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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Overall Response rate in accordance with the IMWG Uniform Response criteria
The number of people with any response as defined by the IMWG criteria
Time frame: Up to 7 months
Incidence of toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4
Time frame: Up to 7 months
Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
Changes in quality of life at baseline to the end of treatment estimated by means with confidence intervals. Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.
Time frame: Up to 24 weeks
Changes in functional status
Changes in functional status at baseline to the end of treatment estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).
Time frame: Up to 24 weeks
Overall Survival
The number of people alive after 24 weeks on the study
Time frame: 24 Weeks
Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
Average changes in quality of life at baseline estimated by means with confidence intervals.Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.
Time frame: After 6 weeks (2 courses) of treatment
Changes in functional status
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Optional correlative studies
Ancillary studies
Changes in functional status at baseline to the second course 2 of therapy estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).
Time frame: After 6 weeks (2 courses) of treatment