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
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
1 other identifier
interventional
62
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Jan 2010
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 11, 2016
March 1, 2016
2.8 years
December 1, 2009
March 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
Every 4 weeks, until completion of treatment
Secondary Outcomes (3)
Elapsed time from the ORR date to the date of disease progression (DOR)
at disease progression
Elapsed time from the date of first dose of CEP-18770 to the date of first response (TTR) to treatment with CEP-18770
at date of first response (TTR) to treatment
Elapsed time from the date of first dose of CEP-18770 to the date of disease progression (TTP)
at date of disease progression (TTP)
Study Arms (1)
1
EXPERIMENTALCEP-18770
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (13)
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Stanford Heme Group
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Northwestern University Medical School
Chicago, Illinois, United States
Henry Ford Health System Protocol Review Committee
Detroit, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Related Publications (1)
Vogl DT, Martin TG, Vij R, Hari P, Mikhael JR, Siegel D, Wu KL, Delforge M, Gasparetto C. Phase I/II study of the novel proteasome inhibitor delanzomib (CEP-18770) for relapsed and refractory multiple myeloma. Leuk Lymphoma. 2017 Aug;58(8):1872-1879. doi: 10.1080/10428194.2016.1263842. Epub 2017 Jan 31.
PMID: 28140719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sponsor's Medical Expert
Cephalon
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 2, 2009
Study Start
January 1, 2010
Primary Completion
November 1, 2012
Study Completion
January 1, 2013
Last Updated
April 11, 2016
Record last verified: 2016-03