NCT05243797Recruiting
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
Summary
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 criteria
• 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 criteria
• 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). • Discontinued treatment due to any AE related to lenalidomide as determined by the investigator. • 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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, Greece, Ireland, Israel, Netherlands, Norway, Poland, Portugal, Serbia, South Korea, Turkey (Türkiye), United Kingdom
- Sponsor
- European Myeloma Network B.V.(Network / cooperative)
- Protocol no.
- EMN30/64007957MMY3003
- Conditions
- Multiple Myeloma
- Interventions
- Drug
Treatments studied
- Teclistamab
- Lenalidomide
Collaborators
Janssen Pharmaceutica
Locations · 199
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
- Bern, SwitzerlandInselspitalRecruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Bordeaux, FranceCentre Hospitalier Universitaire De BordeauxRecruiting at this site
- Lille, FranceDepartment of Hematology, CHU LilleRecruiting at this site
- Marseille, FranceInstitut Paoli CalmettesRecruiting at this site
- Montpellier, FranceCentre Hospitalier Universitaire De MontpellierRecruiting at this site
- Nantes, FranceCentre Hospitalier Universitaire De NantesRecruiting at this site
- Paris, FranceHopital Saint LouisRecruiting at this site
- Paris, FranceHôpital Saint-AntoineRecruiting at this site
- Poitiers, FranceCentre Hospitalier Universitaire De PoitiersRecruiting at this site
- Toulouse, FranceCentre Hospitalier Universitaire De ToulouseRecruiting at this site
- Hamburg, GermanyUniversitätsklinikum Hamburg - EppendorfRecruiting at this site
- Heidelberg, GermanyUniversitaetsklinikum Heidelberg AöRRecruiting at this site
- Jena, GermanyUniversitaetsklinikum Jena KöRRecruiting at this site
- München, GermanyKlinikum rechts der Isar der TU Muenchen AöRRecruiting at this site
- Nuremberg, GermanyKlinikum NuernbergRecruiting at this site
- Tübingen, GermanyUniversitaetsklinikum Tuebingen AöRRecruiting at this site
- Würzburg, GermanyUniversity Hospital of WürzburgRecruiting at this site
- Alessandria, ItalyAzienda Sanitaria Locale Al Di AlessandriaRecruiting at this site
- Ancona, ItalyAzienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiRecruiting at this site
- Bari, ItalyAOU G. BaccelliRecruiting at this site
- Bari, ItalyAOU Policlinico di BariRecruiting at this site
- Bergamo, ItalyASST Papa Giovanni XXIII HospitalRecruiting at this site
- Bologna, ItalyA.O.U. di Bologna - Policlinico S. Orsola MalpighiRecruiting at this site
- Brescia, ItalyA.O.Spedali Civili di BresciaRecruiting at this site
- Cagliari, ItalyOspedale Oncologico 'A. Businco'Recruiting at this site
- Cosenza, ItalyAzienda Ospedaliera-Universitaria Di CosenzaRecruiting at this site
- Florence, ItalyCareggi University HospitalRecruiting at this site
- Genova, ItalyIRCCS Ospedale Policlinico San MartinoRecruiting at this site
In total, worldwide, 199 of the 212 sites listed in the registry are recruiting; the other 13 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 7, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 169 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.