A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
Recruiting · Phase 2 · NCT06140524
Conditions: Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM)
At a glance
- Research payments reported, 2025
- $1.4M
- U.S. investigators named
- 8
- Sites paid
- 7
- Planned or actual enrollment
- 116
About the trial
- Sponsor
- Regeneron Pharmaceuticals
- Tested
- Linvoseltamab (drug)
- Dates
- Started 2024-09-16; completion 2032-05-18
- Results posted
- Not yet
This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement of their HR-MGUS or…
From ClinicalTrials.gov, last updated 2026-07-08. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $1.4M in research payments for this study in 2025 (117 payments).
Products named: Lynozyfic
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Irene M. Ghobrial, M.D. Medical Oncology · Boston, MA
- Elizabeth K. O'donnell, MD Internal Medicine · Boston, MA
- Christian B. Gocke, M.D., PH.D. Medical Oncology · Baltimore, MD
- Matthew J. Pianko, M.D. Hematology · Ann Arbor, MI
- Michael W. Schuster, MD Hematology & Oncology · New York, NY
- Adam F. Binder, MD Hematology & Oncology · Philadelphia, PA
- Andrew J. Cowan, M.D. Hematology & Oncology · Seattle, WA
- Madhav V. Dhodapkar, MD Hematology & Oncology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Dana-Farber Cancer Institute $609,567
- Johns Hopkins University $252,889
- Dana Farber Mass General Brigham Cancer Care Inc $214,833
- University of Washington Medical Ctr, WA $111,503
- Thomas Jefferson University $105,848
- The Research Foundation for The State University of New York $77,428
- University of Michigan Health System, MI $34,245
- $4,657
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.