Teclistamab With or Without Lenalidomide for Newly Diagnosed Multiple Myeloma
Tests teclistamab, alone or with lenalidomide, in adults with newly diagnosed multiple myeloma.
Plain-language title generated from the registry record
Registry title: 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
- Ankara, Istanbul, Izmir, and Kayseri, TürkiyeSee the 7 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 Türkiye
- Ankara Liv HospitalAnkara, TürkiyeNo longer taking part
- Ankara University HospitalAnkara, TürkiyeNo longer taking part
- Florence Nightingale HospitalIstanbul, TürkiyeNo longer taking part
- Memorial Sisli Hospital, Dept of HematologyIstanbul, TürkiyeNo longer taking part
- Ege University Medical faculty Hospital Internal Medicine Department Adult Hematology UnitIzmir, TürkiyeNo longer taking part
- Izmir Economy University Medical Point HospitalIzmir, TürkiyeNo longer taking part
- Erciyes University HospitalKayseri, TürkiyeNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.