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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT01838369
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria:
* Serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10 percent.
* Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder.
* Male or female, 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
Exclusion Criteria:
* Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma.
* Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator.
* Severe other conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01838369
Study Brief:
Protocol Section:
NCT01838369