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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01670994
Eligibility Criteria:
ENTRY CRITERIA:
DISEASE CHARATERISTICS:
* Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens.
* Refractory disease is defined as progressive disease while on therapy or progression within 60 days of therapy.
* Progressive disease is defined by a 25% increase from the lowest response value in specified tests.
* Measurable disease as defined by at least one of the following:
* Serum M-protein ≥ 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA)
* Urine M-protein ≥ 200mg/24hours
* Serum free light chains ≥ 10 mg/dL and abnormal kappa/lambda ratio
PRIOR/CONCURRENT THERAPY:
* No anti-myeloma treatments within 28 days before the start of study treatment.
* Must have recovered from side effects of prior treatments.
PATIENT CHARACTERISTICS:
Age
• ≥ 18 years
Performance Status
• ECOG 0, 1, or 2
Bone Marrow Reserve
* Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL
* Platelets ≥ 30,000/uL
* Hemoglobin ≥ 8g/dL
Renal Function
• Glomerular Filtration Rate (GFR) \> 45mL/min/1.73m\^2
Hepatic Function
* Total bilirubin ≤ 2.0 X ULN
* AST, ALT, ALP ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver metastases exist)
Cardiovascular
* No congestive heart failure \< 6 months
* No unstable angina pectoris \< 6 months
* No myocardial infarction \< 6 months
* No history of ventricular arrhythmias
* No history of supraventricular arrhythmias
* No NYHA Class \> II CHF
* Normal Transthoracic Echocardiogram (TTE) is required for patients with history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or with a history of having received adriamycin or doxorubicin
* Patients with a left ventricular ejection fraction (LVEF) of less than 50% will be excluded from study entry
Pulmonary
• Normal clinical assessment of pulmonary function
Other
* Negative serum pregnancy test if female and of childbearing potential
* Women who are not pregnant or nursing
* Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
* No known autoimmune disease other than corrected hypothyroidism
* No known prior organ allograft or allogeneic transplantation
* Not HIV positive
* No history or evidence of uncontrollable CNS disease
* No psychiatric illness/social situation
* No other illness that in the opinion of the investigator would exclude the subject from participating in the study
* Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
* Active systemic infection requiring parenteral antibiotic therapy.
* No ongoing chronic systemic steroid therapy required.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01670994
Study Brief:
Protocol Section:
NCT01670994