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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WITHDRAWN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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (29 locations)

    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