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

January 27, 2011
February 14, 2011
October 2003
July 2008   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01296503 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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
  • Drug: Dexamethasone
    dexamethasone alone 40 mg/day for 4 days every 28 days
    Other Names:
    • Baycadron
    • DexPak
    • Decadron
  • 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)
    Intervention: Drug: Dexamethasone
  • 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.

    Intervention: Drug: Thalidomide plus dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
December 2010
July 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01296503
GBRAM0001
Yes
Angelo Maiolino, MD, PhD, Universidade Federal do Rio de Janeiro
Grupo de Estudos Multicentricos em Onco-Hematologia
Not Provided
Principal Investigator: Angelo Maiolino, MD, PhD Universidade Federal do Rio de Janeiro
Grupo de Estudos Multicentricos em Onco-Hematologia
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP