Clinical Trial Page

Summary
EudraCT Number:2006-005462-40
Sponsor's Protocol Code Number:0603603
National Competent Authority:France - ANSM
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2007-01-19
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedFrance - ANSM
A.2EudraCT number2006-005462-40
A.3Full title of the trial
Association du Velcade au Melphalan dans le conditionnement à l'autogreffe de celulles souches hématopoïétiques des patients de moins de 65 ans atteints de myélome. Etude pilote de l'Intergroupe Francophone du Myélome.
A.4.1Sponsor's protocol code number0603603
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorCHU Toulouse
B.1.3.4CountryFrance
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name VELCADE
D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG
D.2.1.2Country which granted the Marketing AuthorisationFrance
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Powder for solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
myeloma
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10028566
E.1.2Term Myeloma
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Evaluer le taux de Réponse Complète et de très bonne réponse partielle (VGPR) 3 mois après autogreffe de cellules souches périphériques conditionnée par Velcade-Melphalan.
E.2.2Secondary objectives of the trial
-Apprécier la toxicité du conditionnement par Velcade-Melphalan (toxicité hématologique et viscérale suivant les critères NCI version 3) dans les 3ers mois.
-Apprécier la survie sans événement après la greffe
-Apprécier la survie globale après la greffe
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Bon état général (code OMS ≤ 2 ; annexe 2).
- Créatinine ≤ 250 µmol/L.
- Greffon de bonne qualité en fonction des normes de chaque centre (à titre indicatif ≥ 5 X 106 CD34/Kg).
- Consentement éclairé et écrit du patient.
- Patient affilié à un régime de sécurité sociale.
- Absence tout autre critère d'exclusion (cf. IV.3.)
- Absence de maladie progressive avant la greffe. Les patients en réponse (complète, partielle, ou minime) ou en maladie stable pourront être inclus.
E.4Principal exclusion criteria
- Refus du patient de participer à l’étude.
- Patient placé sous sauvegarde de justice ou sous tutelle/curatelle
- Femme enceinte ou allaitante ou en âge de procréer sans contraception efficace
- Hypersensibilité au Bortézomib ou bore ou à l’un des excipients
- Insuffisance hépatique sévère
E.5 End points
E.5.1Primary end point(s)
Evaluation de la réponse à 3 mois de l’intensification selon les critères uniformisés de l’International Myeloma Working Group publiés en Juillet 2006 (Leukemia 2006 : 20, 1467–1473)
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety No
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised Information not present in EudraCT
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned35
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
Dernière visite du dernier patient
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years4
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state61
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2007-03-26
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2007-02-02
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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