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NCT05160584Recrutement en cours

A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

Résumé

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Critères d'inclusion

• For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date • For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2 • For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period • For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection • For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy • For Period 1 and 2: Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible • For Period 1 and 2: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio • Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens) • Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens) • For period 3: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) or urine M-protein level \>= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain \>= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (\>=1 lesion has 2 diameters \>= 1 centimeter \[cm\])

Critères d'exclusion

Contacts

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

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Statut
Recrutement en cours
Phase
—
Type d'étude
Observationnelle
Pays
Suisse, France, Allemagne, Italie, Autriche, Belgique, Grèce, Pays-Bas, Portugal, Roumanie, Espagne, Royaume-Uni
Promoteur
Janssen Pharmaceutica N.V., Belgium(Industrie)
N° de protocole
CR109118
Pathologies
Relapsed/Refractory Multiple Myeloma
Interventions
Autre

Traitements évalués

  • No intervention

Lieux · 47

  • Chur, SuisseKantonsspital GraubundenRecrute dans ce centre
  • Winterthur, SuisseKantonsspital Winterthur, Medizinische OnkologieRecrute dans ce centre
  • Zurich, SuisseHirslanden Klinik HirslandenRecrute dans ce centre
  • Zurich, SuisseUniversitatsspital ZurichRecrute dans ce centre
  • Bari, ItalieU.O. Ematologia Istituto Tumori Giovanni Paolo IIRecrute dans ce centre
  • Bologna, ItalieIstituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-MalpighiRecrute dans ce centre
  • Civitanova Marche, ItalieOspedale Civile di Civitanova MarcheRecrute dans ce centre
  • Genova, ItalieOspedale Policlinico San Martino IRCCSRecrute dans ce centre
  • Lecce, ItalieOspedale Vito FazziRecrute dans ce centre
  • Palermo, ItalieOspedale Villa Sofia-CervelloRecrute dans ce centre
  • Pavia, ItalieFondazione IRCCS Policlinico San MatteoRecrute dans ce centre
  • Pescara, ItaliePresidio Ospedaliero PescaraRecrute dans ce centre
  • Reggio Calabria, ItalieGrande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio CalabriaRecrute dans ce centre
  • Roma, ItalieFondazione Policlinico Universitario A Gemelli IRCCSRecrute dans ce centre
  • Roma, ItalieCampus Bio Medico di RomaRecrute dans ce centre
  • San Giovanni Rotondo, ItalieCasa Sollievo Della Sofferenza IRCCSRecrute dans ce centre
  • Vicenza, ItalieAzienda Ulss 8 Berica- Ospedale Di VicenzaRecrute dans ce centre
  • Leoben, AutricheLKH LeobenRecrute dans ce centre
  • Vienna, AutricheKrankenhaus der barmherzigen SchwesternRecrute dans ce centre
  • Edegem, BelgiqueUZ AntwerpenRecrute dans ce centre
  • Genk, BelgiqueZiekenhuis Oost-LimburgRecrute dans ce centre
  • Mons, BelgiqueChu Helora Hospital De Mons Site KennedyRecrute dans ce centre
  • Sint-Niklaas, BelgiqueVitazRecrute dans ce centre
  • Alexandroupoli, GrèceUniversity Hospital of AlexandroupolisRecrute dans ce centre
  • Athens, GrèceHenry Dunant Hospital CenterRecrute dans ce centre
  • Athens, GrèceLaiko General Hospital Of Athens 1Recrute dans ce centre
  • Athens, GrèceLaiko General Hospital of Athens 2Recrute dans ce centre
  • Athens, GrèceAlexandra HospitalRecrute dans ce centre
  • Piraeus, GrèceMetaxa Cancer Center Hospital Of PiraeusRecrute dans ce centre
  • Rio, GrèceGeneral University Hospital of PatrasRecrute dans ce centre

Au total, dans le monde, 47 des 90 centres listés au registre recrutent ; les 43 autres ne recrutent pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 25 septembre 2026).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

+ 17 autres lieux

Autres identifiants

  • 64407564MMY4001 · autre identifiant

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Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.