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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01348919




Registration number
NCT01348919
Ethics application status
Date submitted
4/05/2011
Date registered
6/05/2011
Date last updated
28/06/2023

Titles & IDs
Public title
Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Scientific 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
Secondary ID [1] 0 0
2010-020910-27
Secondary ID [2] 0 0
C18770/2049
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CEP-18770
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone

Experimental: CEP-18770 Dose A - 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.

Experimental: CEP-18770 Dose B - 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.

Experimental: CEP-18770 Dose C - 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.


Treatment: Drugs: CEP-18770
CEP-18770 will be administered per dose and schedule specified in the arm description.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered per dose and schedule specified in the arm description.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered per dose and schedule specified in the arm description.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) in Participants Treated at the (Maximum Tolerated Dose) MTD, as Assessed Using International Myeloma Working Group (IMWG) Criteria
Timepoint [1] 0 0
From the first administration of CEP-18770 up to approximately 1.5 years
Primary outcome [2] 0 0
Maximum Tolerated Dose of CEP-18770
Timepoint [2] 0 0
Cycle 1 (28 days)
Secondary outcome [1] 0 0
Duration of Response (DOR) for Participants Treated With CEP-18770 at the MTD, as Assessed Using IMWG Criteria
Timepoint [1] 0 0
From the date of first response to the date of disease progression (up to approximately 1.5 years)
Secondary outcome [2] 0 0
Time to Progression (TTP) for Participants Treated With CEP-18770 at the MTD, as Assessed Using IMWG Criteria
Timepoint [2] 0 0
From the date of first dose of study drug to the date of disease progression (up to approximately 1.5 years)
Secondary outcome [3] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [3] 0 0
From the first administration of CEP-18770 up to approximately 1.5 years
Secondary outcome [4] 0 0
Maximum Observed Plasma Concentration (Cmax) of CEP-18770
Timepoint [4] 0 0
Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1
Secondary outcome [5] 0 0
Time to Reach Cmax (Tmax) of CEP-18770
Timepoint [5] 0 0
Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1
Secondary outcome [6] 0 0
Area Under the Plasma Concentration-Time Curve From Time 0 to t (AUC0-t) of CEP-18770
Timepoint [6] 0 0
Before and immediately after end of infusion (EOI) and at approximately 2, 4, and 8 hours after the EOI on Days 1 and 15 of Cycle 1

Eligibility
Key inclusion criteria
* The participant is a man or woman at least 18 years of age with documented multiple myeloma.
* The participant has relapsed or progressive disease after receiving at least 1 previous chemotherapy treatment but no more than 5 previous therapies.
* The participant has measurable disease defined as 1 of the following:
* serum M-protein 0.5 grams (g)/deciliter (dL) or greater
* urine M-protein 200 mg/24 hours or greater
* The participant has a life expectancy of more than 3 months.
* Written informed consent is obtained.
* The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* The participant has adequate hepatic and renal function and hematologic assessments as specified by the study protocol
* The participant 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 participant has been independent of platelet transfusions for 1 week at the time of screening.
* The participant may have received an allogeneic and/or autologous transplant.
* The participant 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 (for example, intrauterine device [IUD], non-combination hormonal contraception, tubal ligation, or partner's vasectomy) and one additional method (for example, 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 participant may not donate blood, semen or sperm while taking lenalidomide or for 4 weeks after the last administration of lenalidomide.
* The participant may not breastfeed while taking lenalidomide or for 4 weeks after the last administration of lenalidomide.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The participant 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 participant could not tolerate previous lenalidomide or low-dose dexamethasone treatment.
* The participant had previous treatment with CEP-18770.
* The participant 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 participant has plasma cell leukemia or primary amyloidosis.
* The participant received chemotherapy with approved or investigative anticancer therapeutics within 3 weeks before the first dose of study drug.
* The participant received radiation therapy or immunotherapy within 4 weeks or localized radiation therapy within 1 week prior to the first dose of study drug.
* The participant had major surgery within 3 weeks before the first dose of study drug.
* The participant 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 participant had an acute infection requiring systemic antibiotics, antiviral agents, or antifungal agents within 2 weeks before the first dose of study drug.
* The participant 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 participant has myelodysplastic or myeloproliferative syndrome.
* The participant has significant neuropathy (at least grade 2, or grade 1 with pain).
* The participant is a pregnant or lactating woman.
* The participant has known hypersensitivity to CEP-18770, lenalidomide, thalidomide, dexamethasone, mannitol, or hydroxypropyl betadex.
* The participant received glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 2 weeks prior to the first dose of study drug.
* The participant 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 participant has known central nervous system (CNS) involvement.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2013
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
New Zealand
State/province [6] 0 0
Hamilton
Country [7] 0 0
New Zealand
State/province [7] 0 0
Newtown

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert
Address 0 0
Teva Branded Pharmaceutical Products R&D, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01348919