| Exclusion Criteria: | 1) Patient had a prior allogeneic bone marrow transplant or plans to undergo autologous or allogeneic bone marrow transplantation within 4 weeks of the initiation of vorinostat administration.
2) Patient had prior treatment with an HDAC inhibitor (e.g., Depsipeptide, MS-275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781, etc.). Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not be enrolled in this study. Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period.
3) Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the combination therapy.
4) Pt has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including, but not limited to the following: active systemic infection, acute or chronic graft versus host disease, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within past 6 months, uncontrolled cardiac arrhythmia, renal failure, psychiatric or social conditions that may interfere with pt compliance,
5) Continued from Exclusion # 4: or any other condition (including laboratory abnormalities) that in the opinion of the Investigator places the pt at unacceptable risk for adverse outcome if he/she were to participate in the study
6) Patient has received intravenous (I.V.) antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug.
7) Patient has known hypersensitivity to lenalidomide, thalidomide, dexamethasone, or components of vorinostat.
8) Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse.
9) Patient is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study.
10) Patient is known to be Human Immunodeficiency Virus (HIV) positive.
11) Patient with known history of Hepatitis B and/or C infection.
12) Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; non-melanoma skin cancer; adequately treated localized prostate carcinoma with prostate specific antigen (PSA) < 0.1; or who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician.
13) Patient with plasma cell leukemia defined as the presence of more than 20% plasma cells in the peripheral blood and an absolute plasma cell count of at least 2000 microL.
14) Patient with known history of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
15) Patient has a history of a gastrointestinal surgery or other procedures that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the study drugs.
16) Patient who received lenalidomide within 3 months prior to the first dose. |