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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT02401295
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of relapsed multiple myeloma
* Recent salvage transplant (≤ 6 months but ≥ 45 days post-transplant prior to study enrollment) for relapse
* 18-75 years of age at the time of study entry
* Platelet count ≥70K/mm3 un-transfused
* Resolution of all transplant-related toxicity to ≤ grade 2 per CTCAE v.4
* Left ventricular ejection fraction as measured by ECHO or MUGA should be ≥ 40%
* Creatinine of ≤ 2 mg/dl and a calculated GFR of \>50mL/min/1.73m2
* A total bilirubin, ALT, AST, and alkaline phosphatase of ≤ 2 ULN
* Performance status of 0-2 based on the ECOG criteria. Patients with performance status 3 or 4, based solely on bone pain, are also eligible, provided that there is a source document to verify this
* Prospective study participants must be informed of the investigational nature of the study and must have signed an IRB-approved informed consent form in accordance with institutional and federal guidelines
Exclusion Criteria:
* Prior allogeneic transplant
* Greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening
* Uncontrolled diabetes
* Recent (\< 6 months) myocardial infarction, unstable angina, CABG or stent placement in the last 2 years, difficult-to-control congestive heart failure, uncontrolled hypertension (systolic blood pressure \> 160 mm or a diastolic BP \> 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult- to-control cardiac arrhythmias
* Evidence of QT prolongation and/or torsades de pointes (TdP) on EKG.
* Any co-morbid condition that poses a greater threat to the patient's life expectancy than the recurrent myeloma
* No concurrent malignancy with a life expectancy of less than two years, or one that requires ongoing chemotherapeutic intervention at screening
* Presence of an infection that requires intravenous antibiotics
* Pregnant or nursing females. Any patient of reproductive potential may not participate unless he/she has agreed to use an effective contraceptive method as covered during the informed consent process
* Known history of an HIV seropositive test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02401295
Study Brief:
Protocol Section:
NCT02401295