ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Quick Facts

Study Start:2022-10-13

Study Completion:2029-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05455320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

The University of Arizona Cancer Center

Tucson, Arizona, 85719

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Norwalk Hospital-oncology

Norwalk, Connecticut, 06850

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

George Washington University

Washington, District of Columbia, 20037

United States

Memorial Healthcare System

Hollywood, Florida, 33021

United States

University of Miami Health System

Miami, Florida, 33136

United States

University Of Illinois

Chicago, Illinois, 60612

United States

University of Kansas

Westwood, Kansas, 66205

United States

Tulane University Hospital & Clinics

New Orleans, Louisiana, 70112

United States

Ochsner Health System

New Orleans, Louisiana, 70121-2429

United States

Johns Hopkins University

Baltimore, Maryland, 21205

United States

Massachusetts General

Boston, Massachusetts, 02114

United States

Boston University Medical Center

Boston, Massachusetts, 02118

United States

University of Massachusetts Medical School

Worcester, Massachusetts, 01655

United States

University of Michigan Health System

Ann Arbor, Michigan, 48109

United States

University Of Minnesota

Minneapolis, Minnesota, 55455

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Washington University School Of Medicine

Saint Louis, Missouri, 63110-1032

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

United States

NYU Langone Health

New York, New York, 10016

United States

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

University of North Carolina

Chapel Hill, North Carolina, 27599

United States

Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, 28204

United States

Novant Health

Charlotte, North Carolina, 28204

United States

Novant Health

Winston-Salem, North Carolina, 27103

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, 43210

United States

OhioHealth

Columbus, Ohio, 43214

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-4215

United States

Medical University of South Carolina

Charleston, South Carolina, 29425-8900

United States

Baptist Cancer Center

Memphis, Tennessee, 38120

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Joe Arrington Cancer Research Treatment Center

Lubbock, Texas, 79410

United States

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

University of Virginia

Charlottesville, Virginia, 22903

United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, 23298

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-13

Study Completion Date2029-06-30

Study Record Updates

Study Start Date2022-10-13

Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

Relapsed or Refractory Multiple Myeloma