Study on Comparing Etentamig and Daratumumab with Standard Treatment for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant
Sponsor: AbbVie
ClinicalTrials ID:NCT07095452
This clinical trial is testing a new drug, Etentamig, combined with Daratumumab, against a standard treatment for adults with newly diagnosed multiple myeloma who cannot undergo a transplant. The study aims to see how well the treatments work and their side effects.
Patient Parameters
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Program Overview
Multiple myeloma is a type of blood cancer that affects plasma cells, often found in bones and bone marrow. This study is testing a new drug called Etentamig, combined with Daratumumab, to see if it can help treat multiple myeloma. The study is divided into two phases. In the first phase, participants will receive different doses of Etentamig with Daratumumab. In the second phase, participants will receive either the best dose of Etentamig with Daratumumab or a standard treatment of Daratumumab, Lenalidomide, and Dexamethasone. About 660 adults will participate in this study, which will take place at around 155 locations worldwide. Participants will receive the treatments through infusions and injections and will have regular check-ups to monitor the effects and any side effects. The study will last approximately 16 years.
Eligibility Criteria
Inclusion Criteria
- Must have a new diagnosis of multiple myeloma and not be suitable for high-dose chemotherapy and stem cell transplant due to health factors.
- Must have a Myeloma Frailty Index Score of 1 or higher.
- Must have measurable disease with at least one of the following:
- Serum M-protein of 0.5 g/dL or higher.
- Urine M-protein of 200 mg/24 hours or higher.
- Serum free light chain of 100 mg/L or higher and an abnormal kappa lambda ratio if no measurable serum or urine M-protein.
Exclusion Criteria
- Have had previous systemic therapy or stem cell transplant for multiple myeloma, except for a short course of corticosteroids.
- Have received any investigational treatment within 30 days or 5 half-lives of the treatment before the first dose of the study treatment.
- Have active central nervous system involvement of multiple myeloma.
- Have a history of significant health issues affecting kidneys, nerves, mental health, hormones, metabolism, immune system, lungs, or liver in the last 6 months that could affect participation in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Colorado Blood Cancer Institute /ID# 279080 | 80218 | Denver | Colorado |
| Fort Wayne Medical Oncology And Hematology /ID# 278141 | 46804 | Fort Wayne | Indiana |
| Minnesota Oncology - Minneapolis Clinic /ID# 278720 | 55404 | Minneapolis | Minnesota |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946 | 10065 | New York | New York |
| Willamette Valley Cancer Institute and Research Center /ID# 278721 | 97401 | Eugene | Oregon |
| SCRI Oncology Partners /ID# 278353 | 37203 | Nashville | Tennessee |
| Texas Oncology - The Woodlands /ID# 278726 | 77380 | The Woodlands | Texas |
| Texas Oncology - Northeast Texas /ID# 278725 | 75702 | Tyler | Texas |
| Virginia Cancer Specialists - Fairfax /ID# 278716 | 22031 | Fairfax | Virginia |
| Blue Ridge Cancer Care - Roanoke /ID# 278722 | 24014 | Roanoke | Virginia |
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