Dysautonomia International

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

Purpose

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).

Condition

Multiple Myeloma

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts 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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)	Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.	Drug: Teclistamab Teclistamab will be administered as SC injection. Other names: JNJ-64007957 Drug: Daratumumab Daratumumab will be administered as SC injection. Drug: Lenalidomide Lenalidomide will be administered orally.
Experimental Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)	Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.	Drug: Daratumumab Daratumumab will be administered as SC injection. Drug: Lenalidomide Lenalidomide will be administered orally. Drug: Talquetamab Talquetamab will be administered as SC injection. Other names: JNJ-64407564
Active Comparator Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)	Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.	Drug: Daratumumab Daratumumab will be administered as SC injection. Drug: Lenalidomide Lenalidomide will be administered orally. Drug: Dexamethasone Dexamethasone will be administered either orally or intravenously (IV).

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234

University of Arizona Cancer Center
Tucson, Arizona 85719

UCSF Fresno
Clovis, California 93611

City of Hope Duarte
Duarte, California 91010

City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 92618

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

Valkyrie Clinical Trials
Los Angeles, California 90067

University of Connecticut
Farmington, Connecticut 06030

Yale New Haven Hospital
New Haven, Connecticut 06510

ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware 19713

Memorial Healthcare System
Hollywood, Florida 33021

AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida 32804

Cleveland Clinic Florida
Weston, Florida 33331

City of Hope Cancer Center
Newnan, Georgia 30265

University Of Illinois Medical Center
Chicago, Illinois 60612

Loyola University Medical Center
Maywood, Illinois 60153

University of Iowa Health Care
Waukee, Iowa 50263

Norton Cancer Institute
Louisville, Kentucky 40207

LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport, Louisiana 71103

Johns Hopkins University School of Medicine JHUSOM
Baltimore, Maryland 21231

Center for Cancer and Blood Disorders
Bethesda, Maryland 20817

University of Michigan
Ann Arbor, Michigan 48109

Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
Detroit, Michigan 48202

Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan 49503

Henry Ford Providence Novi Hospital
Novi, Michigan 48374

Henry Ford Providence Southfield CK Potluri Cancer Center
Southfield, Michigan 48075

MidAmerica Cancer Care
Kansas City, Missouri 64132

Nebraska Cancer Specialists
Omaha, Nebraska 68130

University of Nebraska Medical Center
Omaha, Nebraska 68198

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

Astera Cancer Care
East Brunswick, New Jersey 08816

Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico 87505

Hematology-Oncology Associates of CNY
East Syracuse, New York 13057

Northwell Health Cancer Institute
Lake Success, New York 11042

NYU Langone Hospital Long Island
Mineola, New York 11500

Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Weill Cornell Medical College
New York, New York 10065

Levine Cancer Institute
Charlotte, North Carolina 28204

Novant Health
Charlotte, North Carolina 28204

Durham VAMC
Durham, North Carolina 27705

Novant Health Zimmer Cancer Institute
Wilmington, North Carolina 28401

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103

Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157

The Christ Hospital Cancer Center
Cincinnati, Ohio 45219

Oncology Hematology Care
Cincinnati, Ohio 45236

University of Cincinnati
Cincinnati, Ohio 45267

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Cleveland Clinic Main Campus
Cleveland, Ohio 44195

The Ohio State University- James Cancer Hospital
Columbus, Ohio 43210

OhioHealth
Columbus, Ohio 43214

Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania 17033

Allegheny Health Network
Pittsburgh, Pennsylvania 15224

Rhode Island Hospital
Providence, Rhode Island 02903

MUSC-Hollings Cancer Center
Charleston, South Carolina 29425

Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232

University of Texas Southwestern Medical Center
Dallas, Texas 75235

Houston Methodist Hospital
Houston, Texas 77030

Joe Arrington Cancer Research Treatment Center
Lubbock, Texas 79410

Utah Cancer Specialists
Salt Lake City, Utah 84106

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia 22060

Virginia Oncology Associates Brock Cancer Center
Norfolk, Virginia 23502

Richmond VA Medical Center
Richmond, Virginia 23249

Virginia Commonwealth University Medical Center
Richmond, Virginia 23298

NorthWest Medical Specialties, PLLC
Tacoma, Washington 98405

More Details

Status: Recruiting
Sponsor: Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.