- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02082405
Bortezomib, Dexamethasone, and Cyclophosphamide in Treating Older Patients With Multiple Myeloma
A Phase II Trial of Weekly Bortezomib and Dexamethasone With Oral Metronomic Cyclophosphamide in Elderly Patients With Plasma Cell Myeloma
Study Overview
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (bortezomib, cyclophosphamide, dexamethasone)
Patients receive bortezomib SC or IV over 3-5 seconds on days 1, 8, and 15; cyclophosphamide PO 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.
|
Ancillary studies
Other Names:
Given PO
Other Names:
Optional correlative studies
Given PO
Other Names:
Given SC or IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response rate in accordance with the IMWG Uniform Response criteria
Time Frame: Up to 7 months
|
The number of people with any response as defined by the IMWG criteria
|
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
|
Up to 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
Time Frame: Up to 24 weeks
|
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.
|
Up to 24 weeks
|
Changes in functional status
Time Frame: Up to 24 weeks
|
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).
|
Up to 24 weeks
|
Overall Survival
Time Frame: 24 Weeks
|
The number of people alive after 24 weeks on the study
|
24 Weeks
|
Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
Time Frame: After 6 weeks (2 courses) of treatment
|
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.
|
After 6 weeks (2 courses) of treatment
|
Changes in functional status
Time Frame: After 6 weeks (2 courses) of treatment
|
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).
|
After 6 weeks (2 courses) of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erica Campagnaro, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dexamethasone
- Cyclophosphamide
- Bortezomib
Other Study ID Numbers
- CASE3A13
- P30CA043703 (U.S. NIH Grant/Contract)
- NCI-2014-00250 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CASE 3A13 (Other Identifier: Case Comprehensive Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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