Recruiting
Phase 3

Tec-DR, Tal-DR

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05552222

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Teclistamab

Daratumumab

Lenalidomide

Dexamethasone

Talquetamab

Study Details

Brief summary:

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).

Conditions

Multiple Myeloma

Study ID

NCT05552222

Start date

Oct 25, 2022

Status verified date

Aug, 2026

Completion date

Oct 28, 2033

Anticipated

Primary completion date

Apr 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1590 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)

Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.

experimental: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)

Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.

active comparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)

Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

Interventions

Teclistamab

Teclistamab will be administered as SC injection.

Daratumumab

Daratumumab will be administered as SC injection.

Lenalidomide

Lenalidomide will be administered orally.

Dexamethasone

Dexamethasone will be administered either orally or intravenously (IV).

Talquetamab

Talquetamab will be administered as SC injection.

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: From randomization to the date of disease progression or death (Up to 09 years) ]
  • 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) [ Time Frame: At Month 12 ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

UCSF Fresno

Recruiting

Clovis, California, United States, 93611

City of Hope Duarte

Recruiting

Duarte, California, United States, 91010

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

University of Connecticut

Recruiting

Farmington, Connecticut, United States, 06030

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

ChristianaCare Helen F Graham Cancer Center and Research Institute

Recruiting

Newark, Delaware, United States, 19713

Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Recruiting

Orlando, Florida, United States, 32804

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

City of Hope Cancer Center

Recruiting

Newnan, Georgia, United States, 30265

University Of Illinois Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

University of Iowa Health Care

Recruiting

Waukee, Iowa, United States, 50263

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

LSUHSC Shreveport Feist-Weiller Cancer Center

Recruiting

Shreveport, Louisiana, United States, 71103

Johns Hopkins University School of Medicine JHUSOM

Recruiting

Baltimore, Maryland, United States, 21231

Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion

Recruiting

Detroit, Michigan, United States, 48202

Cancer And Hematology Centers of Western Michigan PC

Recruiting

Grand Rapids, Michigan, United States, 49503

Henry Ford Providence Novi Hospital

Recruiting

Novi, Michigan, United States, 48374

Henry Ford Providence Southfield CK Potluri Cancer Center

Recruiting

Southfield, Michigan, United States, 48075

MidAmerica Cancer Care

Recruiting

Kansas City, Missouri, United States, 64132

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Christus St. Vincent Regional Cancer Center

Recruiting

Santa Fe, New Mexico, United States, 87505

Hematology-Oncology Associates of CNY

Recruiting

East Syracuse, New York, United States, 13057

Northwell Health Cancer Institute

Recruiting

Lake Success, New York, United States, 11042

NYU Langone Hospital Long Island

Recruiting

Mineola, New York, United States, 11500

Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Novant Health

Recruiting

Charlotte, North Carolina, United States, 28204

Durham VAMC

Recruiting

Durham, North Carolina, United States, 27705

Novant Health Zimmer Cancer Institute

Recruiting

Wilmington, North Carolina, United States, 28401

Novant Health Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

The Christ Hospital Cancer Center

Recruiting

Cincinnati, Ohio, United States, 45219

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45236

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

The Ohio State University- James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

OhioHealth

Recruiting

Columbus, Ohio, United States, 43214

Penn State Milton S Hershey Medical Ctr

Recruiting

Hershey, Pennsylvania, United States, 17033

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

MUSC-Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Henry-Joyce Cancer Clinic

Recruiting

Nashville, Tennessee, United States, 37232

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Joe Arrington Cancer Research Treatment Center

Recruiting

Lubbock, Texas, United States, 79410

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84106

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Alexander T. Augusta Military Medical Center

Recruiting

Fort Belvoir, Virginia, United States, 22060

Virginia Oncology Associates Brock Cancer Center

Recruiting

Norfolk, Virginia, United States, 23502

Richmond VA Medical Center

Recruiting

Richmond, Virginia, United States, 23249

Virginia Commonwealth University Medical Center

Recruiting

Richmond, Virginia, United States, 23298

NorthWest Medical Specialties, PLLC

Recruiting

Tacoma, Washington, United States, 98405

Lakeridge Health Oshawa

Recruiting

Oshawa, Ontario, Canada, L1G-2B9

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.