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Taking peoplePhase 3

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
Badalona, Barcelona, Granada, Jerez de la Frontera, L'Hospitalet de Llobregat, Madrid, Palma, Pozuelo de Alarcón, Salamanca, Terrassa, and Valencia, SpainSee the 14 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed multiple myeloma who cannot have, or will not have at first, a high-dose chemotherapy with their own stem cells (autologous stem cell transplant).

Age
18 years or older
Sex
All sexes can join
Disease stage
Newly diagnosed multiple myeloma; not a candidate for high-dose chemotherapy with autologous stem cell transplant (because of advanced age, other health conditions, or the transplant being put off); ECOG performance status 0 to 2
Earlier treatment
Must not have had any earlier treatment for multiple myeloma or smoldering myeloma, except a short course of corticosteroids (no more than 160 mg dexamethasone or equivalent in total)

Main reasons for not taking part

  • Any earlier treatment for multiple myeloma or smoldering myeloma, other than a short course of corticosteroids
  • Plasmapheresis within 28 days before randomization
  • Stroke, transient ischemic attack, or seizure within 6 months before randomization
  • Known allergy or intolerance to teclistamab or talquetamab excipients
  • Known contraindications to daratumumab or lenalidomide

Read by machine on 9 November 2026.

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 Spain

  • Institut Catala d'OncologiaBadalona, SpainNo longer taking part
  • Hospital de la Santa Creu i Sant PauBarcelona, SpainNo longer taking part
  • Hospital Universitari Vall d'HebronBarcelona, SpainNo longer taking part
  • Hospital Universitario Virgen de las NievesGranada, SpainNo longer taking part
  • Hospital de Jerez de la FronteraJerez de la Frontera, SpainNo longer taking part
  • Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainNo longer taking part
  • Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
  • Hospital Universitario HM SanchinarroMadrid, SpainNo longer taking part
  • Hospital Universitario La PazMadrid, SpainNo longer taking part
  • University Hospital Son EspasesPalma, SpainNo longer taking part
  • Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainNo longer taking part
  • Hospital Universitario De SalamancaSalamanca, SpainNo longer taking part
  • Fundacio Assistencial De Mutua De Terrassa FpcTerrassa, SpainNo longer taking part
  • Hospital Clinico Universitario de ValenciaValencia, SpainNo 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
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.

ClinicalTrials.gov NCT05552222 · EU CTIS 2023-503442-30-00