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Clinical Trials in the USA / NCT05455320
Active, not recruiting Phase 3

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

NCT05455320 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2022-10-13
Last updated
2026-08-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Talquetamab →Daratumumab →Pomalidomide →Dexamethasone →

Talquetamab: Talquetamab will be administered subcutaneously.

Daratumumab: Daratumumab will be administered subcutaneously.

Pomalidomide: Pomalidomide will be administered orally.

Dexamethasone: Dexamethasone will be administered orally or intravenously.

Study summary

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level \>= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain \>= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio * Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (\>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (\<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment * Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received \>=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed * Documented evidence of progressive disease based on investigator's determination of response by the 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 Exclusion Criteria: * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients * Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) * Received prior pomalidomide therapy * A maximum cumulative dose of corticosteroids to \>=140 milligrams (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 * Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Primary outcome measure(s)

Trial sites (216)

FacilityCityRegionStatus
The University of Arizona Cancer Center Tucson Arizona
University of Arkansas for Medical Sciences Little Rock Arkansas
Norwalk Hospital-oncology Norwalk Connecticut
MedStar Georgetown University Hospital Washington D.C. District of Columbia
George Washington University Washington D.C. District of Columbia
Memorial Healthcare System Hollywood Florida
University of Miami Health System Miami Florida
University Of Illinois Chicago Illinois
University of Kansas Westwood Kansas
Tulane University Hospital & Clinics New Orleans Louisiana
Ochsner Health System New Orleans Louisiana
Johns Hopkins University Baltimore Maryland
Massachusetts General Boston Massachusetts
Boston University Medical Center Boston Massachusetts
University of Massachusetts Medical School Worcester Massachusetts
University of Michigan Health System Ann Arbor Michigan
University Of Minnesota Minneapolis Minnesota
University of Mississippi Medical Center Jackson Mississippi
Washington University School Of Medicine St Louis Missouri
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
NYU Langone Health New York New York
SUNY Upstate Medical University Syracuse New York
University of North Carolina Chapel Hill North Carolina
Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina
Novant Health 1 Charlotte North Carolina
Novant Health Winston-Salem North Carolina
Wake Forest Baptist Medical Center Winston-Salem North Carolina
University Hospitals Cleveland Medical Center Cleveland Ohio
The Ohio State University Wexner Medical Center - James Cancer Hospital Columbus Ohio
OhioHealth Columbus Ohio
Thomas Jefferson University Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
Baptist Cancer Center Memphis Tennessee
Houston Methodist Hospital Houston Texas
MD Anderson Cancer Center Houston Texas
Joe Arrington Cancer Research Treatment Center Lubbock Texas
Huntsman Cancer Institute Salt Lake City Utah
University of Virginia Charlottesville Virginia
Virginia Commonwealth University - Massey Cancer Center Richmond Virginia
Fred Hutchinson Cancer Research Center Seattle Washington

+ 176 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile →

More Janssen Research & Development, LLC trials in the USA

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 NCT05455320 on ClinicalTrials.gov ↗ ← All trials in the USA