Clinical trial NCT00553644 (phase 2, status: completed)
Conditions: recurrent mantle cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib, lenalidomide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented mantle cell lymphoma, with the following immunophenotypic
             characteristics: cluster of differentiation (CD)5+, CD23-, cyclin D1+; this may be
             from an initial diagnostic biopsy, or one obtained at time of relapse

               -  Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they
                  may be submitted in conjunction with nodal biopsies; fine needle aspirates are
                  not acceptable

               -  Failure to submit pathology specimens within 60 days of patient registration will
                  be considered a major protocol violation

          -  Institutional flow cytometry or immunohistochemistry must confirm CD5 antigen
             expression, lack of CD23 antigen expression, and expression of cyclin D1

          -  Prior therapy with at least one regimen, which may have been single agent or
             multi-agent, and consisted of traditional cytotoxic agents and/or biologic agents;
             patient may not have received prior bortezomib or lenalidomide therapy; patient must
             have progressive disease or refractory disease following that initial regimen(s);
             refractory disease will be defined as stable disease (SD) or progressive disease (PD)
             as best response to prior therapy, or CR or PR as initial response followed by disease
             progression within 6 months

          -  Prior autologous, but not allogeneic, stem cell transplant is allowed

          -  No corticosteroids within two weeks prior to study, except for maintenance therapy for
             a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone
             or equivalent

          -  No prior radioimmunotherapy within 12 months of study entry

          -  No >= grade 3 peripheral neuropathy within a month prior to study entry

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Measurable disease must be present either on physical examination or imaging studies;
             non-measurable disease alone is not acceptable; any tumor mass > 1 cm by physical
             exam, computed tomography (CT), magnetic resonance imaging (MRI), or conventional
             radiograph is acceptable; lesions that are considered non-measurable include the
             following:

               -  Bone lesions (lesions, if present, should be noted)

               -  Ascites

               -  Pleural/pericardial effusion

               -  Lymphangitis cutis or pulmonis

               -  Bone marrow (involvement by non-Hodgkin lymphoma should be noted)

          -  No known central nervous system (CNS) involvement by lymphoma

          -  Patients with human immunodeficiency virus (HIV) infection are eligible, provided they
             meet the following: CD4+ cell count > 350/mm^3; treatment sensitive HIV and, if on
             anti-HIV therapy, HIV viral load < 50 copies/mm^3; no history of acquired
             immunodeficiency syndrome (AIDS)-defining conditions or other HIV-related illnesses;
             no concurrent zidovudine or stavudine

          -  Non-pregnant and non-nursing; females of childbearing potential (FCBP) must have a
             negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within
             10-14 days prior to registration; further, they must either commit to continued
             abstinence from heterosexual intercourse or begin TWO acceptable methods of birth
             control: one highly effective method and one additional effective method AT THE SAME
             TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing
             pregnancy testing; men must agree to use a latex condom during sexual contact with a
             FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman
             who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
             naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at
             any time in the preceding 24 consecutive months); all patients must be counseled by a
             trained counselor every 28 days about pregnancy precautions and risks of fetal
             exposure; documentation of counseling is required on Cancer and Leukemia Group B
             (CALGB) form S-041

          -  Patients with a recent history (within 3 months of study entry) of deep vein
             thrombosis (DVT)/pulmonary embolism (PE) are not eligible; patients with a distant
             history (greater than 3 months before study entry) of DVT/PE are eligible, but must
             receive either prophylactic aspirin or low molecular weight heparin, unless
             contraindicated

          -  Left ventricular ejection fraction (LVEF) >= 45% by multigated acquisition (MUGA) scan
             or echocardiogram

          -  No New York Heart Association class III or class IV congestive heart failure at study
             entry

          -  No myocardial infarction within the past 6 months of study entry

          -  No known positivity for hepatitis A, B, or C

          -  Absolute neutrophil count (ANC) >= 1,000/uL (>= 500/uL if marrow involvement)

          -  Platelets >= 75,000/uL

          -  Creatinine =< 1.5 x upper limit of normal (ULN) (unless attributable to non-Hodgkin's
             lymphoma) and estimated creatinine clearance >= 30 mL/min (patients on dialysis are
             not eligible)

          -  Total bilirubin =< 2 x ULN (unless attributable to non-Hodgkin's lymphoma and
             Gilbert's disease)

          -  Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative