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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.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Berlin, Essen, Halle (Saale), Hamburg, Nuremberg, Tuebingen, and Wuerzburg, GermanySee the 7 sitesAlso in 24 other countries, 261 sites
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
Status
Recruiting
Phase
Phase 3
People taking part
1,590 people, planned
Started
25 Oct 2022
Expected to end
28 Oct 2033
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Teclistamab
  • Daratumumab
  • Lenalidomide
  • Dexamethasone
  • Talquetamab
Record updated
3 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Germany

Also in 24 other countries, 261 sites

  • HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyNo longer taking part
  • Universitaetsklinikum Essen (AoR)Essen, GermanyNo longer taking part
  • Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyNo longer taking part
  • University Medical Center Hamburg-EppendorfHamburg, GermanyNo longer taking part
  • Klinikum NuernbergNuremberg, GermanyNo longer taking part
  • Universitaetsklinikum Tuebingen AöRTuebingen, GermanyNo longer taking part
  • Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyNo longer taking part

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)Treatment being tested

    Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.

    Treatment: Teclistamab, Daratumumab, and Lenalidomide

  • Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)Treatment being tested

    Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.

    Treatment: Daratumumab, Lenalidomide, and Talquetamab

  • Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)Existing treatment, for comparison

    Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

    Treatment: Daratumumab, Lenalidomide, and Dexamethasone

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?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests teclistamab and talquetamab with standard drugs in newly diagnosed multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05552222, who can take part
Record updated
3 November 2026