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Looking for participantsPhase3

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT05552222

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Teclistamab (drug), Daratumumab (drug), Lenalidomide (drug), Dexamethasone (drug)
How long the study runs
Study runs about 132 months (dates as stated)
About the drug or intervention
Teclistamab — drug: Teclistamab will be administered as SC injection. · Daratumumab — drug: Daratumumab will be administered as SC injection. · Lenalidomide — drug: Lenalidomide will be administered orally. · Dexamethasone — drug: Dexamethasone will be administered either orally or intravenously (IV). · Talquetamab — drug: Talquetamab will be administered as SC injection.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,590
Started
2022-10-25
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase3 - 1,590 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust
  • • Blackpool - Blackpool Victoria Hospital
  • • Bristol - Bristol NHS Foundation Trust
  • • Cambridge - Addenbrooke's Hospital
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negative

What the study is looking for

  • ✓Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • ✓Have an activity scale (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...
  • ✓A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the...

Who cannot take part

  • ✗Had plasmapheresis within 28 days of 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
  • ✗Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
  • ✗Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone
See the full criteria
Inclusion Criteria: * 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 Criteria: * 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 plasmapheresis within 28 days of 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 * Known contraindications to the use of daratumumab or lenalidomide per local prescribing information * Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone

Where Is This Study? (9 UK sites)

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2GW, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Blackpool Victoria Hospital

Blackpool FY3 8NR, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Bristol NHS Foundation Trust

Bristol BS1 3NU, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Kent and Canterbury Hospital

Canterbury CT1 3NG, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager

ekhuft.researchandinnovation@nhs.net01227 783169

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

University College London Hospitals

London NW1 2BU, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Imperial College Healthcare

London W12 0HS, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09