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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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) - Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
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) - Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
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) - OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
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) - OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
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 - Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for = 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to = 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
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) - Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for = 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to = 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
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) - An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
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) - Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy 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 - The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
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) - The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
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
Gender
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
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)
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
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
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
Country [16] 0 0
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
Country [22] 0 0
Ireland
State/province [22] 0 0
Belfast
Country [23] 0 0
Ireland
State/province [23] 0 0
Dublin 8
Country [24] 0 0
Ireland
State/province [24] 0 0
Limerick
Country [25] 0 0
Israel
State/province [25] 0 0
Haifa
Country [26] 0 0
Israel
State/province [26] 0 0
Jerusalem
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Aviv
Country [28] 0 0
Israel
State/province [28] 0 0
Tel Hashomer
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Italy
State/province [30] 0 0
Genova
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
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
State/province [35] 0 0
Udine
Country [36] 0 0
Poland
State/province [36] 0 0
Gdansk
Country [37] 0 0
Poland
State/province [37] 0 0
Lublin
Country [38] 0 0
Poland
State/province [38] 0 0
Warsaw
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Pamplona
Country [42] 0 0
Spain
State/province [42] 0 0
Salamanca
Country [43] 0 0
Spain
State/province [43] 0 0
Santander
Country [44] 0 0
Sweden
State/province [44] 0 0
Goteborg
Country [45] 0 0
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
State/province [49] 0 0
Dnepropetrovsk
Country [50] 0 0
Ukraine
State/province [50] 0 0
Kiev
Country [51] 0 0
Ukraine
State/province [51] 0 0
Lviv
Country [52] 0 0
Ukraine
State/province [52] 0 0
Lvov
Country [53] 0 0
Ukraine
State/province [53] 0 0
Odessa
Country [54] 0 0
Ukraine
State/province [54] 0 0
Zhitomir
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Bloomsbury
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Bristol
Country [57] 0 0
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/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

Summary results
Other publications