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Study to Determine the Maximum Tolerated Dose and Evaluate the Efficacy and Safety of CEP-18770 (Delanzomib) in Patients With Relapsed Multiple Myeloma Refractory to the Most Recent Therapy

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ClinicalTrials.gov Identifier: NCT01023880
Recruitment Status : Terminated
First Posted : December 2, 2009
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Brief Summary:
The primary objective for part 1 of the study is to determine the maximum tolerated dose (MTD) of CEP-18770 in patients with relapsed and refractory multiple myeloma. The primary objective for part 2 is to evaluate the antitumor activity of CEP-18770 in patients treated at the MTD.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CEP-18770 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Maximum Tolerated Dose and Evaluate the Efficacy and Safety of CEP-18770 in Patients With Relapsed Multiple Myeloma Refractory to the Most Recent Therapy
Study Start Date : January 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: 1
CEP-18770
Drug: CEP-18770
CEP-18770 beginning at a dose of 1.5 mg/m2. Patients will receive I.V. administration on days 1, 8, 15 (up to 8 cycles of 28 days each). When the MTD is established, additional patients will be treated at the MTD.
Other Name: delanzomib




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Every 4 weeks, until completion of treatment ]

Secondary Outcome Measures :
  1. Elapsed time from the ORR date to the date of disease progression (DOR) [ Time Frame: at disease progression ]
  2. Elapsed time from the date of first dose of CEP-18770 to the date of first response (TTR) to treatment with CEP-18770 [ Time Frame: at date of first response (TTR) to treatment ]
  3. Elapsed time from the date of first dose of CEP-18770 to the date of disease progression (TTP) [ Time Frame: at date of disease progression (TTP) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

The patient has:

  • relapsed multiple myeloma that has progressed following therapies that included bortezomib and an IMiD (thalidomide or lenalidomide) either alone or in any combination.
  • multiple myeloma, which is refractory to the most recent therapy (bortezomib or IMiD, or any other chemotherapy), or the patient did not tolerate and discontinued the most recent therapy for multiple myeloma but has recovered from its toxic effects.
  • measurable disease defined as 1 of the following:

    • serum M-protein ≥0.5 g/dL
    • urine M-protein ≥200 mg/24 hours
  • a life expectancy of more than 3 months.
  • an ECOG performance status of 0, 1, or 2.
  • adequate hepatic organ function.
  • an absolute neutrophil count (ANC), hemoglobin level, and platelet count within protocol-specific ranges.
  • been independent of granulocyte-colony stimulating factor (G-CSF) or granulocyte macrophage-colony stimulating factor (GM-CSF) support for more than 1 week.
  • been independent of platelet transfusion for more than 1 week.
  • received, or may have received, an allogeneic and/or autologous transplant.
  • a creatinine clearance of 30 mL/minute or more as measured or as calculated based on the Cockcroft-Gault method.
  • if the patient is a female of childbearing potential (not surgically sterile or 1 year postmenopausal): must use a medically accepted method of contraception (including abstinence) and must agree to continue use of this method for the duration of the study and for 3 months after participation in the study.
  • if the patient is a male: is surgically sterile, or if sexually active, is currently using an effective barrier method of contraception, and agrees to continue use of this method for the duration of the study and for 3 months after the last administration of study drug.

Key Exclusion Criteria:

The patient:

  • has nonmeasurable multiple myeloma.
  • received glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 2 weeks prior to the first dose of study drug.
  • has POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy or monoclonal proliferative disorder, and skin changes).
  • has plasma cell leukemia.
  • received chemotherapy with approved anticancer therapeutics within 2 weeks, or within 5 drug half-lives (t1/2), or investigative anticancer therapeutics within 4 weeks, or within 5 drug half-lives (t1/2), before the first dose of study drug, whichever time is greater.
  • received radiation therapy or immunotherapy in the 4 weeks prior to, or localized radiation therapy within 1 week prior to, the first dose of study drug.
  • received prior treatment with CEP-18770.
  • has used a medication known to be a potent inducer of CYP2E1, CYP2D6 or CYP3A4/5 within 4 weeks prior to the first dose of study drug.
  • has used a medication known to be a potent inhibitor of CYP2E1, CYP2D6 or CYP3A4/5 within 2 weeks prior to the first dose of study drug.
  • had major surgery within 3 weeks before the first dose of study drug.
  • has congestive heart failure or had symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within the last 6 months.
  • had an acute infection requiring systemic antibiotics, antiviral agents, or antifungal agents within 2 weeks before the first dose of study drug.
  • has a known or suspected human immunodeficiency virus (HIV) infection on the basis of medical history.
  • had a nonhematologic malignancy within the past 3 years except for the following: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or prostate cancer (Gleason grade <6 with prostate specific antigen (PSA) levels within the normal range).
  • has myelodysplastic or myeloproliferative syndrome.
  • has significant neuropathy.
  • is a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study.
  • has known central nervous system involvement.
  • has any serious psychiatric or medical condition that could interfere with treatment or study procedures, place the patient at unacceptable risk, or hinder the interpretation of study data.
  • has known hypersensitivity to mannitol or hydroxypropyl betadex.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023880


Locations
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United States, Arizona
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
United States, California
Stanford Heme Group
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States
United States, Illinois
Northwestern University Medical School
Chicago, Illinois, United States
United States, Michigan
Henry Ford Health System Protocol Review Committee
Detroit, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States
United States, New Jersey
John Theurer Cancer Center
Hackensack, New Jersey, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Cephalon
Investigators
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Study Director: Sponsor's Medical Expert Cephalon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT01023880     History of Changes
Other Study ID Numbers: C18770/2043
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Delanzomib
Proteasome Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action