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Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial


Phase 3
18 Years
70 Years
Not Enrolling
Both
Multiple Myeloma

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Trial Information

Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free survival

Outcome Description:

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.

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Angelo Maiolino, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Federal University of Rio de Janeiro

Authority:

Brazil: Ethics Committee

Study ID:

GBRAM0001

NCT ID:

NCT01296503

Start Date:

October 2003

Completion Date:

December 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Treatment
  • Maintenance
  • Thalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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