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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT02492750
Eligibility Criteria:
Inclusion Criteria:
* Absolute neutrophil count (ANC) \>= 1700/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8.0 g/dL
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3 x upper limit of normal (ULN)
* Creatinine clearance \>= 30 mL/min (as determined by Cockroft-Gault equation)
* Diagnosis of multiple myeloma according to International Myeloma Working Group criteria and one of the following:
* Smoldering multiple myeloma (SMM)
* Indolent multiple myeloma (IMM)
* Newly diagnosed multiple myeloma (MM)
* Note: patients with lytic disease and anemia are eligible
* High risk disease defined by all of the following:
* \>= 10% bone marrow plasma cells AND
* Abnormal serum free light chain (FLC) ratio (\< 0.26 or \> 1.65) by serum FLC assay AND
* Monotypic plasma cell S-phase \>= 0.3%
* Measurable level of M-protein \> 1 g/dL on serum protein electrophoresis or \> 200 mg of M-protein on a 24 hour urine protein electrophoresis
* Negative tuberculosis (TB) testing (Quantiferon - TB blood test or skin test) =\< 7 days prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Provide signed informed consent
* Negative (serum or urine) pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only; NOTE: a second pregnancy test must be performed within 24 hours prior to the start of lenalidomide; the subject may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Willing and able to comply with the requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
* Females of childbearing potential must be willing to adhere to the scheduled pregnancy testing as required by the Revlimid REMS program
Exclusion Criteria:
* Prior treatment with any other agent that may affect M-protein =\< 30 days prior to registration
* Acute/chronic infections, open wounds, or any active infection requiring intravenous antibiotic therapy =\< 12 weeks prior to registration
* Other active malignancy (=\< 3 years) prior to registration; exceptions: basal cell skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* New York Heart Association (NYHA) class 3 or 4 congestive heart failure (CHF) symptoms
* Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are allowed while on protocol treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02492750
Study Brief:
Protocol Section:
NCT02492750