Updated: February 14, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Grupo de Estudos Multicentricos em Onco-Hematologia:
Multiple Myeloma
Treatment
Maintenance
Thalidomide

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on September 16, 2014