Collection of Additional Data Followed the Study IFM 2013-04

March 23, 2017 updated by: Nantes University Hospital

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"

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHRU Hopital Sud
      • Angers, France, 49033
        • Chu Angers
      • Argenteuil, France, 95100
        • Centre Hospitalier Argenteuil
      • Avignon, France, 84902
        • Centre Hospitalier H.Duffaut
      • Bayonne, France, 64109
        • Centre Hospitalier de la Cote Basque
      • Besançon, France, 25030
        • CHRU De Besancon
      • Bobigny, France, 93009
        • Hopital Avicenne
      • Bordeaux, France, 33 300
        • Polyclinique Bordeaux Nord Aquitaine
      • Bourgoin Jallieu, France, 38300
        • Centre hospitalier Pierre Oudot
      • Brest, France, 29609
        • Hôpital A.Morvan
      • Caen, France, 14033
        • CHU Caen Côte de Nacre
      • Cergy-pontoise, France, 95303
        • CH René Dubos
      • Chalon/saone, France, 71321
        • Centre Hospitalier William Morey
      • Clamart, France, 92141
        • Hôpital d'Instruction des Armées PERCY
      • Clermont Ferrand, France, 63000
        • CHU d'Estaing
      • Colmar, France, 68024
        • Hopitaux Civils de Colmar
      • Corbeil-essonnes, France, 91100
        • Centre Hospitalier Sud Francilien
      • Creteil, France, 94 010
        • CHU Henri Mondor
      • Dijon, France, 21000
        • CHRU Dijon
      • Dunkerque,, France, 59 385
        • Centre Hospitalier General
      • Grenoble, France, 38043
        • CHRU - Hôpital A.Michallon
      • La Roche Sur Yon, France, 85925
        • Centre Hospitalier Départemental Vendée
      • Le Coudray, France, 28000
        • Hôpital Louis Pasteur
      • Le Mans, France, 72000
        • CH Le Mans
      • Le Mans, France, 72000
        • Centre Jean Bernard
      • Lille, France, 59020
        • Hôpital Saint Vincent de Paul
      • Lille, France, 59037
        • CHRU - Hôpital Claude Huriez
      • Limoges, France, 87042
        • CHU de LIMOGES
      • Lorient, France, 56100
        • Hôpital du Scorff
      • Lyon, France, 69008
        • Centre Léon Berard
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Meaux, France, 77104
        • Centre Hospitalier de Meaux
      • Metz, France, 57085
        • CHR Metz Thionville
      • Meulan, France, 78250
        • Centre Hospitalier intercommunale Meulan les mureaux
      • Mulhouse, France, 68100
        • Hôpital E Muller
      • Nantes, France, 44093
        • Nantes University Hospital
      • Nice, France, 06202
        • Hôpital de l'Archet 1
      • Nimes, France, 30029
        • Groupe hospitalo-universitaire Caremeau
      • PARIS cedex 12, France, 75571
        • CHU - Hôpital St-Antoine
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75651
        • Hopital Pitie-Salpetriere
      • Paris, France, 75743
        • AP-HP Hôpital Necker
      • Paris, France, 93009
        • Hopital Pitie-Salpetriere
      • Perigueux, France, 24000
        • Centre Hospitalier de Perigueux
      • Perpignan, France, 66046
        • CH Saint Jean
      • Pessac, France, 33604
        • CHRU - Hôpital du Haut Lévêque
      • Pierre bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHRU - Hôpital Jean Bernard
      • Reims, France, 51092
        • Hôpital R.Debré
      • Rennes, France, 35033
        • CHRU - Hôpital de Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Malo, France, 35400
        • Centre hospitalier st Malo
      • Saint Quentin, France, 02 321
        • Centre Hospitalier
      • St Brieuc, France, 22 027
        • Centre Hospitalier Yves Le Foll
      • St Cloud, France, 92210
        • Centre René Huguenin
      • St Priest-en-jarez, France, 42 271
        • Institut de Cancerologie de la Loire
      • Strasbourg, France, 42271
        • Hopitaux Universitaires de Strasbourg
      • Toulouse, France, 31059
        • CHRU - Hôpital Purpan
      • Tours, France, 37044
        • CHRU - Hôpital Bretonneau
      • Vandoeuvre Les Nancy, France, 54511
        • CHRU - Hôpitaux de Brabois
      • Vannes, France, 56017
        • CH Bretagne Atlantique Vannes et Auray
    • Pringy,
      • Annecy, Pringy,, France, 74374
        • Centre Hospitalier de la Région d'Annecy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

340 patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient included in the study IFM 2013-04

Description

Patients newly diagnosed with symptomatic Multiple Myeloma (MM) patient

  1. - 18 ≤ age < 66 years
  2. - Eastern Cooperative Oncology Group Performance Status of 0, 1 or 2
  3. - Patients must be eligible for Autologous Stem Cell Transplantation
  4. - Patients must have measurable disease by serum M-protein ≥ 10 g/L and/or urine M-protein ≥200mg/day

  5. - 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.

  6. - 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

  7. - 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.
  8. - Patients must be capable of giving informed consent
  9. - Patients must be affiliated with French social security system

Exclusion Criteria:

  1. - Asymptomatic Multiple myeloma
  2. - Non-secretory Multiple myeloma
  3. - Proven AL-amyloidosis
  4. - Age ≥ 66 years old
  5. - 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)
  6. - Radiation therapy in the 2 weeks preceding randomization
  7. - National Cancer Institute grade ≥ 2 peripheral neuropathy
  8. - Haemoglobin < 8g/dL
  9. - Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL
  10. - Creatinine level > 170 µmol/L or requiring dialysis.
  11. - Bilirubin, transaminases or GamaGT > 3 UNL (upper normal limit)
  12. - Positive HIV serology, evidence of active Hepatitis B and C infection
  13. - Severe active infection
  14. - Inability to comply with an anti-thrombotic treatment regimen
  15. - A personal medical history of severe psychiatric disease
  16. - Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
  17. - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
  18. - 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)
  19. - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of death
Time Frame: 6 months
To evaluate Overall and Progression-Free Survival
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2017

Primary Completion (ANTICIPATED)

July 15, 2017

Study Completion (ANTICIPATED)

July 15, 2017

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC13_0284_03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myeloma Multiple

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe