Stage III Multiple Myeloma Clinical Trial
Official title:
A Phase II Trial of Weekly Bortezomib and Dexamethasone With Oral Metronomic Cyclophosphamide in Elderly Patients With Plasma Cell Myeloma
This phase II trial studies the side effects and how well lower doses of bortezomib, dexamethasone, and cyclophosphamide work in treating older patients with multiple myeloma. 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 cyclophosphamide daily may kill more cancer cells. Giving bortezomib, cyclophosphamide, and dexamethasone may be an effective treatment for multiple myeloma.
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR) and toxicity rate of therapy with weekly
bortezomib combined with oral metronomic cyclophosphamide and low-dose dexamethasone.
SECONDARY OBJECTIVES:
I. To determine overall survival. II. To describe the association between disease status,
treatment response, treatment toxicity, quality of life, functional status, risk for
development of frailty, and inflammatory cytokine levels.
OUTLINE:
Patients receive bortezomib subcutaneously (SC) or intravenously (IV) over 3-5 seconds on
days 1, 8, and 15; cyclophosphamide orally (PO) once daily (QD) on days 1-21; and
dexamethasone PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 8 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 3
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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