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
NCT ID: NCT01023880
Last Updated: 2016-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
62 participants
INTERVENTIONAL
2010-01-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma
NCT01866293
Study of High Dose Carfilzomib in Multiple Myeloma Patients Who Have Progressed On Standard Dose Carfilzomib
NCT01775553
Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma
NCT04975399
An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma
NCT00402181
A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma
NCT00429949
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
CEP-18770
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cephalon
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sponsor's Medical Expert
Role: STUDY_DIRECTOR
Cephalon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C18770/2043
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.