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Purpose

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio - Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment - Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed - Documented evidence of progressive disease based on investigator's determination of response by the 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

Exclusion Criteria

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients - Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) - Received prior pomalidomide therapy - A maximum cumulative dose of corticosteroids to >=140 milligrams (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 - Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP) 		Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other names:
    • JNJ-64407564
  • Drug: Daratumumab
    Daratumumab will be administered subcutaneously.
  • Drug: Pomalidomide
    Pomalidomide will be administered orally.
  • Drug: Dexamethasone
    Dexamethasone will be administered orally or intravenously.
Experimental
Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd) 		Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Drug: Daratumumab
    Daratumumab will be administered subcutaneously.
  • Drug: Pomalidomide
    Pomalidomide will be administered orally.
  • Drug: Dexamethasone
    Dexamethasone will be administered orally or intravenously.
Experimental
Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D) 		Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other names:
    • JNJ-64407564
  • Drug: Daratumumab
    Daratumumab will be administered subcutaneously.
  • Drug: Dexamethasone
    Dexamethasone will be administered orally or intravenously.

Recruiting Locations

The University of Arizona Cancer Center
Tucson, Arizona 85719

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205

Norwalk Hospital-oncology
Norwalk, Connecticut 06850

MedStar Georgetown University Hospital
Washington, District of Columbia 20007

George Washington University
Washington, District of Columbia 20037

Memorial Healthcare System
Hollywood, Florida 33021

University of Miami Health System
Miami, Florida 33136

University Of Illinois
Chicago, Illinois 60612

University of Kansas
Westwood, Kansas 66205

Tulane University Hospital & Clinics
New Orleans, Louisiana 70112

Ochsner Health System
New Orleans, Louisiana 70121-2429

Johns Hopkins University
Baltimore, Maryland 21205

Massachusetts General
Boston, Massachusetts 02114

Boston University Medical Center
Boston, Massachusetts 02118

University of Massachusetts Medical School
Worcester, Massachusetts 01655

University of Michigan Health System
Ann Arbor, Michigan 48109

University Of Minnesota
Minneapolis, Minnesota 55455

University of Mississippi Medical Center
Jackson, Mississippi 39216

Washington University School of Medicine
Saint Louis, Missouri 63110-1032

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901

SUNY Upstate Medical University
Syracuse, New York 13210

University of North Carolina
Chapel Hill, North Carolina 27599

Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina 28204

Novant Health
Charlotte, North Carolina 28204

Novant Health
Winston-Salem, North Carolina 27103

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio 43210

OhioHealth
Columbus, Ohio 43214

Thomas Jefferson University
Philadelphia, Pennsylvania 19107-4215

Medical University of South Carolina
Charleston, South Carolina 29425-8900

Baptist Cancer Center
Memphis, Tennessee 38120

Houston Methodist Hospital
Houston, Texas 77030

MD Anderson Cancer Center
Houston, Texas 77030

Joe Arrington Cancer Research Treatment Center
Lubbock, Texas 79410

Huntsman Cancer Institute
Salt Lake City, Utah 84112

University of Virginia
Charlottesville, Virginia 22903

Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia 23298

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109

More Details

NCT ID
NCT05455320
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Detailed Description

Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.

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.