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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: CEP-18770 (Drug); Lenalidomide (Drug); Dexamethasone (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Cephalon

Official(s) and/or principal investigator(s):
Sponsor's Medical Expert, Medical Director - Clinical Research Oncology, Study Director, Affiliation: Cephalon

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The patient's best response to treatment with CEP-18770 in combination with lenalidomide and dexamethasone

Determination of the maximum tolerated dose (MTD) of CEP-18770 in combination with lenalidomide and dexamethasone in patients with refractory or relapsed multiple myeloma

Secondary outcome:

Time interval from the date of first response to the date of disease progression

Time interval from the date of first dose to the date of disease progression

Evaluation of the safety and tolerability of CEP-18770 in combination with lenalidomide and dexamethasone

Cmax pharmacokinetic parameter

tmax pharmacokinetic parameter

AUC pharmacokinetic parameter

Detailed description: After cycle 1, the start of treatment in each cycle may occur within a 3-day window. In addition, after cycle 2, the start of treatment in cycle 3 may be delayed by 1 week if, in the opinion of the investigator, the delay is warranted. If a patient cannot receive 75% of the planned dose for any of the 3 agents (missing more than 1 dose of CEP-18770, or more than 5 doses of lenalidomide [either consecutively or separately], or more than 1 dose of dexamethasone [either consecutively or separately]), due to a drug-related adverse event, the event will be considered a dose limiting toxicity (DLT), even if the grade of toxicity is lower than specified DLT determination. Patients will receive intravenous (IV) CEP-18770 on days 1, 8, and 15, oral lenalidomide on days 1 through 21, and oral dexamethasone on days 1, 8, 15, and 22 of each 28-day cycle. Treatment with all 3 drugs will continue for up to 12 cycles (approximately 11 months), or until disease progression or intolerable toxicities. Patients experiencing clinical benefit may continue to receive additional treatment at the investigator's discretion and following sponsor notification. In part 2 of the study, patients will receive CEP-18770 as a slow IV bolus (approximately 1 milliliter per minute) at the maximum tolerated dose on days 1, 8, and 15 of every 28-day cycle. Patients who complete or discontinue study drug treatment and whose disease has not progressed will have study visits every 7-9 weeks during follow-up until disease progression, death, or until they have been monitored for 1 year after the first administration of study drug, whichever occurs first.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Teva Investigational Site 201, Auckland, New Zealand

Teva Investigational Site 204, Auckland, New Zealand

Teva Investigational Site 200, Christchurch, New Zealand

Teva Investigational Site 206, Hamilton, New Zealand

Teva Investigational Site 205, Newtown, New Zealand

Teva Investigational Site 202, Palmerston North, New Zealand

Teva Investigational Site 203, Takapuna, New Zealand

Teva Investigational Site 1, Augusta, Georgia, United States

Teva Investigational Site 3, Lexington, Kentucky, United States

Teva Investigational Site 2, Houston, Texas, United States

Additional Information

Starting date: August 2011
Last updated: August 30, 2013

Page last updated: August 23, 2015

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