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Active, not recruitingPhase 3

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Key facts

Where
Alexandria, Ancona, Bari, Bergamo, Bologna, Brescia, Cagliari, Cosenza, Florence, Genoa, Milan, Modena, Naples, Novara, Padova, Parma, Pavia, Pescara, Ravenna, Reggio Emilia, Rimini, Rome, San Giovanni Rotondo, Trieste, Turin, and Udine, ItalySee the 27 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which of these best describes your myeloma treatment so far?
  • Have you ever had a stem cell transplant using your own cells?

Source: NCT05243797, who can take part

Where in Italy

  • Azienda Sanitaria Locale Al Di AlessandriaAlexandria, ItalyNo longer taking part
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, ItalyNo longer taking part
  • University Of Bari Aldo MoroBari, ItalyNo longer taking part
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNo longer taking part
  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNo longer taking part
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyNo longer taking part
  • ARNAS G. BrotzuCagliari, ItalyNo longer taking part
  • Azienda Ospedaliera-Universitaria Di CosenzaCosenza, ItalyNo longer taking part
  • Careggi University HospitalFlorence, ItalyNo longer taking part
  • IRCCS Ospedale Policlinico San MartinoGenoa, ItalyNo longer taking part
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNo longer taking part
  • Azienda Ospedaliero - Universitaria di ModenaModena, ItalyNo longer taking part
  • Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyNo longer taking part
  • Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyNo longer taking part
  • Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyNo longer taking part
  • Azienda Ospedaliera di PadovaPadova, ItalyNo longer taking part
  • University Hospitals Parma Medical CenterParma, ItalyNo longer taking part
  • Fondazione IRCCS Policlinico San MatteoPavia, ItalyNo longer taking part
  • Azienda Sanitaria Locale di PescaraPescara, ItalyNo longer taking part
  • Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyNo longer taking part
  • Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyNo longer taking part
  • Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyNo longer taking part
  • Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyNo longer taking part
  • Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyNo longer taking part
  • Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyNo longer taking part
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNo longer taking part
  • Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
European Myeloma Network B.V.
Trial code
NCT05243797EU 2023-510384-36-00
Record updated
10 November 2026
Original description
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.Read full original descriptionShow less

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Inclusion: Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation; Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose; Must not be intolerant to the starting dose of lenalidomide; Must not have received any maintenance therapy; Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment; Have clinical laboratory values within prespecified range.

Exclusion: Received any prior BCMA-directed therapy; Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells); Progressed on multiple myeloma therapy at any time prior to screening; Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose; Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed; Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.

ClinicalTrials.gov NCT05243797 · EU CTIS 2023-510384-36-00