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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT00315757
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with multiple myeloma that is refractory or has relapsed after treatment
* Measurable serum and/or urine M-protein
* Failed 1 or 2 prior therapies for multiple myeloma
* 18 years of age or older
Exclusion Criteria:
* Received more than 2 prior therapies for multiple myeloma.
* Previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks
* Received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)
* Received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks
* Subjects who received a stem cell transplant using cells from themselves in the past 16 weeks
* Subjects who received a stem cell transplant using cells from another individual
* Previously treated with bortezomib or mapatumumab
* Known HIV, hepatitis-B, hepatitis-C, or hepatitis A infection
* Infection requiring antibiotics or hospitalization within the last 2 weeks
* Major surgery within the last 4 weeks
* Diagnosis with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
* History of other cancers within the past 5 years
* Pregnant or breast-feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00315757
Study Brief:
Protocol Section:
NCT00315757