NCT05623020Recrutement en cours
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Résumé
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Critères d'inclusion
• Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014) • Measurable disease based on IMWG criteria as defined by at least 1 of the following: • Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2); • Urinary M-protein excretion ≥200 mg/24 hours; • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65). • Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \<65 years with comorbidities impacting the possibility of transplant. • Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as: • Participants not considered candidates for high-dose chemotherapy and ASCT due to age or • Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT. • ECOG performance status ≤2. • Not pregnant and willing to use contraception • For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Critères d'exclusion
• Smoldering Multiple Myeloma. • Monoclonal gammopathy of undetermined significance. • Waldenströms Macroglobulinemia • Plasma cell leukemia. • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness. • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator. • For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD. • For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening. • Live attenuated vaccine administered within 4 weeks of the first dose of study intervention. • Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, États-Unis, Argentine, Australie, Belgique, Brésil, Canada, Chine, Tchéquie, Finlande, Grèce, Israël, Japon, Pays-Bas, Nouvelle-Zélande, Pologne, Porto Rico, Corée du Sud, Espagne, Taïwan, Royaume-Uni
- Promoteur
- Pfizer(Industrie)
- N° de protocole
- C1071006
- Pathologies
- Multiple Myeloma
- Interventions
- Médicament
Traitements évalués
- Elranatamab
- Daratumumab
- Lenalidomide
- Dexamethasone
- Bortezomib
Lieux · 170
- Bern, SuisseInselspital BernRecrute dans ce centre
- Winterthur, SuisseKantonsspital WinterthurRecrute dans ce centre
- Nice, FranceCentre Hospitalier Universitaire de Nice - Hôpital l'ArchetRecrute dans ce centre
- Toulouse, FranceInstitut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSERecrute dans ce centre
- Poitiers, FranceCentre Hospitalier Universitaire de PoitiersRecrute dans ce centre
- Nantes, FranceCentre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecrute dans ce centre
- Paris, FranceHôpital Saint AntoineRecrute dans ce centre
- Tours, FranceCentre Hospitalier Régional Universitaire de Tours - Hôpital BretonneauRecrute dans ce centre
- Freiburg im Breisgau, AllemagneUniversitaetsklinikum FreiburgRecrute dans ce centre
- Tübingen, AllemagneUniversitaetsklinikum TuebingenRecrute dans ce centre
- Ulm, AllemagneUniversitaetsklinikum UlmRecrute dans ce centre
- Mainz, AllemagneUniversitätsmedizin Johannes Gutenberg Universität MainzRecrute dans ce centre
- Aachen, AllemagneUniversitätsklinikum AachenRecrute dans ce centre
- Braunschweig, AllemagneStädtisches Klinikum BraunschweigRecrute dans ce centre
- Chemnitz, AllemagneKlinikum ChemnitzRecrute dans ce centre
- Hamburg, AllemagneAsklepiosklinik AltonaRecrute dans ce centre
- Meldola (Fc), ItalieIRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.lRecrute dans ce centre
- Piacenza, ItalieAUSL di PiacenzaRecrute dans ce centre
- Ravenna, ItalieOspedale Santa Maria delle CrociRecrute dans ce centre
- San Giovanni Rotondo, ItalieIRCCS Casa Sollievo della SofferenzaRecrute dans ce centre
- Aviano, ItalieCro-IrccsRecrute dans ce centre
- Monza, ItalieFondazione IRCCS San Gerardo dei TintoriRecrute dans ce centre
- Turin, ItalieAzienda Ospedaliero-Universitaria Città della Salute e della Scienza di TorinoRecrute dans ce centre
- Palermo, ItalieA.O.U. Policlinico Paolo GiacconeRecrute dans ce centre
- Pisa, ItalieAzienda Ospedaliero Universitaria PisanaRecrute dans ce centre
- Bergamo, ItalieAzienda Socio Sanitaria Territoriale Papa Giovanni XXIIIRecrute dans ce centre
- Milan, ItalieIstituto Europeo di Oncologia IRCCSRecrute dans ce centre
- Pescara, ItalieASL PESCARA-Presidio Ospedaliero PescaraRecrute dans ce centre
- Pescara, ItalieAzienda Sanitaria Locale di PescaraRecrute dans ce centre
- Roma, ItalieAOU Policlinico Umberto IRecrute dans ce centre
Au total, dans le monde, 170 des 180 centres listés au registre recrutent ; les 10 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 27 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 140 autres lieux
Autres identifiants
- MAGNETISMM-6 · autre identifiant
- 2024-514139-50-00 · autre registre
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.