Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed multiple
myeloma.(smoldering myeloma and symptomatic multiple myeloma).

- Patients must have measurable disease and therefore must have at least one of the
following:

- Serum M-protein ≥1 gm/dL (>=10 gm/L)

- Urine M-protein ≥200 mg/24 hr

- Serum FLC assay: involved FLC >=10 mg/dL (>= 100 mg/L) provided serum FLC ratio
is abnormal.

- Male or female >= 18 years of age.

- Life expectancy of >= 6 months.

- ECOG performance status < 2.

- Normal organ and marrow function as defined below:

- Absolute Neutrophil Count (ANC) > 1,000/mm3

- Platelets >= 75,000/mm3

- Hemoglobin >= 8 g/dL

- Calculated serum creatinine (calculated by Cockroft-Gault method) >= 30 mL/min

- AST(SGOT)/ALT(SGPT) =< 2.5 X ULN

- Total bilirubin =< 1.5 X ULN

- Patient must be at least 2 weeks from prior chemotherapy, radiation therapy,
biological therapy, immunotherapy, major surgery and any other investigational
anti-cancer therapy prior to the first dose of study drug.

- Patient has recovered from toxicities (< Grade 2) and/or complications from prior
therapy.

- Patient is able to swallow capsules and is able to take or tolerate oral medications
on a continuous basis.

- Female patients of childbearing potential must be willing to use 2 adequate barrier
methods of contraception to prevent pregnancy or agrees to abstain from heterosexual
intercourse for at least 1 month before dosing, and while women are on study and for
up to 12 weeks after last dose of study drug. Adequate contraceptive methods include
intrauterine device, diaphragm with spermicide, cervical cap with spermicide, or
female condom with spermicide. Spermicides alone are not an acceptable method of
contraception.

- Male patients agree to have female partners of childbearing potential use 2 adequate
barrier methods of contraception as described in Section 3.1.10.

- Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to the first dose of study drug.

- Patient is available for periodic blood sampling, study related assessments and
management at the treating institution for the duration of the study.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Patients who only present with isolated plasmacytomas

- Inability to swallow oral medication.

- Prior allogeneic stem cell transplant (subject with prior autologous transplant is
eligible).

- Patient has plans to undergo any type of stem cell transplantation (allogeneic or
autologous) within 4 weeks of initiation of study therapy.

- Concurrent therapy with HMG-CoA Reductase Inhibitors.

- Patient with gallbladder disease or cholelithiasis.

- Patient has active liver disease, including biliary cirrhosis and unexplained liver
function abnormalities.

- Patients receiving renal dialysis.

- History of hypersensitivity to fenofibrate or fenofibric acid, including sever skin
rashes (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)

- Patients who would be receiving any other investigational agents while on study.

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patient has systemic infection requiring treatment.

- Patient has acute diffuse infiltrative pulmonary disease or pericardial disease.

- Subject is receiving corticosteroid therapy (> 10 mg of prednisone or equivalent).

- Subject is a regular user or has a recent history (within the last year) of any
illicit drugs, or substance abuse.

- Subject is pregnant or breast feeding, or expecting to conceive or father children
within the projected duration of the study.

- Subject is known to be HIV positive.

- Subject has clinically active Hepatitis B or C

- History of prior malignancy except for cervical carcinoma in situ, non-melanoma skin
cancer, adequately treated localized prostate cancer with PSA < 0.1, or has undergone
potentially curative therapy with no evidence of disease for five years, or who is
deemed at low risk for recurrence by his/her treating physician.

- Patient with CNS metastases and/or carcinomatous meningitis.

- History of gastrointestinal disease that could potentially impact the ability of the
patient to swallow and/or absorb study drug (i.e., gastrointestinal surgery,
malabsorption syndrome, subjects requiring the use of feeding tube)

- History of gastrointestinal surgery or other procedures that might in the opinion of
the investigator interfere with swallowing and/or absorption of the study drug.