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Clinical Trials in the UK / NCT06208150
Active, not recruiting Phase 3

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

NCT06208150 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-01-22
Last updated
2026-08-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

TalquetamabPomalidomideTeclistamabElotuzumabDexamethasoneBortezomib

Talquetamab: Talquetamab will be administered as a SC injection.

Pomalidomide: Pomalidomide will be administered orally.

Teclistamab: Teclistamab will be administered as a SC injection.

Elotuzumab: Elotuzumab will be administered intravenously.

Dexamethasone: Dexamethasone will be administered either orally or intravenously.

Bortezomib: Bortezomib will be administered as a SC injection.

Study summary

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level \>= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (\>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (\<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment * Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment * 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 Exclusion Criteria: * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients * Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF) * Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment * A maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug * Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Primary outcome measure(s)

Trial sites (242)

FacilityCityRegionStatus
UCSF Fresno Clovis California
UCLA Santa Monica California
Yale University School Of Medicine New Haven Connecticut
Medical Oncology Hematology Consultants, PA Newark Delaware
Memorial Healthcare System Hollywood Florida
Moffitt Cancer Center Tampa Florida
Winship Cancer Institute Emory University Atlanta Georgia
City of Hope Cancer Center Newnan Georgia
Kootenai Health Coeur d'Alene Idaho
Loyola University Medical Center Maywood Illinois
University of Iowa Health Care Waukee Iowa
Norton Cancer Institute Louisville Kentucky
Our Lady of the Lake Hospital Baton Rouge Louisiana
Luminis Health Center for Cancer and Blood Disorders Annapolis Maryland
University of Maryland School of Medicine Baltimore Maryland
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins Baltimore Maryland
University of Michigan Ann Arbor Michigan
Henry Ford Cancer Institute Detroit Michigan
Henry Ford Health Providence Southfield Hospital Southfield Michigan
University Of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Rochester Minnesota
Regions Hospital Saint Paul Minnesota
University of Nebraska Omaha Nebraska
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
Roswell Park Cancer Institute Buffalo New York
Weill Cornell Medical College New York New York
SUNY Upstate Medical University Syracuse New York
Duke University Medical Center Durham North Carolina
Gabrail Cancer Center Canton Ohio
Louis Stokes Cleveland VA Med Ctr Cleveland Ohio
Cleveland Clinic Cleveland Ohio
Oregon Health And Science University Portland Oregon
Penn State Milton S Hershey Medical Ctr Hershey Pennsylvania
Thomas Jefferson University Philadelphia Pennsylvania
West Penn Hospital Pittsburgh Pennsylvania
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Bon Secours Saint Francis Cancer Center Greenville South Carolina
UT Southwestern Parkland Hospital Dallas Texas

+ 202 more sites — see the full list on the official registry below.

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 NCT06208150 on ClinicalTrials.gov ↗ ← All trials in the UK