A Phase II Study of Maintenance Treatment With Sequential Bortezomib, Thalidomide and Dexamethasone Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Multiple Myeloma
OBJECTIVES:
Primary
- To assess the feasibility and toxicities of maintenance therapy with sequential
bortezomib, thalidomide, and dexamethasone after high-dose melphalan and autologous
peripheral blood stem cell transplantation in patients with multiple myeloma.
- To assess whether administration of sequential bortezomib, thalidomide, and
dexamethasone can improve progression-free survival of these patients.
Secondary
- To assess whether administration of sequential bortezomib, thalidomide, and
dexamethasone can increase complete remission rate and duration of response in these
patients.
- To assess the impact of maintenance therapy with sequential bortezomib, thalidomide,
and dexamethasone after transplantation on overall survival of these patients.
- To evaluate the influence of cytogenetic abnormalities (e.g., chromosome 13 deletion,
14 q32 abnormality, t [4;14], chromosome 1 q21 amplification, and chromosome 17
deletion) on outcome by performing conventional cytogenetic study and fluorescence in
situ hybridization (FISH) studies on baseline and post-transplant bone marrow
specimens.
OUTLINE:
- High-dose melphalan and autologous peripheral blood stem cell transplantation (PBSCT):
Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo
autologous PBSCT on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously
beginning on day 5 and continuing until blood counts recover.
- Maintenance therapy: Beginning 4-8 weeks after transplantation, patients receive
bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in
the absence of disease progression or unacceptable toxicity. Patients also receive oral
dexamethasone on days 1-4; treatment with dexamethasone repeats every month for 12
months in the absence of disease progression or unacceptable toxicity. Beginning 2
weeks after completion of bortezomib, patients receive oral thalidomide once daily
until disease progression.
Patients complete the FACT-GOG neurotoxicity questionnaire periodically. Bone marrow samples
are collected at baseline and post-transplant for cytogenetic analysis by FISH.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and toxicities of maintenance therapy
After 4 months of maintenance therapy
Yes
Firoozeh Sahebi, MD
Principal Investigator
City of Hope Medical Center
United States: Institutional Review Board
06143
NCT00792142
January 2008
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |