Clinical trial NCT01042704 (phase 1, status: completed)
Conditions: myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: bendamustine, lenalidomide, dexamethasone, aspirin, prophylaxis, antibiotic
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, 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, CC(=O)OC1=CC=CC=C1C(O)=O, [H][C@]12SC(C)(C)[C@@H](N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=CC=C1)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed symptomatic Multiple
             Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that
             has been previously treated with at least one cycle of a specific therapy; after which
             the patient has shown progressive or refractory disease, and must meet at least one of
             the following parameters of measurable disease:

          -  Bone marrow plasmacytosis with > 10% plasma cells, or sheets of plasma cells, or
             biopsy proven plasmacytoma which must be obtained within 6 weeks prior to
             registration.

          -  Measurable levels of monoclonal protein (M protein): > 1 g/dL of IgG or IgM M-protein
             or > 0.5 g/dL IgA or IgD M protein on serum protein electrophoresis OR > 200 mg of
             free light chain on a 24 hour urine protein electrophoresis which must be obtained
             within 4 weeks prior to registration OR > 20 mg/dL involved free light chain on serum
             free light chain testing with an abnormal kappa:lambda light chain ratio. Note that if
             both serum and urine m-components are present, both must be followed in order to
             evaluate response. Both SPEP and UPEP must be performed within 28 days prior to
             registration.

          -  Patients with lytic bone disease, defined as at least one lytic lesion that can be
             accurately measured in at least one dimension.

          -  Patients must have received prior chemotherapy for their myeloma, but not in the last
             4 weeks. Patients may have previously received autologous peripheral blood stem cell
             transplantation. Prior treatment with lenalidomide is allowed.

          -  Patients should not have received any radiation for the preceding 4 weeks before entry
             onto the study. Exception: local radiation therapy for symptomatic bone lesions
             (eg,uncontrolled pain or high risk of pathologic fracture)

          -  Age >= 18 years

          -  Life expectancy of greater than 6 months.

          -  ECOG performance status >=2 (Karnofsky >=60%). Patients with PS of 3 are eligible if
             their PS is due to pain, which would likely improve with treatment.

          -  Patients must have normal organ and marrow function as defined below, obtained within
             4 weeks prior to registration:

               -  Hgb > 9 g/dL (which may be supported by transfusion or growth factors)

               -  leukocytes >=2,000/ml

               -  absolute neutrophil count ≥1000/ ml

               -  platelets >=75,000/mcL

               -  total bilirubin >=2.5 mg/dl

               -  AST(SGOT)/ALT(SGPT) >=5 X institutional upper limit of normal

               -  creatinine <2.5 mg/dl

          -  Patients must not be pregnant or breast feeding. Due to the potential teratogenic
             properties of lenalidomide, the use of this drug in patients that are pregnant is
             absolutely contraindicated. Further, all women of childbearing potential and sexually
             active males must agree to avoid conception while participating in this study.
             Specifically, women of childbearing potential must either agree to refrain from sexual
             intercourse or employ a dual method of contraception, one of which is highly effective
             (IUD, birth control pills, tubal ligation or partners vasectomy), and another
             additional method (condom, diaphragm, or cervical cap) for 4 weeks prior to receiving
             lenalidomide, and for four weeks after discontinuing this therapy. Sexually active
             males cannot participate unless they agree to use a condom (even if they have
             undergone a prior vasectomy) while having intercourse with a woman of child bearing
             potential while taking lenalidomide and for four weeks after stopping treatment. Women
             of child bearing potential (those who have not had a hysterectomy or the absence of
             menstrual periods for at least 24 consecutive months) must have a negative pregnancy
             test 10-14 days prior to the initiation of therapy and a repeat negative pregnancy
             test 24 hours prior to the initiation of lenalidomide.

          -  Ability to understand and the willingness to sign a written informed consent document.
             Patient must be informed of the investigational nature of this study.

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
             the study or those who have not recovered from adverse events due to agents
             administered more than 4 weeks earlier. Exception: local radiation therapy for
             symptomatic bone lesions (eg, uncontrolled pain or high risk of pathologic fracture)

          -  Patients receiving any other investigational agents.

          -  Patients with known brain metastases will be excluded from this clinical trial because
             of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  Patients with a history of allergic reactions attributed to compounds of similar
             chemical or biologic composition to lenalidomide and/or Bendamustine or other agents
             used in the study.

          -  Patients with a second malignancy other than squamous/basal cell carcinoma of the skin
             or in situ carcinoma of the cervix unless the tumor was curatively treated at least
             two years previously.

          -  Inability to comply with study and/or follow-up procedures.

          -  If a patient is on full-dose anticoagulants, the following criteria should be met for
             enrollment:

               -  Must not have active bleeding or pathological conditions that carry high risk of
                  bleeding (e.g. tumor involving major vessels, known varices).

               -  Must have a platelet count >75,000.

               -  Must have stable INR between 2-3.

          -  Patients who have not collected hematopoietic progenitors and are potential candidates
             for autologous transplantation .

          -  Patients that have a serious cardiac condition, such as myocardial infarction within 6
             months or heart disease as defined by the New York Heart Association Class III or IV,

          -  Patients with prior allogeneic stem cell transplant.

          -  Non-secretory patients (i.e., patients who do not meet the minimum M-protein or light
             chain criteria)