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Collection of Additional Data Followed the Study IFM 2013-04

Sponsor
Nantes University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03089411
Collaborator
(none)
340
Enrollment
63
Locations
3.8
Anticipated Duration (Months)
5.4
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    340 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Collection of Additional Data Followed the Study "A Phase III Study of Velcade (Bortezomib) Thalidomide Dexaméthasone (VTD) Versus Velcade (Bortezomib) Cyclophosphamide Dexaméthasone (VCD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma"
    Actual Study Start Date :
    Mar 20, 2017
    Anticipated Primary Completion Date :
    Jul 15, 2017
    Anticipated Study Completion Date :
    Jul 15, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Number of death [6 months]

      To evaluate Overall and Progression-Free Survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 66 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient

      • 18 ≤ age < 66 years
      • Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2
      • Patients must be eligible for Autologous Stem Cell Transplantation
      • Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day
      • Female patients of child-bearing potential (FCBP):

    • Must agree to have medically supervised pregnancy tests prior to starting study and every 21 days, including 4 weeks after the end of study treatment. This applies even if the patient practices complete and continued sexual abstinence.

    • Must agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.

      • Male Patients:

    • Must agree to use a condom during sexual contact with a FCBP, throughout study drug therapy, during any dose interruption and for one week after discontinuation of study therapy

    • Must agree to not donate semen during study drug therapy and for one week after discontinuation of study therapy

      • All patients must:

    • Agree to abstain from donating blood while taking study drug therapy and for one week after discontinuation of study drug therapy

    • Agree not to share study medication with another person.

      • Patients must be capable of giving informed consent
      • Patients must be affiliated with French social security system
    Exclusion Criteria:
      • Asymptomatic Multiple myeloma
      • Non-secretory Multiple myeloma
      • Proven AL-amyloidosis
      • Age ≥ 66 years old
      • Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg)
      • Radiation therapy in the 2 weeks preceding randomization
      • National Cancer Institute grade ≥ 2 peripheral neuropathy
      • Haemoglobin < 8g/dL
      • Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL
      • Creatinine level > 170 µmol/L or requiring dialysis.
      • Bilirubin, transaminases or GamaGT > 3 UNL (upper normal limit)
      • Positive HIV serology, evidence of active Hepatitis B and C infection
      • Severe active infection
      • Inability to comply with an anti-thrombotic treatment regimen
      • A personal medical history of severe psychiatric disease
      • Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
      • Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
      • A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation > or = 5 years (except for basocellular skin cancer or in situ cervical cancer)
      • Use of any investigational drug in the 30 days preceding randomization 22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier de la région d'Annecy Annecy Pringy, France 74374
    2 CHRU Hôpital Sud Amiens France 80054
    3 CHU Angers Angers France 49033
    4 Centre Hospitalier Argenteuil Argenteuil France 95100
    5 Centre Hospitalier H.Duffaut Avignon France 84902
    6 Centre Hospitalier de la Côte Basque Bayonne France 64109
    7 CHRU de Besançon Besançon France 25030
    8 Hôpital Avicenne Bobigny France 93009
    9 Polyclinique Bordeaux Nord Aquitaine Bordeaux France 33 300
    10 Centre hospitalier Pierre Oudot Bourgoin Jallieu France 38300
    11 Hôpital A.Morvan Brest France 29609
    12 CHU Caen Côte de Nacre Caen France 14033
    13 CH René Dubos Cergy-pontoise France 95303
    14 Centre Hospitalier William Morey Chalon/saone France 71321
    15 Hôpital d'instruction des armées Percy Clamart France 92141
    16 CHU d'Estaing Clermont Ferrand France 63000
    17 Hôpitaux civils de Colmar Colmar France 68024
    18 Centre Hospitalier Sud Francilien Corbeil-essonnes France 91100
    19 CHU Henri Mondor Creteil France 94 010
    20 CHRU Dijon Dijon France 21000
    21 Centre Hospitalier Général Dunkerque, France 59 385
    22 CHRU - Hôpital A.Michallon Grenoble France 38043
    23 Centre hospitalier départemental Vendée La Roche Sur Yon France 85925
    24 Hôpital Louis Pasteur Le Coudray France 28000
    25 Centre Jean Bernard Le Mans France 72000
    26 CH Le Mans Le Mans France 72000
    27 Hopital Saint Vincent de Paul Lille France 59020
    28 CHRU - Hôpital Claude Huriez Lille France 59037
    29 CHU de Limoges Limoges France 87042
    30 Hôpital Du Scorff Lorient France 56100
    31 Centre Léon Bérard Lyon France 69008
    32 Institut Paoli Calmettes Marseille France 13273
    33 Centre Hospitalier de Meaux Meaux France 77104
    34 CHR Metz Thionville Metz France 57085
    35 Centre Hospitalier intercommunale Meulan les mureaux Meulan France 78250
    36 Hopital E Muller Mulhouse France 68100
    37 Nantes University Hospital Nantes France 44093
    38 Hôpital de l'Archet 1 Nice France 06202
    39 Groupe Hospitalo-Universitaire Carémeau Nimes France 30029
    40 CHU - Hôpital St-Antoine PARIS cedex 12 France 75571
    41 Institut CURIE Paris France 75005
    42 Hôpital Cochin Paris France 75014
    43 Hôpital Pitié-Salpétrière Paris France 75651
    44 AP-HP Hôpital Necker Paris France 75743
    45 Hôpital Pitié-Salpétrière Paris France 93009
    46 Centre Hospitalier de PERIGUEUX Perigueux France 24000
    47 CH Saint Jean Perpignan France 66046
    48 CHRU - Hôpital du Haut Lévêque Pessac France 33604
    49 Centre Hospitalier Lyon sud Pierre bénite France 69495
    50 CHRU - Hôpital Jean Bernard Poitiers France 86021
    51 Hôpital R.Debré Reims France 51092
    52 CHRU - Hôpital de Pontchaillou Rennes France 35033
    53 Centre Henri Becquerel Rouen France 76038
    54 Centre hospitalier st Malo Saint Malo France 35400
    55 Centre Hospitalier Saint Quentin France 02 321
    56 Centre Hospitalier Yves le Foll St Brieuc France 22 027
    57 Centre René Huguenin St Cloud France 92210
    58 Institut de Cancérologie de la Loire St Priest-en-jarez France 42 271
    59 Hôpitaux Universitaires de Strasbourg Strasbourg France 42271
    60 CHRU - Hôpital Purpan Toulouse France 31059
    61 CHRU - Hôpital Bretonneau Tours France 37044
    62 CHRU - Hôpitaux de Brabois Vandoeuvre Les Nancy France 54511
    63 CH Bretagne Atlantique Vannes et Auray Vannes France 56017

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT03089411
    Other Study ID Numbers:
    • RC13_0284_03
    First Posted:
    Mar 24, 2017
    Last Update Posted:
    Mar 27, 2017
    Last Verified:
    Mar 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nantes University Hospital
    myeloma multiple
    newly diagnosed
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Mar 27, 2017