Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma

- Has undergone melphalan-conditioned autologous peripheral blood stem cell
transplant myeloma.

PATIENT CHARACTERISTICS:

- ECOG/WHO performance status 0-2

- ANC ≥ 1,000/mm³

- Platelet count ≥ 75,000/mm³

- Total bilirubin ≤ 2 times upper limit of normal (ULN)

- AST and ALT ≤ 2 times ULN

- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 90 days after
completion of study treatment

- No blood, sperm, or ova donation during and for ≥ 4 weeks after completion of study
treatment

- Able to obtain commercially available lenalidomide via Celegene's RevAssist® program

- Registered in the RevAssist® program

- Willing and able to comply with the requirements of RevAssist®

- Able to swallow capsules

- No severe or uncontrolled systemic illness

- No "currently active" second malignancy, other than nonmelanoma skin cancer or
carcinoma in situ of the cervix

- Patients are not considered to have a "currently active" malignancy if they
completed therapy for the malignancy, are disease free from the malignancy for >
5 years, and are considered by their physician to be at < 30% risk of relapse

- No congenital long QT syndrome

- No drug or alcohol abuse within the past 12 months

- No history of allergic reactions (including erythema nodosum) attributed to compounds
of similar chemical or biologic composition to lenalidomide, thalidomide, or
vorinostat

- No other medical condition, including mental illness or substance abuse, deemed by
the investigator(s) to likely interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the study results

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since prior class Ia, Ib, or Ic antiarrhythmic medication

- No prior HDAC inhibitor-like compounds (e.g., valproic acid) as anticancer therapy

- More than 30 days since prior HDAC inhibitor-like compounds for other indications
(e.g., valproic acid for epilepsy)

- No prior gastrointestinal surgery or other procedure that may, in the opinion of the
investigator, interfere with the absorption or swallowing of the study drugs

- No concurrent corticosteroids other than for physiologic maintenance treatment

- No concurrent radiotherapy, unless for local control of bone pain

- Irradiated area should be as small as possible

- Lesions within the irradiated field cannot be used for response assessment

- No concurrent use of complementary or alternative medicines that would confound the
interpretation of toxicities and anticancer activity of the study drugs

- No other concurrent anticancer therapy, including chemotherapy or biologic therapy

- No other concurrent HDAC inhibitors (e.g., valproic acid)