Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• The participant is a man or woman at least 18 years of age with documented multiple myeloma.
• The participant has relapsed or progressive disease after receiving at least 1 previous chemotherapy treatment but no more than 5 previous therapies.
• The participant has measurable disease defined as 1 of the following:
• serum M-protein 0.5 grams (g)/deciliter (dL) or greater
• urine M-protein 200 mg/24 hours or greater
• The participant has a life expectancy of more than 3 months.
• Written informed consent is obtained.
• The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• The participant has adequate hepatic and renal function and hematologic assessments as specified by the study protocol
• The participant 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 participant has been independent of platelet transfusions for 1 week at the time of screening.
• The participant may have received an allogeneic and/or autologous transplant.
• The participant 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 (for example, intrauterine device [IUD], non-combination hormonal contraception, tubal ligation, or partner's vasectomy) and one additional method (for example, 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 participant may not donate blood, semen or sperm while taking lenalidomide or for 4 weeks after the last administration of lenalidomide.
• The participant may not breastfeed while taking lenalidomide or for 4 weeks after the last administration of lenalidomide.

Exclusion Criteria

• The participant 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 participant could not tolerate previous lenalidomide or low-dose dexamethasone treatment.
• The participant had previous treatment with CEP-18770.
• The participant 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 participant has plasma cell leukemia or primary amyloidosis.
• The participant received chemotherapy with approved or investigative anticancer therapeutics within 3 weeks before the first dose of study drug.
• The participant received radiation therapy or immunotherapy within 4 weeks or localized radiation therapy within 1 week prior to the first dose of study drug.
• The participant had major surgery within 3 weeks before the first dose of study drug.
• The participant 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 participant had an acute infection requiring systemic antibiotics, antiviral agents, or antifungal agents within 2 weeks before the first dose of study drug.
• The participant has a known or suspected human immunodeficiency virus (HIV) infection,