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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01349569
Eligibility Criteria:
Inclusion Criteria:
* Myeloma eligibility criteria are the following:
* sustained near complete remission (nCR) for 4 months defined as no measurable M-spike and a positive immunofixation
* early biochemical relapse as manifest by going from a true CR (immunofixation negative) to a nCR (immunofixation positive) at any time
* conversion from a nCR to the appearance of a monoclonal spike in the serum not greater than 0.3mg/dL
* age 18 years and older
* Eastern Cooperative Oncology Group performance scores 0-2
* History of measurable serum or urine M protein or free light chains
* Life expectancy greater than 12 months
* Corrected serum calcium \< 11 mg/dL, and no evidence of symptomatic hypercalcemia
* Serum creatinine\< 2
* Absolute Neutrophil Count \>1000
* Platelet \>100,000
* Total bilirubin less than or equal to 1.5 x Upper limit of normal
* Aspartate aminotransferase and Alanine transaminase less than or equal to 3 x Upper limit of normal
* Negative pregnancy test if applicable
* Ability to comprehend and have signed the informed consent.
* Disease free of prior malignancies for \< 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
* All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
* Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
* Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin).
Exclusion Criteria:
* Disease progression after stopping corticosteroids as defined as the appearance of an M-spike \>0.5g/dL
* Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, non-secretory myeloma and amyloidosis.
* HIV disease, active infection requiring treatment with antibiotics, anti-fungal or anti-viral agents within 2 weeks of enrollment would be excluded from the study.
* Patients who have participated in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug.
* History of an active malignancy other than myeloma
* Autoimmune disease requiring active treatment.
* Known contra-indication to any component of Prevnar 13 including the diphtheria toxoid-containing vaccine.
* History of latex allergy
* History of an autologous stem cell transplant within the past 12 months or less
* History of an allogeneic transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01349569
Study Brief:
Protocol Section:
NCT01349569