Status:
WITHDRAWN
S0629, Observation or Combination Chemotherapy, Bortezomib, Thalidomide, and Rituximab Followed By Two Autologous Peripheral Blood Stem Cell Transplants in Treating Patients With Waldenstrom Macroglobulinemia
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. Giving combination chemotherapy together with bortezomib, thalidomide, and ritu...
Detailed Description
OBJECTIVES: Primary * To assess the progression-free and overall survival of patients with symptomatic Waldenstrom macroglobulinemia treated with bortezomib, dexamethasone, thalidomide, cisplatin, d...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00723658
Start Date
September 1 2008
Last Update
March 6 2015
Active Locations (29)
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1
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
2
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
3
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
4
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044