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
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).
Arms & interventions
- DrugTeclistamab
Teclistamab will be administered as SC injection.
- DrugDaratumumab
Daratumumab will be administered as SC injection.
- DrugLenalidomide
Lenalidomide will be administered orally.
- DrugDexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
- DrugTalquetamab
Talquetamab will be administered as SC injection.
Outcome measures
Primary
Progression Free Survival (PFS)
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria.
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)
12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria.
Time frame: At Month 12
Secondary
Very Good Partial Response (VGPR) or Better
Time frame: From randomization up to 09 years
Complete Response (CR) or Better
Time frame: From randomization up to 09 years
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
Time frame: From randomization up to 09 years
MRD-negative CR
Time frame: From randomization up to 09 years
Progression Free Survival on Next-line Therapy (PFS2)
Time frame: From randomization up to 09 years
Overall Survival (OS)
Time frame: From randomization to the date of death (up to 09 years)
Number of Participants with Adverse Events (AEs) by Severity
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Laboratory Parameters
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Vital Signs
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Physical Examination
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Time frame: From randomization up to 09 years
Serum Concentrations of Teclistamab and Talquetamab
Time frame: From randomization up to 09 years
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab
Time frame: From randomization up to 09 years
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Time frame: From baseline up to 9 years
Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Time frame: From baseline up to 9 years
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
Time frame: From randomization up to 09 years
Eligibility criteria
Study locations (67)
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
University of Virginia
Charlottesville, Virginia, 22903
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