🔎 Trials Near Me

Home › Multiple Myeloma › NCT05552222

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

RecruitingPhase 3

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 1,590 · Started: Oct 25, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05552222

Locations in the U.S.

ArizonaBanner MD Anderson Cancer Center, Gilbert
University of Arizona Cancer Center, Tucson
CaliforniaUCSF Fresno, Clovis
City of Hope Duarte, Duarte
City of Hope Orange County Lennar Foundation Cancer Center, Irvine
Cancer and Blood Specialty Clinic, Los Alamitos
Valkyrie Clinical Trials, Los Angeles
ConnecticutUniversity of Connecticut, Farmington
Yale New Haven Hospital, New Haven
DelawareChristianaCare Helen F Graham Cancer Center and Research Institute, Newark
FloridaMemorial Healthcare System, Hollywood
AdventHealth Medical Group Blood & Marrow Transplant at Orlando, Orlando
Cleveland Clinic Florida, Weston
GeorgiaCity of Hope Cancer Center, Newnan
IllinoisUniversity Of Illinois Medical Center, Chicago
Loyola University Medical Center, Maywood
IowaUniversity of Iowa Health Care, Waukee
KentuckyNorton Cancer Institute, Louisville
LouisianaLSUHSC Shreveport Feist-Weiller Cancer Center, Shreveport
MarylandJohns Hopkins University School of Medicine JHUSOM, Baltimore
Center for Cancer and Blood Disorders, Bethesda
MichiganUniversity of Michigan, Ann Arbor
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion, Detroit
Cancer And Hematology Centers of Western Michigan PC, Grand Rapids
Henry Ford Providence Novi Hospital, Novi
Henry Ford Providence Southfield CK Potluri Cancer Center, Southfield
MissouriMidAmerica Cancer Care, Kansas City
NebraskaNebraska Cancer Specialists, Omaha
University of Nebraska Medical Center, Omaha
New HampshireDartmouth Hitchcock Medical Center, Lebanon
New JerseyAstera Cancer Care, East Brunswick
New MexicoChristus St. Vincent Regional Cancer Center, Santa Fe
New YorkHematology-Oncology Associates of CNY, East Syracuse
Northwell Health Cancer Institute, Lake Success
NYU Langone Hospital Long Island, Mineola
Memorial Sloan Kettering Cancer Center, New York
Perlmutter Cancer Center at NYU Langone Health, New York
Weill Cornell Medical College, New York
North CarolinaLevine Cancer Institute, Charlotte
Novant Health, Charlotte
Durham VAMC, Durham
Novant Health Zimmer Cancer Institute, Wilmington
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem
Novant Health Forsyth Medical Center, Winston-Salem
OhioOncology Hematology Care, Cincinnati
The Christ Hospital Cancer Center, Cincinnati
University of Cincinnati, Cincinnati
Cleveland Clinic Main Campus, Cleveland
University Hospitals Cleveland Medical Center, Cleveland
OhioHealth, Columbus
The Ohio State University- James Cancer Hospital, Columbus
PennsylvaniaPenn State Milton S Hershey Medical Ctr, Hershey
Allegheny Health Network, Pittsburgh
Rhode IslandRhode Island Hospital, Providence
South CarolinaMUSC-Hollings Cancer Center, Charleston
TennesseeHenry-Joyce Cancer Clinic, Nashville
TexasUniversity of Texas Southwestern Medical Center, Dallas
Houston Methodist Hospital, Houston
Joe Arrington Cancer Research Treatment Center, Lubbock
UtahHuntsman Cancer Institute, Salt Lake City
Utah Cancer Specialists, Salt Lake City
VirginiaAlexander T. Augusta Military Medical Center, Fort Belvoir
Virginia Oncology Associates Brock Cancer Center, Norfolk
Richmond VA Medical Center, Richmond
Virginia Commonwealth University Medical Center, Richmond
WashingtonNorthWest Medical Specialties, PLLC, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.