Clinical trial NCT00723658 (phase 2, status: withdrawn)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib, carmustine, cisplatin, cyclophosphamide, cytarabine, dexamethasone, doxorubicin hydrochloride, etoposide, melphalan, thalidomide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCNC(=O)N(CCCl)N=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Reason stopped: 
    lack of accrual
  
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