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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-001628-35-GB |
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Date of registration:
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31/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation (MMVAR). - MMVAR
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Scientific title:
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A Randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation (MMVAR). - MMVAR |
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Date of first enrolment:
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22/03/2007 |
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Target sample size:
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452 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001628-35 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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Germany
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Hungary
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
· Male or female =18 years-of-age
· Multiple myeloma with evaluable disease
· Relapsing or having a progressive disease at least one year after an
autologous transplantation
· Karnofsky performance status > 50 %
· Life expectancy of at least 3 months
· Female of child-bearing potential must have a method of birth control
and a negative serum or urine ß-HCG pregnancy test at screening and
all through the study
· Male must use contraception
· Voluntary written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
· Non-secretory Multiple myeloma
· Platelet count < 40,000 X 109/L
· Absolute neutrophil count <1.0 X 109/L
· Creatinine clearance <30 mL/minute
· Peripheral neuropaty >= Grade 2
· Seropositive for HIV, or active hepatitis A, B or C infection
· Pregnant or breastfeeding female
· Patient has hypersensitivity to bortezomib, boron or mannitol
· Other investigational drugs
· Serious medical or psychiatric illness
· Previous or concurrent malignancies at other sites
· Poorly controlled hypertension, uncontrolled or severe cardiovascular
disease or uncontrolled diabetes mellitus
•Concurrent cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, in particular pericarditis, or cardiac amyloidosis.
• Concurrent significant pulmonary disease, in particular interstitial pneumonia
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Male or female subjects, 18 years-of-age or older, with multiple myeloma who received at least one autologous transplantation and who have responded and later progressed or relapsed at least one year after transplantation
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Intervention(s)
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Product Name: VELCADE 3.5 mg powder for solution for injection
Product Code: PS-341, 26866138-AAA-PB-001
Pharmaceutical Form: Powder and solvent for solution for injection
Product Name: Thalidomide Pharmion
Product Code: Thalidomide Pharmion
Pharmaceutical Form: Capsule, hard
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Primary Outcome(s)
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Secondary Objective: · Response rate (complete + partial + minimal) using standard criteria
· Overall survival
· Side effects
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Primary end point(s): The main endpoint is time-to-failure (TTP=time to progression). The power is based on an initial assumption of a median TTP of 1.5 years in the experimental (Velcade) group and 1 year in the control group.
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Main Objective: Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression (TTP) than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation
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Secondary ID(s)
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NCT00256776
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2005-001628-35-BE
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X05140
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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Results
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Results available:
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