Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma Read More

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)