Tests teclistamab and talquetamab with standard drugs in newly diagnosed multiple myeloma
Compares teclistamab or talquetamab with daratumumab and lenalidomide against standard treatment in myeloma.
Plain-language title generated from the registry record
Registry title: A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Key facts
- Where
- Bergamo, Bologna, Florence, Milan, Naples, Pavia, Rome, Rozzano, and Turin, ItalySee the 9 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 taken lenalidomide (also called Revlimid), a tablet medicine for myeloma?
- Which describes how well you can look after yourself?
- Have you ever had a stem cell transplant using your own cells?
Source: NCT05552222, who can take part
Where in Italy
- 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
- Careggi University HospitalFlorence, ItalyNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyNo longer taking part
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNo longer taking part
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyNo longer taking part
- Humanitas Mirasole S.p.A.Rozzano, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNo 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
- Janssen Research & Development, LLC
- Trial code
- NCT05552222EU 2023-503442-30-00
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).Read full original descriptionShow less
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Inclusion: Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria; Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment; Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment; A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment.
Exclusion: Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization; Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization; Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients; Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone; Had plasmapheresis within 28 days of randomization; Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.