Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Run by AbbVie · NCT07793422 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2034-12.
Amyloid light chain (AL) amyloidosis is a rare disease caused by abnormal plasma cells producing misfolded light chain proteins that deposit in organs, leading to organ dysfunction and failure. The goal of this study is to evaluate the safety and efficacy of etentamig compared to daratumumab plus cyclophosphamide plus bortezomib plus dexamethasone (Dara-CyBorD) in participants with newly diagnosed AL amyloidosis. Etentamig is an investigational drug being developed for the treatment of newly diagnosed AL amyloidosis. This is an open-label study. The study consists of 2 parts: a Safety Run-in …
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 370 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | Etentamig, Daratumumab, Cyclophosphamide, Bortezomib, Dexamethasone, Bortezomib, Cyclophosphamide, Dexamethasone |
| Trial ID | NCT07793422 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red-stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance. * Evidence of a monoclonal plasma cell proliferative disorder (serum or urine monoclonal protein, abnormal free light-chain ratio, or clonal plasma cells in the bone marrow). * Measurable disease of amyloid light chain (AL) amyloidosis as defined by difference in free light chains (dFLC) \>= 50 mg/L * No history of treatment with anti-amyloidosis therapy. * Presence of an amyloid-related systemic syndrome with at least 1 organ impacted by AL amyloidosis according to International Myeloma Working Group (IMWG) diagnostic criteria. * Considered AL amyloidosis cardiac risk stage 1, 2, or 3a (or 3b \[randomized portion only\]). * Eastern Cooperative Oncology Group performance status \<= 2. Exclusion Criteria: * Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatments. * Active hepatitis B or hepatitis C infection. * History of other active malignancies within the past 3 years (with specified exceptions).
Study contacts
- Principal investigator: Abbvie INC. — AbbVie
- 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.
-
Daratumumab-hyaluronidase added to your myeloma treatment to see if it helps kidney function
This trial tests whether adding daratumumab-hyaluronidase to the standard bortezomib and dexamethasone therapy improves kidney function in adults newly diagnosed with multiple myeloma and kidney failure.
-
Treatment for newly diagnosed monoclonal immunoglobulin deposition disease
This study is testing a new combination treatment for people who have just been diagnosed with monoclonal immunoglobulin deposition disease to see if it helps improve their blood health.
-
Induction treatment for newly diagnosed multiple myeloma patients with renal failure
This study is testing a new treatment plan for people with newly diagnosed multiple myeloma and kidney problems to see if it helps them respond better to therapy.
-
Combining CyBorD with Daratumumab for treating kidney disease related to monoclonal gammopathy
This study is testing a new treatment combining CyBorD and daratumumab to see if it can help people with kidney disease caused by monoclonal gammopathy feel better and improve their kidney function.
-
Comparing chemotherapy with and without stem cell transplant for AL amyloidosis
This study is testing whether adding a stem cell transplant to chemotherapy can help people with newly diagnosed AL amyloidosis live longer and have better organ health.
-
Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.