Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.
Full description
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity.
NOTE: *For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only.
Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Newly diagnosed Salmon-Durie stage II or III multiple myeloma
Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)
No evidence of cord compression requiring concurrent steroids
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior bortezomib
More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks
No steroids within 14 days prior to study entry
No concurrent corticosteroids except for the treatment of a nonmalignant condition
No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery
No other concurrent investigational agents
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal