Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT02082405
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02082405
Study Brief:
Protocol Section:
NCT02082405