Clinical trial NCT01206205 (phase 2, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: lenalidomide, bortezomib
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with multiple myeloma based on standard diagnostic criteria or by
             the new International Myeloma Foundation 2003 Diagnostic Criteria

          -  Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related
             organ damage

          -  Subjects must have measurable disease requiring systemic therapy.

          -  Male or female subject 18 years of age or older

          -  Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group
             Performance Status score ≤2)

          -  Voluntary written informed consent must be given before performance of any
             study-related procedure not part of normal medical care, with the understanding that
             consent may be withdrawn by the subject at any time without prejudice to future
             medical care.

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 3 days prior to therapy. They must commit to continued abstinence from
             heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly
             effective method and 1 additional effective method) used at the same time, beginning
             at least 4 weeks before initiation of Revlimid treatment. Women must also agree to
             ongoing pregnancy testing

          -  Men must agree to not father a child and agree to use a latex condom during therapy
             and for 4 weeks after the last dose of study drug, even if they have had a successful
             vasectomy, if their partner is of childbearing potential.

        Exclusion Criteria:

          -  Subjects must not have been treated previously with any systemic therapy for multiple
             myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify
             the subject (the maximum dose of corticosteroids should not exceed the equivalent of
             160 mg of dexamethasone in a 2-week period). Two weeks must have elapsed since the
             date of the last radiotherapy treatment. Enrollment of subjects who require concurrent
             radiotherapy (which must be localized in its field size) should be deferred until the
             radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.

          -  AL amylo

          -  ≥Grade 2 peripheral neuropathy on clinical examination within 14 days before
             enrollment

          -  Renal insufficiency (serum creatinine >2.5 mg/dL)

          -  Evidence of mucosal or internal bleeding and/or platelet refractory

          -  Platelet count <70,000 per µL

          -  ANC < 1000 cells/mm3

          -  AST or ALT greater than or equal to 2 x ULN

          -  Total bilirubin >3 × ULN

          -  Myocardial infarction within 6 months prior to enrollment according to NYHY Class III
             or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias,
             or electrocardiographic evidence of acute ischemia or active conduction system
             abnormalities

          -  Clinically relevant active infection or serious co-morbid medical conditions

          -  Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in
             situ cervical, breast or prostate cancer

          -  Female subject who is pregnant or breast-feeding

          -  Serious medical or psychiatric illness likely to interfere with participation in study

          -  Uncontrolled diabetes mellitus

          -  Known HIV infection

          -  Known active hepatitis B or C viral infection

          -  Known intolerance to steroid therapy

          -  History of allergy to any of the study medications, their analogues, or excipients in
             the various formulations