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

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine the maximum tolerated dose (MTD) of CEP-18770 in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon
• Treatments: BB 1101; Delanzomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

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.