RAD001 and Lenalidomide in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

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