An Open-Label Study to Determine the Maximum Tolerated Dose and Evaluate the Safety and Efficacy of CEP-18770 in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria:

- The patient is a man or woman at least 18 years of age with documented multiple
myeloma.

- The patient has relapsed or progressive disease after receiving at least 1 previous
chemotherapy treatment but no more than 5 previous therapies.

- The patient has measurable disease defined as 1 of the following:

- serum M-protein 0.5 g/dL or greater

- urine M-protein 200 mg/24 hours or greater

- The patient has a life expectancy of more than 3 months.

- Written informed consent is obtained.

- The patient has an ECOG performance status of 0, 1, or 2.

- The patient has adequate hepatic and renal function and hematologic assessments as
specified by the study protocol

- The patient has been independent of support with granulocyte-colony stimulating
factor (G-CSF) or granulocyte macrophage-colony stimulating factor (GM-CSF) for more
than 1 week at the time of screening.

- The patient has been independent of platelet transfusions for 1 week at the time of
screening.

- The patient may have received an allogeneic and/or autologous transplant.

- The patient must agree to register into the mandatory risk evaluation and mitigation
program for receiving lenalidomide if required by local regulations.

- Agreement by women of childbearing potential (not surgically sterile or 24 months
postmenopausal) to use 2 medically accepted methods of contraception and must agree
to continue use of these methods from 4 weeks prior to treatment to 4 weeks after
treatment. Acceptable methods of contraception include at least one highly effective
method (e.g., intrauterine device [IUD], non-combination hormonal contraception,
tubal ligation, or partner's vasectomy) and one additional method (e.g., latex
condom, diaphragm, or cervical cap).

- Agreement by men who are sexually active with a woman of childbearing potential (as
defined in the criterion above), to use a condom during any sexual contact for the
duration of the study and for 4 weeks after the last administration of study drug.
This requirement applies even if the man has had a vasectomy.

- The patient may not donate blood, semen or sperm while taking lenalidomide or for 4
weeks after the last administration of lenalidomide.

- The patient may not breastfeed while taking lenalidomide or for 4 weeks after the
last administration of lenalidomide.

Exclusion Criteria:

- The patient has nonmeasurable multiple myeloma, defined as less than 0.5 g/dL
M-protein in the serum, and less than 200 mg/24 hours M-protein in the urine.

- The patient could not tolerate previous lenalidomide or low-dose dexamethasone
treatment.

- The patient had previous treatment with CEP-18770.

- The patient has POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy,
monoclonal gammopathy or monoclonal proliferative disorder, and skin changes
[increased skin pigment, increased body hair, thickening of the skin, whitening of
the nails, etc]).

- The patient has plasma cell leukemia or primary amyloidosis.

- The patient received chemotherapy with approved or investigative anticancer
therapeutics within 3 weeks before the first dose of study drug.

- The patient received radiation therapy or immunotherapy within 4 weeks or localized
radiation therapy within 1 week prior to the first dose of study drug.

- The patient had major surgery within 3 weeks before the first dose of study drug.

- The patient has congestive heart failure (New York Heart Association Class III to IV)
or had symptomatic ischemia, conduction abnormalities uncontrolled by conventional
intervention, or myocardial infarction within the last 6 months.

- The patient had an acute infection requiring systemic antibiotics, antiviral agents,
or antifungal agents within 2 weeks before the first dose of study drug.

- The patient has a known or suspected human immunodeficiency virus (HIV) infection,
acute or chronic hepatitis B virus or hepatitis C virus on the basis of their medical
history.

- The patient has myelodysplastic or myeloproliferative syndrome.

- The patient has significant neuropathy (at least grade 2, or grade 1 with pain).

- The patient is a pregnant or lactating woman.

- The patient has known hypersensitivity to CEP-18770, lenalidomide, thalidomide,
dexamethasone, mannitol, or hydroxypropyl betadex.

- The patient received glucocorticoid therapy (prednisone >10 mg/day orally or
equivalent) within the last 2 weeks prior to the first dose of study drug.

- The patient has a history of malignancy, other than multiple myeloma, within the last
5 years excluding adequately treated curable disease or indolent disease that is not
likely to require therapy during the conduct of the study.

- The patient has known central nervous system (CNS) involvement.