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Comparing Talquetamab with Daratumumab and Pomalidomide for Multiple Myeloma

A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Phase 3 Interventional Janssen Research & Development, LLC · NCT05455320

This study is testing whether a new combination of talquetamab and daratumumab, with or without pomalidomide, works better than the standard treatment for people with relapsed or hard-to-treat multiple myeloma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment810 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsprednisone, talquetamab, daratumumab
Locations216 sites (Tucson, Arizona and 215 other locations)
Trial IDNCT05455320 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of talquetamab when combined with daratumumab, with or without pomalidomide, against a standard treatment of daratumumab combined with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Participants will receive one of the treatment combinations to determine which is more effective in managing their condition. The study aims to provide insights into new treatment options for patients whose disease has returned or is resistant to previous therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with documented multiple myeloma that has returned after treatment or is resistant to treatment.

Not a fit: Patients with newly diagnosed multiple myeloma or those who have not yet received treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating multiple myeloma, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Tucson, Arizona and 215 other locations

+166 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed or Refractory Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.