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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT02416206
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 - 70 years
* Karnofsky status ≥ 70%
* Diagnosis of Multiple Myeloma
* Within 9 months of the start of induction chemotherapy and no evidence of relapse or progression.
* Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least 2x106/kg.
Exclusion Criteria:
* Poor cardiac function: left ventricular ejection fraction \<40%
* Poor pulmonary function: FEV1, FVC, or DLCO \<40% predicted
* Poor liver function: bilirubin \>2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT \> 3X ULN
* Poor renal function: Creatinine \>2.0 mg/dl or creatinine clearance \< 40 mL/min (calculated creatinine clearance is permitted)
* Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
* Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
* Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02416206
Study Brief:
Protocol Section:
NCT02416206