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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00723658
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of Waldenstrom macroglobulinemia (WM)
* Measurable disease as determined by IgM protein quantification
* Must be registered to the treatment portion of the study within 28 days of experiencing disease-related symptoms\* AND must present with ≥ 1 of the following disease-related symptoms:
* Hemoglobin ≤ 11 g/dL
* Platelet count ≤ 100,000/mm³
* Marked tumor mass, defined as lymphadenopathy \> 2 cm, palpable hepatomegaly, splenomegaly, or significant marrow involvement (\> 50%)
* Serum albumin \< 2.5 g/dL
* Persistently elevated beta-2-microglobulin \> 3.0 mg/L in the absence of renal impairment or active infections
* Presence of B symptoms (i.e., fever, night sweats, or weight loss of \> 10% from baseline)
* Appearance of new or worsening neuropathy manifested by numbness and tingling or pain
* Symptomatic cryoglobulinemia (i.e., Raynaud phenomenon, skin ulcers, cold urticaria, or skin necrosis)
* Symptoms of hyperviscosity, if measured viscosity \> 4 cp (i.e., new headaches, vertigo, ataxia, dizziness with or without evident causes of changes in funduscopic exam, including retinal vein engorgement, hemorrhages, or exudates)
* NOTE: \*Appearance of any of the above symptoms caused by WM with no other obvious cause is a trigger for treatment initiation. Symptoms need not persist for any specified time frame.
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2 (Zubrod performance status 3 allowed provided it is based solely on morbidity due to WM)
* ANC \> 1,500/mm³ (unless more marked cytopenias can be explained by marked marrow involvement or autoimmune myelosuppression)
* Serum creatinine \< 3 mg/dL
* Creatinine clearance \> 30 mL/min
* SGOT/SGPT \< 2 times upper limit of normal
* Direct bilirubin \< 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception according to the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®) program
* Ejection fraction ≥ 50% by ECHO or MUGA scan
* Patients with evidence of amyloidosis (i.e., periorbital perforation, proteinuria not attributable to Bence-Jones protein, unexplained arrhythmias, increased liver function tests, peripheral neuropathy, carpal tunnel syndrome, and/or macroglossia) must have an ECHO, rather than MUGA, performed to evaluate for cardiac amyloidosis (septal thickness, diastolic dysfunction, granular sparkling, or low-voltage QRS complexes)
* No myocardial infarction within the past 6 months
* No unstable angina
* No difficult-to-control congestive heart failure or cardiac arrhythmias
* No uncontrolled hypertension
* No peripheral neuropathy ≥ grade 2
* No history of multi-infarced dementia or multiple strokes
* No known hypersensitivity to boron or mannitol
* No hepatitis B or C positivity
* No HIV positivity
* No other prior malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
* At least 28 days since prior chemotherapy and/or radiotherapy and recovered
* No prior bortezomib
* No concurrent glucocorticoids unless used to control autoimmune disease associated with WM
* Concurrent participation in the Myeloma Specimen Repository study allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00723658
Study Brief:
Protocol Section:
NCT00723658