RecruitingInterventionalPhase 3

64407564MMY3009: 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 Pom

NCT ID: NCT06208150Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

Summary

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).

Arms & interventions

DrugTalquetamab
Talquetamab will be administered as a SC injection.
DrugPomalidomide
Pomalidomide will be administered orally.
DrugTeclistamab
Teclistamab will be administered as a SC injection.
DrugElotuzumab
Elotuzumab will be administered intravenously.
DrugDexamethasone
Dexamethasone will be administered either orally or intravenously.
DrugBortezomib
Bortezomib will be administered as a 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.
Time frame: Up to 3 years 5 months

Secondary

Overall Response Rate (ORR)
Time frame: Up to 3 years 5 months
Complete Response (CR) or Better Rate
Time frame: Up to 3 years 5 months
Very Good Partial Response (VGPR) or Better Rate
Time frame: Up to 3 years 5 months
Minimal Residual Disease (MRD)-negative CR Rate
Time frame: Up to 3 years 5 months
Overall Survival (OS)
Time frame: Up to 3 years 5 months
Progression Free Survival on Next-line Therapy (PFS2)
Time frame: Up to 3 years 5 months
Time to Next Treatment (TTNT)
Time frame: Up to 3 years 5 months
Serum Concentration of Talquetamab and Teclistamab
Time frame: Up to 3 years 5 months
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
Time frame: Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Time frame: Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
Time frame: Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Time frame: Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
Time frame: Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
Time frame: Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
Time frame: Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
Time frame: Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
Time frame: Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
Time frame: Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
Time frame: Up to 3 years 5 months
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
Time frame: Up to 3 years 5 months
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 3 years 5 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion 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 6 months after the last dose of study treatment Exclusion Criteria: * 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

Study locations (49)

UCSF Fresno

Clovis, California, 93611

Active Not Recruiting

UCLA

Santa Monica, California, 90404

Active Not Recruiting

Yale University School Of Medicine

New Haven, Connecticut, 06519

Active Not Recruiting

Medical Oncology Hematology Consultants, PA

Newark, Delaware, 19713

Recruiting

Memorial Healthcare System

Hollywood, Florida, 33021

Active Not Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Active Not Recruiting

Winship Cancer Institute Emory University

Atlanta, Georgia, 30322

Active Not Recruiting

City of Hope Cancer Center

Newnan, Georgia, 30265

Recruiting

Kootenai Health

Coeur d'Alene, Idaho, 83814

Completed

Loyola University Medical Center

Maywood, Illinois, 60153

Active Not Recruiting

University of Iowa Health Care

Waukee, Iowa, 50263

Active Not Recruiting

Norton Cancer Institute

Louisville, Kentucky, 40207

Active Not Recruiting

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808

Recruiting

Luminis Health Center for Cancer and Blood Disorders

Annapolis, Maryland, 21401

Completed

University of Maryland School of Medicine

Baltimore, Maryland, 21201

Recruiting

The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, 21287

Active Not Recruiting

University of Michigan

Ann Arbor, Michigan, 48109

Active Not Recruiting

Henry Ford Cancer Institute

Detroit, Michigan, 48202

Recruiting

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075

Active Not Recruiting

University Of Minnesota

Minneapolis, Minnesota, 55455

Active Not Recruiting

Mayo Clinic Rochester

Rochester, Minnesota, 55905

Active Not Recruiting

Regions Hospital

Saint Paul, Minnesota, 55101

Completed

University of Nebraska

Omaha, Nebraska, 68105

Active Not Recruiting

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Active Not Recruiting

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Active Not Recruiting

Roswell Park Cancer Institute

Buffalo, New York, 14263

Completed

Weill Cornell Medical College

New York, New York, 10065

Recruiting

SUNY Upstate Medical University

Syracuse, New York, 13210

Recruiting

Duke University Medical Center

Durham, North Carolina, 27705

Active Not Recruiting

Gabrail Cancer Center

Canton, Ohio, 44718

Completed

Louis Stokes Cleveland VA Med Ctr

Cleveland, Ohio, 44106

Completed

Cleveland Clinic

Cleveland, Ohio, 44195

Active Not Recruiting

Oregon Health And Science University

Portland, Oregon, 97239

Completed

Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania, 17033

Active Not Recruiting

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107 4215

Active Not Recruiting

West Penn Hospital

Pittsburgh, Pennsylvania, 15224

Active Not Recruiting

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Completed

Medical University of South Carolina

Charleston, South Carolina, 29425-8900

Recruiting

Bon Secours Saint Francis Cancer Center

Greenville, South Carolina, 29607

Active Not Recruiting

UT Southwestern Parkland Hospital

Dallas, Texas, 75390

Completed

UT Southwestern

Dallas, Texas, 75390

Active Not Recruiting

Houston Methodist Neal Cancer Center at Texas Medical Center

Houston, Texas, 77030

Completed

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Active Not Recruiting

University of Virginia

Charlottesville, Virginia, 22903

Active Not Recruiting

Swedish Cancer Institute

Seattle, Washington, 98104

Completed

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

Active Not Recruiting

NorthWest Medical Specialties, PLLC

Tacoma, Washington, 98405

Completed

Gundersen Health System

La Crosse, Wisconsin, 54601

Recruiting

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226

Active Not Recruiting