Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Cancer, Multiple myeloma, CEP-18770, Lenalidomide, Dexamethasone
Eligibility 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.
Sites / Locations
- Teva Investigational Site 1
- Teva Investigational Site 3
- Teva Investigational Site 2
- Teva Investigational Site 201
- Teva Investigational Site 204
- Teva Investigational Site 200
- Teva Investigational Site 206
- Teva Investigational Site 205
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
CEP-18770 Dose A
CEP-18770 Dose B
CEP-18770 Dose C
Participants will receive CEP-18770 Dose A intravenously (IV) on Days 1, 8, and 15 in each 28-day cycle. In addition, participants will receive a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
Participants will receive CEP-18770 Dose B IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants will receive a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.
Participants will receive CEP-18770 Dose C IV on Days 1, 8, and 15 in each 28-day cycle. In addition, participants will receive a fixed dose of 25 mg oral lenalidomide on Days 1 through 21 and a fixed dose of 40 mg oral dexamethasone on Days 1, 8, 15, and 22 of each 28-day cycle.