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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01348919
Ethics application status
Date submitted
4/05/2011
Date registered
6/05/2011
Date last updated
21/07/2016

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 in Combination With Lenalidomide and Dexamethasone -


Treatment: Drugs: CEP-18770
administered on days 1, 8, and 15 of each 28-day cycle

Treatment: Drugs: Lenalidomide
administered 25 mg on days 1 through 21 of each 28-day cycle

Treatment: Drugs: Dexamethasone
administered 40 mg on days 1, 8, 15, and 22 of each 28-day cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The patient's best response to treatment with CEP-18770 in combination with lenalidomide and dexamethasone - The primary efficacy variable is the overall response rate (ORR) defined as the number of patients in the full analysis set achieving a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) during the study divided by the total number of patients in the full analysis set.
Timepoint [1] 0 0
Baseline to endpoint (defined as a maximum of 1 year after first administration of CEP-18770 or until disease progression)
Primary outcome [2] 0 0
Determination of the maximum tolerated dose (MTD) of CEP-18770 in combination with lenalidomide and dexamethasone in patients with refractory or relapsed multiple myeloma - The maximum tolerated dose will be determined based on the observation of dose limiting toxicities during cycle 1 of each dosing cohort.
Timepoint [2] 0 0
Days 1 to 28 of cycle 1
Secondary outcome [1] 0 0
Time interval from the date of first response to the date of disease progression
Timepoint [1] 0 0
baseline to endpoint (defined as a maximum of 1 year after first administration of CEP-18770 or until disease progression)
Secondary outcome [2] 0 0
Time interval from the date of first dose to the date of disease progression
Timepoint [2] 0 0
Baseline to endpoint (defined as a maximum of 1 year after first administration of CEP-18770 or until disease progression)
Secondary outcome [3] 0 0
Evaluation of the safety and tolerability of CEP-18770 in combination with lenalidomide and dexamethasone - Assessed by the occurrence of adverse events, clinical laboratory test results, vital sign measurements, electrocardiogram (ECG) findings, physical examination findings, and concomitant medication usage.
Timepoint [3] 0 0
During the entire study treatment period of approximately 48 weeks (twelve 28-day cycles)
Secondary outcome [4] 0 0
Cmax pharmacokinetic parameter - maximum observed drug concentration (Cmax)
Timepoint [4] 0 0
Cycle 1 days 1, 8, and 15 in Part 1 and Days 1, 3, 8, 15, and days 17 to 19 in Part 2
Secondary outcome [5] 0 0
tmax pharmacokinetic parameter - time to maximum observed drug concentration (tmax)
Timepoint [5] 0 0
Cycle 1 days 1, 8, and 15 in Part 1 and Days 1, 3, 8, 15, and days 17 to 19 in Part 2
Secondary outcome [6] 0 0
AUC pharmacokinetic parameter - area under the plasma concentration-time curve (AUC)
Timepoint [6] 0 0
Cycle 1 days 1, 8, and 15 in Part 1 and Days 1, 3, 8, 15, and days 17 to 19 in Part 2

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [8] 0 0
New Zealand
State/province [8] 0 0
Palmerston North
Country [9] 0 0
New Zealand
State/province [9] 0 0
Takapuna

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cephalon
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01348919
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sponsor's Medical Expert, Medical Director - Clinical Research Oncology
Address 0 0
Cephalon
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01348919