RECRUITING

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

Conditions

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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 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).

Official Title

A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide

Quick Facts

Study Start:2024-01-22

Study Completion:2030-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06208150

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 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 6months after the last dose of study treatment	* 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

Inclusion Criteria

Exclusion 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 6months after the last dose of study treatment

* 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

Contacts and Locations

Study Contact

CONTACT

844-434-4210

Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

Yale University School Of Medicine

New Haven, Connecticut, 06519

United States

Memorial Healthcare System

Hollywood, Florida, 33021

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Winship Cancer Institute Emory University

Atlanta, Georgia, 30322

United States

Kootenai Health

Coeur d'Alene, Idaho, 83814

United States

Mission Cancer and Blood Medical Oncology and Hematology Associates of Iowa

Des Moines, Iowa, 50309

United States

Norton Cancer Institute

Louisville, Kentucky, 40207

United States

Luminis Health Center for Cancer and Blood Disorders

Annapolis, Maryland, 21401

United States

Ascension Providence Hospital

Southfield, Michigan, 48075

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

Louis Stokes Cleveland VA Med Ctr

Cleveland, Ohio, 44106

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Oregon Health And Science University

Portland, Oregon, 97239

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-4215

United States

West Penn Hospital

Pittsburgh, Pennsylvania, 15224

United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Bon Secours Saint Francis Cancer Center

Greenville, South Carolina, 29607

United States

Houston Methodist Neal Cancer Center at Texas Medical Center

Houston, Texas, 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

University of Virginia

Charlottesville, Virginia, 22903

United States

Swedish Cancer Institute

Seattle, Washington, 98104

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 Date2024-01-22

Study Completion Date2030-06-30

Study Record Updates

Study Start Date2024-01-22

Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

Relapsed or Refractory Multiple Myeloma