A Phase 2 interventional study of bortezomib in Lymphoma, sponsored by NCIC Clinical Trials Group. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-17.
Sponsored by NCIC Clinical Trials Group · Phase 2, Interventional, and Treatment
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.
365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's enrollment of 27 is below the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →NCIC Clinical Trials Group is the lead sponsor of 114 studies on the registry; none are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 7 (26%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis
Must have 1 or more of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 2 prior chemotherapy regimens
Endocrine therapy
Radiotherapy
Surgery
Other
PS-341 bolus intravenous injection twice weekly\* for 2 out of every 3 weeks
Response rate
To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia
Time frame: 4 years
Toxicity
To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.
Time frame: 4 years
Cytogenetics and genome profiling
To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
Time frame: 4 years
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Waldenstrom Macroglobulinemia→
NCIC Clinical Trials Group