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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic Hospital Scottsdale /ID# 278349
  Scottsdale, Arizona, United States Recruiting
• Cedars-Sinai Medical Center /ID# 278238
  Los Angeles, California, United States Recruiting
• Colorado Blood Cancer Institute /ID# 279080
  Denver, Colorado, United States Recruiting
• Winship Cancer Institute of Emory University /ID# 277667
  Atlanta, Georgia, United States Recruiting
• Fort Wayne Medical Oncology And Hematology /ID# 278141
  Fort Wayne, Indiana, United States Recruiting
• Minnesota Oncology - Minneapolis Clinic /ID# 278720
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining JNJ-79635322 with Daratumumab or Pomalidomide for Multiple Myeloma Treatment

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.