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Etentamig plus daratumumab versus daratumumab‑lenalidomide‑dexamethasone for newly diagnosed multiple myeloma in patients not eligible for transplant

Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Phase2; Phase3 Interventional AbbVie · NCT07095452

This trial will test whether adding the investigational drug etentamig to daratumumab helps control disease and is safe in adults newly diagnosed with multiple myeloma who cannot have a transplant.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment660 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, daratumumab
Locations39 sites (Scottsdale, Arizona and 38 other locations)
Trial IDNCT07095452 on ClinicalTrials.gov

What this trial studies

This international phase 2/3 program will first test three IV dose levels of etentamig given with daratumumab in phase 2 to choose a recommended phase 3 dose and characterize safety and pharmacokinetics. In phase 3 participants will receive the selected etentamig dose plus daratumumab or the standard daratumumab, lenalidomide, and dexamethasone (DRd) regimen to compare changes in disease activity and adverse events. About 660 adults with newly diagnosed, measurable multiple myeloma judged ineligible for high‑dose chemotherapy and stem cell transplant will be enrolled across roughly 155 global sites. Key entry criteria include measurable disease per central lab, an IMWG frailty score ≥1, and no prior systemic myeloma therapy or stem cell transplant.

Who should consider this trial

Good fit: Adults with newly diagnosed, measurable multiple myeloma who are judged not suitable for high‑dose chemotherapy and autologous stem cell transplant and who meet the trial's frailty and laboratory criteria.

Not a fit: Patients who are eligible for autologous stem cell transplant, who have had prior systemic myeloma therapy, or who do not meet measurable disease criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding etentamig could improve disease control and extend the time before progression for patients who cannot undergo transplant.

How similar studies have performed: Daratumumab plus lenalidomide and dexamethasone (DRd) is an established effective regimen in transplant‑ineligible myeloma, but combining daratumumab with the investigational agent etentamig is a novel approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT).
* IMWG Myeloma Frailty Index Score of \>= 1
* All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:

  * Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
  * Urine M-protein \>= 200 mg/24 hours.
  * Serum free light chain (FLC) \>= 100 mg/L (\>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.

Exclusion Criteria:

* Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
* Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
* Participant who has known active central nervous system involvement of MM.
* Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.

Where this trial is running

Scottsdale, Arizona and 38 other locations

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 MyelomaEtentamigDaratumumabLenalidomideDexamethasone
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.