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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06140524
Other study ID # R5458-ONC-2257
Secondary ID 2023-505242-25-0
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 15, 2024
Est. completion date May 12, 2032

Study information

Verified date May 2024
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non high-risk smoldering multiple myeloma (NHR-SMM). This requires understanding the safety and tolerability of the study drug (how the body reacts to linvoseltamab) as well as the effectiveness of the study drug (how well linvoseltamab eliminates plasma cells). All participants will start treatment with gradually increasing doses of linvoseltamab (step-up doses) before they start receiving the assigned full dose. The study is split into 2 parts: - In Part 1, separate groups of 3-6 patients will receive different full doses of linvoseltamab to evaluate the short-term side effects (safety) and tolerability of the study drug within the first 5 weeks after starting treatment. The data collected will help to make a decision about the dosing regimens chosen for Part 2. - In Part 2, a larger number of participants will be randomized to different dosing regimens to further assess the side effects of linvoseltamab, and to evaluate the ability of linvoseltamab to eliminate abnormal plasma cells in 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 104
Est. completion date May 12, 2032
Est. primary completion date May 12, 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 m2 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 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 NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Linvoseltamab
Administration by intravenous (IV) infusion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of adverse events of special interest (AESI) during the safety observation period Part 1 As assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system version 5 (for all grades). AESI include grade 2 or higher cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), grade 3 or higher tumor lysis syndrome (TLS), infusion-related reaction (IRR), allergic reactions, infections and hepatitis B virus (HBV) reactivation 35 days
Primary Frequency of treatment-emergent adverse event (TEAEs) during the safety observation period Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades) 35 days
Primary Severity of TEAEs during the safety observation period Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades) 35 days
Primary Achievement of complete response (CR) as determined by the investigator Part 2 Up to 5.5 years
Secondary Frequency of TEAEs As assessed by the NCI-CTCAE grading system version 5 (for all grades) Up to 5.5 years
Secondary Severity of TEAEs As assessed by the NCI-CTCAE grading system version 5 (for all grades) Up to 5.5 years
Secondary Frequency of serious adverse events (SAEs) Up to 5.5 years
Secondary Severity of SAEs Up to 5.5 years
Secondary Frequency of laboratory abnormalities As assessed by the NCI-CTCAE grading system version 5 (for all grades) Up to 5.5 years
Secondary Severity of laboratory abnormalities As assessed by the NCI-CTCAE grading system version 5 (for all grades) Up to 5.5 years
Secondary Minimal residual disease (MRD) negativity among participants that achieve a response of CR Up to 5.5 years
Secondary Sustained MRD negativity on an annual basis Up to 3 years after achievement of CR
Secondary Overall response of partial response (PR) or better as determined by the investigator Up to 5.5 years
Secondary Duration of response (DOR) as determined by the investigator Up to 5.5 years
Secondary Biochemical progression-free survival (PFS) as determined by the investigator Up to 5.5 years
Secondary Concentration of linvoseltamab in serum over time Up to 9 months
Secondary Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time Up to 9 months
Secondary Titer of ADAs to linvoseltamab over time Up to 9 months
See also
  Status Clinical Trial Phase
Recruiting NCT05955508 - A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma Phase 2
Active, not recruiting NCT02240537 - Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer Phase 1
Recruiting NCT04731844 - Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer Phase 2