Les informations présentées dans l’Outil de recherche personnalisé d’essais cliniques de Myélome Canada sont issues de la base de données des essais cliniques internationaux du site ClinicalTrials.gov, répertoriées par la U.S. National Library of Medicine. Bien que le menu soit en français, les détails des études ne sont offerts qu’en anglais.
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Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

*Les informations de l'essai contenues sur cette page ont été récupérées du site ClinicalTrials.gov. Cliquez ici pour voir cet essai sur ClinicalTrials.gov.

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Titre complet:
Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Résumé:
The purpose of this study is to assess the clinical effectiveness of all approved multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory MM (RRMM) settings in real-world clinical practice.
Description détaillée:
Non disponible
Traitements:
Groupes d'étude:
: Cohort 1
Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years
: Cohort 2
Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years
Type d'étude:
Observational
Protocole de l'étude:
Observational Model: Cohort
Time Perspective: Prospective
Statut du recrutement:
En cours
Critères d'admissibilités:
ore information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria:
    For RRMM participants who have received at least one prior line of therapy (LoT) for MM:
  • Have documented progression from a prior LoT
  • Participants who have initiated treatment with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
  • IMiDs
  • PIs
  • Combination of IMiD + PI
  • Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies) For NDMM participants receiving frontline therapy:
  • Eligible to receive frontline therapy for MM (no prior MM treatment)
  • Participants who have initiated treatment for MM with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
  • IMiDs
  • PIs
  • Combination of IMiD + PI
  • Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)
Exclusion Criteria:
  • Participants who are currently participating in a clinical trial for MM
  • Participants who are currently receiving treatment for primary cancer other than MM
  • Participants who are not willing or able to provide informed consent
  • Participants who are incarcerated
  • Participants under compulsory detention for treatment of a physical (eg, infectious) or psychiatric illness Other protocol-defined inclusion/exclusion criteria apply
Lieux / Centres:

Local Institution - 0065, Toronto, Ontario – Retiré

Local Institute, Toronto, Ontario – En cours

Local Institution - 0066, Toronto, Ontario – Complet

Local Institute, Weston, Ontario – En cours

Contacts:
Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]
Publications:
???
Date d’affichage:
2013-04-24
Date de début:
June 13, 2012
Dernière mise à jour:
2023-02-16
Nombre d'inscriptions anticipées:
2555
Date de fin prévue:
2028-09-28
Date de fin prévue de l'étude primaire:
2028-09-28
Condition:
Multiple Myeloma
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Canada
France
Germany
Italy
United Kingdom
United States
Numéro d’identification:
NCT01838512
Autres numéros d'identification de l'étude:
CA204-008
Comité de suivi des données:
No
Produit réglementé par la FDA (É-U):
Non disponible
IPD Sharing Statement :
???
Responsables de l’étude:
Sponsor
Commanditaires de l’étude:
lead_sponsor
Bristol-Myers Squibb
Industry
Collaborators:
???
Chercheurs:
Bristol-Myers Squibb Bristol-Myers Squibb
Protocol Registration and Results System:
???
Date de vérification:
2023-02-01