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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00153920
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of multiple myeloma based upon standard criteria
* Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \> 1 g/dl and/or urine monoclonal immunoglobulin spike of \> 200mg/24 hours.
* Karnofsky performance status of \> 60
* Hemoglobin \> 8.0 g/dL
* AST (SGOT) \< 3 x ULN
* ALT \< 3 x ULN
* Total bilirubin \< 2 x ULN
* Is infertile or is practicing an adequate form of contraception
* 18 years of age or older
Exclusion Criteria:
* Prior treatment with systemic chemotherapy
* Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes
* Plasma cell leukemia
* Calculated or measured creatinine clearance \< 30 mL/minute within 14 days of enrollment
* Grade 2 or greater peripheral neuropathy
* Hypersensitivity to bortezomib, boron or mannitol
* Severe hypercalcemia
* HIV positive
* Known active hepatitis B or C
* New York Hospital Association Class III or IV heart failure
* Second malignancy requiring concurrent treatment
* Other serious medical or psychiatric illness
* Pregnant women
* Dialysis dependent patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00153920
Study Brief:
Protocol Section:
NCT00153920