Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis
| Status: | Archived |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2010 |
Phase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain Amyloidosis
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and
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 combination
chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and
dexamethasone together works in treating patients with primary systemic light chain
amyloidosis.
PRIMARY OBJECTIVE:
I. To assess the confirmed hematologic response rate (ACR + VGPR + PR) of the combination of
bortezomib, cyclophosphamide and dexamethasone in patients with primary systemic
amyloidosis.
SECONDARY OBJECTIVES:
I. Organ response rate of the bortezomib, cyclophosphamide and dexamethasone combination.
II. Severity and frequency of adverse events associated with bortezomib, cyclophosphamide
and dexamethasone treatment in patients with primary systemic amyloidosis.
III. Time to progression.
IV. Survival.
OUTLINE: Patients receive bortezomib IV on days 1, 8, and 15 and oral cyclophosphamide and
oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for
up to 12 courses in the absence of disease progression or unacceptable toxicity. After
completion of study treatment, patients are followed every 6 months for 2 years.
We found this trial at
2
sites
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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