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:
NCT00165295
Eligibility Criteria:
Inclusion Criteria:
* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
* Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of \> 2 times the upper limit of each institution's normal value
* Slowly progressing disease not requiring therapy for at least 3-6 months
* ECOG performance status 0,1 or 2
* Total bilirubin \< 2 x ULN
* SGOT \< 3 x ULN
* Creatinine \< 2 x ULN
Exclusion Criteria:
* Pregnant or breast-feeding women
* Patients who are using organic nitrates or alpha-blockers
* Grade III/IV cardiac problems
* Resting hypotension (BP \< 90/50) or hypertension (BP \> 170/110)
* Cardiac failure or coronary artery disease causing unstable angina
* Evidence of left ventricular outflow obstruction
* Impaired autonomic control of blood pressure
* Sickle cell anemia
* History of priapism
* Severe and/or uncontrolled medical disease
* Known chronic liver disease
* Currently using ritonavir
* History of retinal pigmentosa
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00165295
Study Brief:
Protocol Section:
NCT00165295