Trial NCT06140524
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
- Phase
- Phase 2
- Sponsor
- Regeneron Pharmaceuticals
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS); Smoldering Multiple Myeloma (SMM)
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
1. HR-MGUS or NHR-SMM as defined in the protocol
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1Performance status
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) equationRenal
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 protocolCardiac
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) infectionHIV; or other uncontrolled infection or unexplained signs of infection, as described in the protocol
NOTE: Other protocol defined inclusion/exclusion criteria apply
Restrictions found (4)
- CardiacConditionalexclusionShow in the text
- HIVConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG ≤1
Show in the text - RenalOutrightinclusion
GFR ≥30 mL/min/1.73 m^2
Show in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County