Testing linvoseltamab for eliminating abnormal plasma cells in patients with high-risk MGUS or smoldering multiple myeloma

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 study aims to evaluate the effectiveness and safety of linvoseltamab in eliminating abnormal plasma cells associated with high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non-high-risk smoldering multiple myeloma (NHR-SMM). Participants will receive gradually increasing doses of the drug to assess its tolerability and short-term side effects in the first five weeks. The study is divided into two parts, with the first part focusing on dose evaluation and the second part on further treatment assessment. The overall goal is to determine if linvoseltamab can effectively reduce the presence of abnormal plasma cells in these patients.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. HR-MGUS or NHR-SMM as defined in the protocol
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Adequate hematologic and hepatic function, as described in the protocol
4. Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation

Key Exclusion Criteria:

1. High-risk SMM, as defined in the protocol
2. Evidence of any of myeloma-defining events, as described in the protocol
3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab
6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• University of Michigan Health
  Ann Arbor, Michigan, United States Recruiting
• NYU Langone Health Perlmutter Cancer Center
  New York, New York, United States Recruiting
• Stony Brook University Hospital
  Stony Brook, New York, United States Recruiting
• Thomas Jefferson University Hospital
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

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

• Multi-omics profiling to predict progression from MGUS and smoldering myeloma to symptomatic multiple myeloma

  This project will try to see if combined genomic, immune, and oral microbiome tests can predict which people with MGUS or smoldering myeloma will progress to symptomatic multiple myeloma.

  Recruiting Azienda USL Reggio Emilia - IRCCS · Bologna and 3 other locations · NCT07214324

• Identifying precancerous multiple myeloma in African American adults

  This study is testing a way to find early signs of multiple myeloma in Black and African American adults aged 30 and older to help catch it sooner and improve their health outcomes.

  Recruiting Wake Forest University Health Sciences · Charlotte, North Carolina · NCT06644625

• Linvoseltamab with pre-dose Tocilizumab to reduce CRS in adults with relapsed/refractory multiple myeloma

  This study tests whether giving tocilizumab before the first dose of linvoseltamab can lower the risk of cytokine release syndrome in adults with relapsed/refractory multiple myeloma who have had at least four prior therapies.

  Recruiting at 7 sites Phase 4 Regeneron Pharmaceuticals · Los Angeles, California and 6 other locations · NCT07609940

• REGN17372 plus linvoseltamab tolerability for adults with relapsed/refractory multiple myeloma

  This trial tests whether giving REGN17372 together with linvoseltamab is safe and what dose works for adults whose multiple myeloma has come back or stopped responding.

  Recruiting at 9 sites Phase 1/2 Regeneron Pharmaceuticals · Liverpool, New South Wales and 8 other locations · NCT07455851

• Linvoseltamab vs. Daratumumab in high-risk smoldering myeloma

  This study tests whether linvoseltamab can delay progression to active myeloma better than daratumumab in people with high-risk smoldering multiple myeloma.

  Recruiting at 33 sites Phase 3 Regeneron Pharmaceuticals · Phoenix, Arizona and 32 other locations · NCT07393282

• Linvoseltamab alone or with carfilzomib versus standard combination regimens for adults with relapsed/refractory multiple myeloma.

  This trial tests whether linvoseltamab alone or together with carfilzomib works better than standard combination treatments for adults with relapsed or refractory multiple myeloma who have had 1–3 prior therapies.

  Recruiting at 53 sites Phase 3 Regeneron Pharmaceuticals · Atlanta, Georgia and 52 other locations · NCT07222761

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.