Multiple Myeloma Clinical Trial
Official title:
S0417 A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune
system in different ways and stop cancer cells from growing. It may also stop the growth of
cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as
dexamethasone, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and
dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide
and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.
OBJECTIVES:
- Determine the confirmed overall response rate (complete remission, remission, and
partial remission) in patients with relapsed or refractory multiple myeloma treated with
bortezomib, thalidomide, and dexamethasone.
- Determine overall and progression-free survival of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Correlate, preliminarily, treatment with bortezomib with the activation of osteoblasts
in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral
thalidomide once daily on days 1-21, and oral dexamethasone once daily on days 1, 2, 4,
5, 8, 9, 11, and 12. Treatment repeats every 21 days until achievement of confirmed
complete remission (CR), remission (R), or partial remission (PR) OR for up to 8 courses
in the absence of disease progression or unacceptable toxicity.
Patients achieving confirmed CR, R, or PR who reach a plateau prior to receiving the maximum
8 courses of induction therapy OR who achieve confirmed CR, R, or PR after receiving the
maximum 8 courses of induction therapy proceed to maintenance therapy. Patients achieving
stable disease after receiving the maximum 8 courses of induction therapy either proceed to
maintenance therapy or receive further treatment with bortezomib, thalidomide, and
dexamethasone off-study.
- Maintenance therapy: Patients receive oral dexamethasone on days 1-4. Courses repeat
every 28 days for up to 3 years in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed within 30 days and then every 6
months for up to 5 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
;
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