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 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT00911859
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for high dose chemotherapy with stem cell transplantation
* Eastern cooperative oncology group performance status score of less than or equal to 2
* Measurable secretory disease, defined as either serum monoclonal paraprotein greater than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours
* Adequate laboratory results that will be confirmed by a study physician
* Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
* Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance
* Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
* Received prior or current systemic therapy or stem cell transplantation for multiple myeloma
* Peripheral neuropathy or neuropathic pain (Grade 2 or higher)
* Received radiation therapy, plasmapheresis or surgery within 14 days
* Transplanted solid organ, with the exception of a corneal transplant
* Serious concurrent illness or history of uncontrolled heart disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00911859
Study Brief:
Protocol Section:
NCT00911859