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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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.
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Secondary ID [1]
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CC-5013-MM-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization up to cut-off date of 03 August 2005; up to 24 months
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Primary outcome [2]
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Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization up to cut-off date of 02 March 2008; up to 51 months
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Secondary outcome [1]
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Kaplan-Meier Estimate of Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization to data cut off of 03 August 2005; up to 24 months
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Secondary outcome [2]
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Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
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Assessment method [2]
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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.
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Timepoint [2]
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Randomization to data cut off of 02 March 2008; up to 51 months
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Secondary outcome [3]
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Summary of Myeloma Response Rates Based on Best Response Assessment
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Assessment method [3]
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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.
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Timepoint [3]
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Randomization to 03 August 2005; up to 24 months
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Secondary outcome [4]
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Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
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Assessment method [4]
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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.
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Timepoint [4]
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Randomization to data cut-off of 02 Mar 2008; up to 51 months
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Secondary outcome [5]
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Number of Participants With Adverse Events (AE)
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Assessment method [5]
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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.
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Timepoint [5]
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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
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Secondary outcome [6]
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Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
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Assessment method [6]
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Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).
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Timepoint [6]
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Up to unblinding data cut off of 03 August 2005; up to 24 months
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Secondary outcome [7]
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Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
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Assessment method [7]
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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.
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Timepoint [7]
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Randomization to cut off date of 03 August 2005; up to 24 months
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Secondary outcome [8]
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Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
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Assessment method [8]
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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.
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Timepoint [8]
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Randomization to cut off date of 02 March 2008; up to 51 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/11/2013
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Sample size
Target
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Accrual to date
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Final
351
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology - East Melbourne
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The Alfred Hospital - Prahran
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Border Medical Oncology - Wodonga
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Box Hill Hospital - Box Hill
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Frankston Hospital Oncology Research - Frankston
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Royal Brisbane Hospital - Herston
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The Royal Melbourne Hospital - Parkville
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Mater Public Hospital - South Brisbane
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2050 - Camperdown
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3006 - East Melbourne
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3121 - Prahran
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3690 - Wodonga
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VIC 3128 - Box Hill
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VIC 3199 - Frankston
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QLD4029 - Herston
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3050 - Parkville
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Recruitment postcode(s) [9]
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QLD 4101 - South Brisbane
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Recruitment outside Australia
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Austria
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Salzburg
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Austria
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Vienna
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Brussel
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Leuven
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Chemin Grand Revoyet
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Lille
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Nantes
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France
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Paris
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Pessac
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France
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Toulouse cedex 9
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France
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Vandoeuvre
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Germany
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Berlin
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Frankfurt am Main
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Heidelberg
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Tel Aviv
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Israel
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Italy
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Torio
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Italy
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Barcelona
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Zürich
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Cherkassy
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Dnepropetrovsk
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Odessa
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Zhitomir
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Bloomsbury
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celgene
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Ethics approval
Ethics application status
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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."
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Trial website
https://clinicaltrials.gov/study/NCT00424047
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Trial related presentations / publications
Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544. San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120. Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9. Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.
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Public notes
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Contacts
Principal investigator
Name
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Robert Knight, MD
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Address
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Celgene Corporation
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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
Type
Citations or Other Details
Journal
Dimopoulos M, Spencer A, Attal M, Prince HM, Harou...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00424047
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