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:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT00441168
Eligibility Criteria:
Inclusion Criteria:
* Relapsed or refractory multiple myeloma following 1 previous line of therapy and, is scheduled by the investigator to be treated with vincristine, adriamycin and dexamethasone standard therapy
* measurable secretory multiple myeloma based on defined criteria
* Karnofsky performance status of \>or = 60%
* fulfils defined laboratory requirements within 14 days before baseline
* if female, the patient is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control for defined period of time
* if male, the patient agrees to use an acceptable barrier method for contraception for a defined period of time.
Exclusion Criteria:
* More than one previous line of therapy for multiple myeloma
* use of bortezomib in the previous line of therapy and/or received bortezomib in a previous trial
* known allergy or hypersensitivity to bortezomib, boron or mannitol
* peripheral neuropathy or neuropathic pain of grade 2 or higher
* myocardial infarction within 6 months of enrollment or had New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00441168
Study Brief:
Protocol Section:
NCT00441168