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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01539083
Registration number
NCT01539083
Ethics application status
Date submitted
23/11/2011
Date registered
27/02/2012
Date last updated
27/12/2018
Titles & IDs
Public title
Velcade (Bortezomib) Consolidation After Transplant
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Scientific title
An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant
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Secondary ID [1]
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26866138-MMY-2073
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Secondary ID [2]
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CR018751
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Universal Trial Number (UTN)
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Trial acronym
VCAT
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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 - Thalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Prednisolone
Experimental: Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction] - Bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
Experimental: Thalidomide + Prednisolone [TP Consolidation] - Thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
Experimental: Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] - Bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
Treatment: Drugs: Thalidomide
Thalidomide 100 mg tablet, orally.
Treatment: Drugs: Bortezomib
Bortezomib 1.3 milligram per square meter (mg/m\^2) solution for injection subcutaneously (SC).
Treatment: Drugs: Cyclophosphamide
Cyclophosphamide 300 mg/m\^2 orally.
Treatment: Drugs: Dexamethasone
Dexamethasone 20 mg orally.
Treatment: Drugs: Prednisolone
Prednisolone 50 mg orally.
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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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Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12
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Assessment method [1]
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CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level \<100 milligram (mg) per 24 hours.
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Timepoint [1]
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Month 12
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Secondary outcome [1]
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Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
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Assessment method [1]
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CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.
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Timepoint [1]
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Months 3, 6, 9 and 12
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Secondary outcome [2]
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Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
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Assessment method [2]
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sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow.
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Timepoint [2]
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Months 3, 6, 9 and 12
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Secondary outcome [3]
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Progression Free Survival (PFS)
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Assessment method [3]
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PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of \>= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be \>=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
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Timepoint [3]
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Baseline until progressive disease (up to 5 years)
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Secondary outcome [4]
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Disease-free Survival (DFS)
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Assessment method [4]
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DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of \>= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
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Assessment method [6]
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The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).
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Timepoint [6]
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Baseline, Month 12
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Secondary outcome [7]
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Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase
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Assessment method [7]
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Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.
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Timepoint [7]
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Baseline, Month 12
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Previously diagnosed with multiple myeloma based on international myeloma working group (IMWG) criteria.and meet all of the following; Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter); Urine M-protein >=200 milligram (mg) per 24 hour and Serum Free Light chain (FLC) assay: Involved FLC Level >=10 mg/dL (>=100 mg/L) provided serum FLC ratio is normal
* Meet the pretreatment laboratory criteria as specified in the study protocol at and within 21 days before baseline (Day 1 of Cycle 1, before bortezomib administration for induction).
* Have ECOG status 0-2.
* Men and women must practice an appropriate method of birth control as specified in the study protocol from signing of the informed consent form though to the 12-month visit/early termination visit.
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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
Exclusion criteria:
* Has previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone) as specified in the study protocol.
* Has a history of any other malignancy within 5 years before enrolment as specified in the study protocol.
* Has had major surgery as specified in the study protocol within 30 days before enrolment.
* Had a myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or IV heart failure (or other clinically significant cardiac medical history as specified in the study protocol).
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
13/01/2012
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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
9/01/2018
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Sample size
Target
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Accrual to date
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Final
256
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Camperdown
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Recruitment hospital [3]
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- Geelong
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Recruitment hospital [4]
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- Greenslopes
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Recruitment hospital [5]
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- Heidelberg
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Recruitment hospital [6]
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- Herston
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Recruitment hospital [7]
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- Malvern
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Recruitment hospital [8]
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- Melbourne
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Recruitment hospital [9]
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- Nedlands
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Recruitment hospital [10]
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- Newcastle
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Recruitment hospital [11]
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- Prahran
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Recruitment hospital [12]
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- Sydney
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Recruitment hospital [13]
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- Westmead
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Recruitment hospital [14]
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- Woodville South
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Recruitment hospital [15]
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- Woolloongabba
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Camperdown
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Recruitment postcode(s) [3]
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- Geelong
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Recruitment postcode(s) [4]
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- Greenslopes
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Recruitment postcode(s) [5]
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- Heidelberg
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Recruitment postcode(s) [6]
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- Herston
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Recruitment postcode(s) [7]
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- Malvern
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Recruitment postcode(s) [8]
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- Melbourne
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Recruitment postcode(s) [9]
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- Nedlands
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Recruitment postcode(s) [10]
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- Newcastle
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Recruitment postcode(s) [11]
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- Prahran
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Recruitment postcode(s) [12]
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- Sydney
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Recruitment postcode(s) [13]
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- Westmead
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Recruitment postcode(s) [14]
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- Woodville South
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Recruitment postcode(s) [15]
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- Woolloongabba
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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Guangzhou
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Country [3]
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China
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State/province [3]
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Shanghai
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Country [4]
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China
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State/province [4]
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Tianjin
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Country [5]
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Korea, Republic of
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State/province [5]
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Busan
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Country [6]
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Korea, Republic of
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State/province [6]
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Daegu
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Country [7]
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Korea, Republic of
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State/province [7]
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Hwasun Gun
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Country [8]
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Korea, Republic of
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State/province [8]
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Ulsan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Scientific Affairs, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.
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Trial website
https://clinicaltrials.gov/study/NCT01539083
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Trial related presentations / publications
Horvath N, Spencer A, Kenealy M, Joshua D, Campbell PJ, Lee JJ, Hou J, Qiu L, Kalff A, Khong T, Londhe A, Siggins S, van Kooten Losio M, Eisbacher M, Prince HM. Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study. Leuk Lymphoma. 2019 Sep;60(9):2122-2133. doi: 10.1080/10428194.2019.1579322. Epub 2019 Feb 19.
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Public notes
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Contacts
Principal investigator
Name
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Janssen Asia-Pacific Medical Affairs Clinical Trial
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Address
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Janssen Asia-Pacific Medical Affairs
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01539083
Download to PDF