A Phase 2/3 Multicenter Randomized Open-Label Study Evaluating the Efficacy & Safety of Etentamig and Daratumumab Compared to Daratumumab, Lenalidomide, and Dexamethasone in Subjects with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Clinical Trial Details

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM.

Etentamig is an investigational drug being developed for the treatment of MM. Investigational means that it is not approved by the U.S. Food and Drug Administration (FDA).

This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms.

Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab.

Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). T

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

The study duration is approximately 16 years.

Key Eligibility:

Inclusion Criteria:

Participants must have confirmed new diagnosis of multiple myeloma 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).

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.

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Ruben Niesvizky, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2601029733

ClinicalTrials.gov:

NCT07095452

Status

Open to Enrollment

Age Group

Adult

Disease

Multiple Myeloma