Clinical trial NCT00729638 (phase 1, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: rad001, lenalidomide
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](O)[C@@H](C1)OC, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject was previously diagnosed with multiple myeloma bases on standard criteria
             listed in protocol

          -  Patients must have relapsed or relapsed/refractory disease

          -  18 years of age or older

          -  All necessary baseline studies for determining eligibility must be obtained within 21
             days prior to enrollment

          -  ECOG Performance Status of 0 to 2

          -  Able to take aspirin (81 or 325mg) daily as prophylactic anticoagulation

          -  Prior thalidomide/lenalidomide therapy is allowed

          -  Able to take bactrim

          -  Female of childbearing potential must have a negative serum or urine pregnancy test

        Exclusion Criteria:

          -  Renal insufficiency

          -  Concommitant therapy medications that include corticosteroids or other chemotherapy
             that is or may be active against myeloma or therapy with chemotherapy within 2 weeks
             prior to day 1. Nitrosoureas must be discontinued 6 weeks prior to day 1. Concurrent
             radiation therapy is not permitted.

          -  Subjects with evidence of mucosal or internal bleeding and/or platelet refractory

          -  Subjects with poorly controlled diabetes mellitus

          -  Subjects with an ANC < 10-00 cells/mm3

          -  Subjects with a hemoglobin < 8.0 g/Dl

          -  AST (SGOT and ALT (SGPT) greater or equal to 2x ULN

          -  Prior therapy with RAD001

          -  Known hypersensitivity to thalidomide or lenalidomide

          -  Any condition, including laboratory abnormalities, that in the opinion of the
             Investigator, places the subject at unacceptable risk if he/she were to participate in
             the study

          -  Clinically relevant active infection or serious co-morbid medical conditions such as
             recent thromboembolic disease are ineligible if occurred less than 2 weeks prior to
             enrollment or clinically unstable

          -  Chronic obstructive or chronic restrictive pulmonary disease, difficult to control
             diabetes, upper gastrointestinal ulceration, and cirrhosis

          -  Prior malignancy (within the last 3 years) except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ
             prostate cancer or other cancer for which the subject has been disease-free for at
             least 3 years

          -  Pregnant or breast-feeding females

          -  Prior treatment with any investigational drug within preceding 4 weeks

          -  Major surgery, and or radiation with 2 weeks of study initiation

          -  Uncontrolled leptomeningeal disease

          -  Prior treatment with other mTOR inhibitors

          -  The use of G-CSF is not permitted to render the patient eligible fot the study

          -  POEMS syndrome

          -  Known HIV infection

          -  Known active Hepatitis B or C infection

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

          -  Impairment of gastrointestinal function or gastrointestinal disease that may
             significantly alter the absorption of RAD001

          -  Patients with active, bleeding diathesis or on oral anti-vitamin K medication