Intervention: Everolimus
Trial phase: Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: RAD001, oral, 10 mg, daily

RAD001 : Taken orally once a day
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Adequate liver and renal function as outlined in the protocol
Fasting serum cholesterol 300mg/dl or less OR 7.75mmol/L or less AND fasting triglycerides 2.5 x institutional ULN or less.
Clinicopathological diagnosis of Waldenstrom's macroglobulinemia as defined by consensus panel of the Second International Workshop on Waldenstrom's macroglobulinemia
No previous therapy for WM
Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of 2 times the upper limit of each institution's normal value or greater is required
ECOG Performance status of 0-2
Patients must have a life expectancy of at least 3 months
Baseline platelet and absolute neutrophil as outlined in the protocol
INR and PTT 1.5 x normalized ratio or less
A male subject agrees to use an acceptable method for contraception for the duration of study and for 8 weeks after the last dose of the study drug
Female subject either post-menopausal or surgically sterilized or willing to use acceptable methods of birth control for the duration of the study and for 8 weeks after the last dose of study drug

Exclusion Criteria:

Patients experiencing symptomatic hyperviscosity and requiring plasmapheresis. This includes any patient who, in the judgement of the investigator requires urgent response and will not be eligible. These patients have hyperviscosity which includes serum IgM levels of 5000 mg/dL or greater. Symptoms may include nosebleeds, visual complications, fatigue, headaches, confusion, etc.
Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study.
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
Patients should not receive any immunization with attenuated live vaccines within one week of study entry or during study period.
Patients who have had any severe and/or uncontrolled medical conditions or other conditions that would affect their participation in the study.
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001.
Female patients that are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
Patients with other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell of the skin
Patients with known history of HIV seropositivity
History of noncompliance to medical regimens
Patients unwilling to or unable to comply with the protocol