Bortezomib, Dexamethasone, and Cyclophosphamide in Treating Older Patients With Multiple Myeloma
Information source: Case Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
Intervention: bortezomib (Drug); cyclophosphamide (Drug); dexamethasone (Drug); laboratory biomarker analysis (Other); quality-of-life assessment (Other)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Case Comprehensive Cancer Center Official(s) and/or principal investigator(s): Erica Campagnaro, Principal Investigator, Affiliation: Case Comprehensive Cancer Center
Summary
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.
Clinical Details
Official title: A Phase II Trial of Weekly Bortezomib and Dexamethasone With Oral Metronomic Cyclophosphamide in Elderly Patients With Plasma Cell Myeloma
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Response rate in accordance with the IMWG Uniform Response criteriaIncidence of toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4
Secondary outcome: Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-GeneralChanges in functional status Overall Survival Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General Changes in functional status
Detailed description:
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must have a confirmed diagnosis of symptomatic myeloma in accordance with
International Myeloma Working group (IMWG) criteria
- Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or
biopsy proven plasmacytoma
- Symptomatic disease, i. e., end-organ damage due to multiple myeloma (MM)
including at least one of the following: anemia, hypercalcemia, bone disease
(lytic bone lesions or pathologic fracture), or renal dysfunction
- Absolute neutrophil count (ANC) >= 1000 cells/mm^3 (without use of growth factors)
- Platelets >= 50,000 cells/mm^3
- Direct bilirubin =< 1. 5 X upper limit of normal (ULN); elevated bilirubin is
permissible if patient has a known history of elevated bilirubin due to Gilbert's or
if elevated bilirubin is due to hemolysis
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1. 5
X ULN
- Subjects must have the ability to understand and the willingness to sign a written
informed consent document
Exclusion Criteria:
- Prior treatment with > 1 cycle of any plasma cell myeloma (PCM) induction regimen
(maximum 6 weeks of prior treatment)
- Prior radiation therapy is allowed
- Prior treatment for other cancers is allowed as long as patient meets criteria
for adequate hematopoietic and organ function and is not actively on
chemotherapy for another cancer
- Grade >= 2 peripheral neuropathy
- Second malignancy currently undergoing chemotherapy or radiotherapy; hormonal therapy
for breast or prostate cancer is allowed
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to bortezomib, cyclophosphamide, dexamethasone or other agents used in
this study
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements
Locations and Contacts
Additional Information
Starting date: April 2015
Last updated: April 23, 2015
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