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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01495351
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of multiple myeloma.
* Measurable disease, according to the International Myeloma Working Group criteria.
* ECOG performance status 0, 1 or 2.
* Patients must have received prior treatment for MM and have relapsed or progressed on prior therapy; no limit on number of prior treatment regimens, but prior treatment must be completed 2 weeks prior to registration. Prior exposure to Bortezomib is not an exclusion criteria as long as patients did not progress or relapse while receiving or within 3 months of completing trt with bortezomib
* Prior radiation, completed at least 4 weeks prior to registration, is permitted.
* Adequate marrow reserve, liver and renal function
Exclusion Criteria:
* patients with a history of other malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, prostate cancer with stable PSA for \> 3 years, or other solid tumours curatively treated with no evidence of disease for \> 5 years.
* Patients with preexisting grade 2 (or higher) sensory neuropathy or grade 1 sensory neuropathy with neuropathic pain.
* Pregnant or lactating women
* Patients receiving concurrent treatment with other anti-cancer therapy any other investigational agents.
* Active or uncontrolled infections
* Patient with known documented congenital or acquired risk factor for thromboembolic event
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01495351
Study Brief:
Protocol Section:
NCT01495351