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
- Conditions
- High-Risk Monoclonal Gammopathy of Undetermined Significance; Non-High-Risk Smoldering Multiple Myeloma
- Registration Number
- 2023-505242-25-00
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
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 NHR-SMM?
* What side effects may happen from taking the study drug?
* How much study drug is in the blood at different times?
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 116
- HR-MGUS or NHR-SMM as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate hematologic and hepatic function, as described in the protocol
- Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) equation
Key
- High-risk SMM, as defined in the protocol
- Evidence of any of myeloma-defining events, as described in the protocol
- Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
- Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
- Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of Adverse Events Interest (AEI) during the safety observation period 35 days Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules
Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period 35 days Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Severity of TEAEs during the safety observation period 35 days Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Achievement of Complete Response (CR) as determined by the investigator Up to 5.5 years Part 2
- Secondary Outcome Measures
Name Time Method Frequency of TEAEs Up to 5.5 years As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Severity of TEAEs Up to 5.5 years As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Frequency of Serious Adverse Events (SAEs) Up to 5.5 years Severity of SAEs Up to 5.5 years Frequency of laboratory abnormalities Up to 5.5 years As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Severity of laboratory abnormalities Up to 5.5 years As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Minimal Residual Disease (MRD) negativity among participants that achieve a response of CR Up to 5.5 years Sustained MRD negativity on an annual basis Up to 3 years after achievement of CR Overall response of Partial Response (PR) or better as determined by the investigator Up to 5.5 years Duration Of Response (DOR) as determined by the investigator Up to 5.5 years Biochemical Progression-Free Survival (PFS) as determined by the investigator Up to 5.5 years Concentration of linvoseltamab in serum over time Up to 9 months Incidence of Anti-Drug Antibodies (ADAs) to linvoseltamab over the study duration Up to 5.5. years Magnitude of ADAs to linvoseltamab over the study duration Up to 5.5. years
Trial Locations
- Locations (12)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington
🇺🇸Seattle, Washington, United States
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Andalusia, Spain
Hospital Universitari Mutua Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital de Cabuenes
🇪🇸Gijón, Principality of Asturias, Spain
Hospital Sant Pau
🇪🇸Barcelona, Spain
Scroll for more (2 remaining)Johns Hopkins Hospital🇺🇸Baltimore, Maryland, United States