A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT05455320

Run by

Janssen Research & Development, LLC

People needed

864

Starts

2022-10-13

Expected to finish

2028-05-25

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Norwalk Hospital-oncology — Norwalk, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• University of Miami Health System — Miami, Florida, United States
• University Of Illinois — Chicago, Illinois, United States
• University of Kansas — Westwood, Kansas, United States
• Tulane University Hospital & Clinics — New Orleans, Louisiana, United States
• Ochsner Health System — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• NYU Langone Health — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Levine Cancer Institute, Carolinas HealthCare System — Charlotte, North Carolina, United States
• Novant Health 1 — Charlotte, North Carolina, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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