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Combining teclistamab and talquetamab with daratumumab and lenalidomide for newly diagnosed multiple myeloma

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

Phase 3 Interventional Janssen Research & Development, LLC · NCT05552222

This study is testing two new treatment combinations for people with newly diagnosed multiple myeloma to see if they work better than the standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1590 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsteclistamab, talquetamab, daratumumab, chemotherapy
Locations265 sites (Gilbert, Arizona and 264 other locations)
Trial IDNCT05552222 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of two treatment combinations for patients with newly diagnosed multiple myeloma. Participants will receive either teclistamab combined with daratumumab and lenalidomide or talquetamab combined with daratumumab and lenalidomide, and these will be compared against a standard treatment of daratumumab, lenalidomide, and dexamethasone. The goal is to determine which combination provides better outcomes for patients who are not candidates for high-dose chemotherapy with autologous stem cell transplant.

Who should consider this trial

Good fit: Ideal candidates are individuals who have been newly diagnosed with multiple myeloma and are not eligible for high-dose chemotherapy with autologous stem cell transplant.

Not a fit: Patients who have previously received therapy for multiple myeloma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer more effective treatment options for patients with newly diagnosed multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating multiple myeloma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
* Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* 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
* A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment

Exclusion Criteria:

* Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization
* Had plasmapheresis within 28 days of randomization
* Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
* Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
* Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
* Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone

Where this trial is running

Gilbert, Arizona and 264 other locations

+215 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 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.