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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00424047




Registration number
NCT00424047
Ethics application status
Date submitted
17/01/2007
Date registered
18/01/2007
Date last updated
19/10/2017

Titles & IDs
Public title
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Scientific title
The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.
Secondary ID [1] 0 0
CC-5013-MM-010
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 - CC-5013 plus dexamethasone
Treatment: Drugs - Dexamethasone plus Placebo

Experimental: CC-5013 plus dexamethasone - Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle.

Experimental: Dexamethasone plus placebo - Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.


Treatment: Drugs: CC-5013 plus dexamethasone
25 mg daily for 21 days every 28 days.

Treatment: Drugs: Dexamethasone plus Placebo
Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Timepoint [1] 0 0
From randomization up to cut-off date of 03 August 2005; up to 24 months
Primary outcome [2] 0 0
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Timepoint [2] 0 0
From randomization up to cut-off date of 02 March 2008; up to 51 months
Secondary outcome [1] 0 0
Kaplan-Meier Estimate of Overall Survival (OS)
Timepoint [1] 0 0
Randomization to data cut off of 03 August 2005; up to 24 months
Secondary outcome [2] 0 0
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
Timepoint [2] 0 0
Randomization to data cut off of 02 March 2008; up to 51 months
Secondary outcome [3] 0 0
Summary of Myeloma Response Rates Based on Best Response Assessment
Timepoint [3] 0 0
Randomization to 03 August 2005; up to 24 months
Secondary outcome [4] 0 0
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Timepoint [4] 0 0
Randomization to data cut-off of 02 Mar 2008; up to 51 months
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AE)
Timepoint [5] 0 0
From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
Secondary outcome [6] 0 0
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Timepoint [6] 0 0
Up to unblinding data cut off of 03 August 2005; up to 24 months
Secondary outcome [7] 0 0
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Timepoint [7] 0 0
Randomization to cut off date of 03 August 2005; up to 24 months
Secondary outcome [8] 0 0
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
Timepoint [8] 0 0
Randomization to cut off date of 02 March 2008; up to 51 months

Eligibility
Key inclusion criteria
- Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.

- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection
sample).

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2

- Females of childbearing potential must have a negative serum or urine pregnancy test
within 7 days of starting study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior development of disease progression during high-dose dexamethasone containing
therapy

- Pregnant or lactating females

- The development of a desquamating rash while taking thalidomide

- Use of any standard/experimental anti-myeloma therapy within 28 days of randomization
or use of any experimental non-drug therapy within 56 days of initiation of drug
treatment

- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3

- Laboratory abnormalities: Platelet count < 75,000/mm3

- Laboratory abnormalities: Serum creatinine > 2.5 mg/dL

- Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase
(SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase
(SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal

- Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL

- Prior history of malignancies other than multiple myeloma unless the subject has been
free of the disease for = 3 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2013
Sample size
Target
Accrual to date
Final
351
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology - East Melbourne
Recruitment hospital [3] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [4] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Frankston Hospital Oncology Research - Frankston
Recruitment hospital [7] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [9] 0 0
Mater Public Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3006 - East Melbourne
Recruitment postcode(s) [3] 0 0
3121 - Prahran
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment postcode(s) [5] 0 0
VIC 3128 - Box Hill
Recruitment postcode(s) [6] 0 0
VIC 3199 - Frankston
Recruitment postcode(s) [7] 0 0
QLD4029 - Herston
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
QLD 4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussel
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Belgium
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Leuven
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France
State/province [5] 0 0
Chemin Grand Revoyet
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Nantes
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Pessac
Country [10] 0 0
France
State/province [10] 0 0
Toulouse cedex 9
Country [11] 0 0
France
State/province [11] 0 0
Vandoeuvre
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Dusseldorf
Country [14] 0 0
Germany
State/province [14] 0 0
Erlangen
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt am Main
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Germany
State/province [16] 0 0
Heidelberg
Country [17] 0 0
Germany
State/province [17] 0 0
Muenster
Country [18] 0 0
Germany
State/province [18] 0 0
Munchen
Country [19] 0 0
Germany
State/province [19] 0 0
Tubingen
Country [20] 0 0
Greece
State/province [20] 0 0
Athens
Country [21] 0 0
Ireland
State/province [21] 0 0
Co. Galway
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Ireland
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Belfast
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Ireland
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Dublin 8
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Ireland
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Limerick
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Bologna
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Italy
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Genova
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Italy
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Milano
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Italy
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Pavia
Country [33] 0 0
Italy
State/province [33] 0 0
Roma
Country [34] 0 0
Italy
State/province [34] 0 0
Torio
Country [35] 0 0
Italy
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Udine
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Poland
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Gdansk
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Poland
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Lublin
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Poland
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Warsaw
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Salamanca
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Spain
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Santander
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Sweden
State/province [44] 0 0
Goteborg
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Switzerland
State/province [45] 0 0
Lausanne
Country [46] 0 0
Switzerland
State/province [46] 0 0
St. Gallen
Country [47] 0 0
Switzerland
State/province [47] 0 0
Zürich
Country [48] 0 0
Ukraine
State/province [48] 0 0
Cherkassy
Country [49] 0 0
Ukraine
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Dnepropetrovsk
Country [50] 0 0
Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Lvov
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Ukraine
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Odessa
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Ukraine
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Zhitomir
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United Kingdom
State/province [55] 0 0
Bloomsbury
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United Kingdom
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Bristol
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United Kingdom
State/province [57] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose
dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for
subjects with relapsed or refractory multiple myeloma."
Trial website
https://clinicaltrials.gov/ct2/show/NCT00424047
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Knight, MD
Address 0 0
Celgene Corporation
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