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Clinical Trials in the UK / NCT05552222
Recruiting Phase 3

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

NCT05552222 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2022-10-25
Last updated
2026-08-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

TeclistamabDaratumumabLenalidomideDexamethasoneTalquetamab

Teclistamab: Teclistamab will be administered as SC injection.

Daratumumab: Daratumumab will be administered as SC injection.

Lenalidomide: Lenalidomide will be administered orally.

Dexamethasone: Dexamethasone will be administered either orally or intravenously (IV).

Talquetamab: Talquetamab will be administered as SC injection.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (270)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
University of Arizona Cancer Center Tucson Arizona Recruiting
UCSF Fresno Clovis California Recruiting
City of Hope Duarte Duarte California Recruiting
City of Hope Orange County Lennar Foundation Cancer Center Irvine California Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
University of Connecticut Farmington Connecticut Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
ChristianaCare Helen F Graham Cancer Center and Research Institute Newark Delaware Recruiting
Memorial Healthcare System Hollywood Florida Recruiting
AdventHealth Medical Group Blood & Marrow Transplant at Orlando Orlando Florida Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
City of Hope Cancer Center Newnan Georgia Recruiting
University Of Illinois Medical Center Chicago Illinois Recruiting
Loyola University Medical Center Maywood Illinois Recruiting
University of Iowa Health Care Waukee Iowa Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
LSUHSC Shreveport Feist-Weiller Cancer Center Shreveport Louisiana Recruiting
Johns Hopkins University School of Medicine JHUSOM Baltimore Maryland Recruiting
Center for Cancer and Blood Disorders Bethesda Maryland Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion Detroit Michigan Recruiting
Cancer And Hematology Centers of Western Michigan PC Grand Rapids Michigan Recruiting
Henry Ford Providence Novi Hospital Novi Michigan Recruiting
Henry Ford Providence Southfield CK Potluri Cancer Center Southfield Michigan Recruiting
MidAmerica Cancer Care Kansas City Missouri Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
Christus St. Vincent Regional Cancer Center Santa Fe New Mexico Recruiting
Hematology-Oncology Associates of CNY East Syracuse New York Recruiting
Northwell Health Cancer Institute Lake Success New York Recruiting
NYU Langone Hospital Long Island Mineola New York Recruiting
Perlmutter Cancer Center at NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Weill Cornell Medical College New York New York Recruiting
Levine Cancer Institute Charlotte North Carolina Recruiting
Novant Health Charlotte North Carolina Recruiting

+ 230 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05552222 on ClinicalTrials.gov ↗ ← All trials in the UK