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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT01553357
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL
* Age \> 18 years
* ECOG performance status of 0,1 or 2
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Myocardial infarction within 6 months prior to enrollment or uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* ECG evidence of acute ischemia or active conduction system abnormalities
* Female subjects either pregnant or breast-feeding
* Serious medical or psychiatric illness
* Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy)
* History of severe hepatic dysfunction
* Active infections or HIV positivity
* Uncontrolled insulin-dependent diabetes mellitus
* Uncompensated major thyroid or adrenal dysfunction
* Hemodialysis or peritoneal dialysis
* Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
* ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01553357
Study Brief:
Protocol Section:
NCT01553357