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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT00555906
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of symptomatic multiple myeloma as defined by International Myeloma Working Group (IMWGURC).
* Phase 1: Relapsed or relapsed/refractory myeloma after at least 1 previous treatments and with a life expectancy of more than 3 months.
* Phase 2: Measurable (as defined by IMWGURC) disease after at least 1 previous treatment.
Exclusion Criteria:
* History of allogeneic stem cell transplant.
* Phase 2 only: Prior bortezomib therapy will only be allowed if there was a demonstrated positive response, and disease progression occurred off therapy.
* Must have not experienced significant blood level changes, e.g. very low platelets, while on previous bortezomib therapy
* Prior radiation therapy to \> 25% of the bone marrow (whole pelvis is 25%).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00555906
Study Brief:
Protocol Section:
NCT00555906