Testing linvoseltamab for high-risk smoldering multiple myeloma
Phase 2 Study of Linvoseltamab in Patients With Smoldering Multiple Myeloma at High Risk of Progression to Multiple Myeloma
PHASE2 · Regeneron Pharmaceuticals · NCT05955508
This study is testing a new drug called linvoseltamab to see if it can safely help people with high-risk smoldering multiple myeloma avoid getting worse.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals (industry) |
| Drugs / interventions | linvoseltamab |
| Locations | 17 sites (Santiago de Compostela, A Coruna and 16 other locations) |
| Trial ID | NCT05955508 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of linvoseltamab, an investigational bispecific antibody, in patients diagnosed with high-risk smoldering multiple myeloma (HR-SMM). The study is divided into two parts: the first part focuses on assessing the early side effects of the drug in a small group of participants, while the second part expands the participant pool to further evaluate safety and the drug's ability to prevent progression to multiple myeloma. The trial aims to gather data on how well linvoseltamab eliminates plasma cells and its overall tolerability in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with high-risk smoldering multiple myeloma within the last five years and who meet specific health criteria.
Not a fit: Patients with evidence of myeloma defining events or those diagnosed with symptomatic multiple myeloma or other related conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help prevent the progression of high-risk smoldering multiple myeloma to symptomatic multiple myeloma.
How similar studies have performed: While this approach is novel in the context of high-risk smoldering multiple myeloma, similar studies involving bispecific antibodies have shown promise in treating other forms of multiple myeloma.
Eligibility criteria
Show full inclusion / exclusion criteria
KEY Inclusion Criteria: 1. High-risk SMM diagnosis within 5 years of study enrollment 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 ≥30 mL/min/1.73 m\^2 KEY Exclusion Criteria: 1. Evidence of myeloma defining events \*SLiM CRAB, as described in the protocol \*SLiM (greater than or equal to Sixty percent clonal plasma cells in the bone marrow, involved/uninvolved free Light chain ratio of ≥100 with the involved free light chain (FLC) being ≥100 mg/L, MRI with \>1 focal lesion) CRAB (hyperCalcemia, Renal insufficiency, Anemia, or lytic Bone lesions) 2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple myeloma 3. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol 4. Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first dose of study drug 5. Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection 6. History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as the study drug or excipient NOTE: Other protocol defined inclusion/exclusion criteria apply
Where this trial is running
Santiago de Compostela, A Coruna and 16 other locations
- Hospital Clinico Universitario Santiago de Compostela — Santiago de Compostela, A Coruna, Spain (RECRUITING)
- Hospital Universitario Virgen de las Nieves — Granada, Andalusia, Spain (RECRUITING)
- University Hospital of Cabuenes — Gijon, Asturias, Spain (RECRUITING)
- Hospital Universitari Son Llatzer — Palma Mallorca, Baleares, Spain (RECRUITING)
- Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain (RECRUITING)
- Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain (RECRUITING)
- Hospital Universitario Quiron Salud Madrid — Pozuelo de Alarcon, Madrid, Spain (RECRUITING)
- Hospital Clinico Universitario Virgen De La Arrixaca — El Palmar, Murcia, Spain (RECRUITING)
- Clinica Universidad de Navarra — Pamplona, Navarra, Spain (RECRUITING)
- Hospital Clinic de Barcelona — Barcelona, Spain (RECRUITING)
- Institut Catala d'Oncologia — Barcelona, Spain (RECRUITING)
- Hospital General Universitario Gregorio Maranon — Madrid, Spain (RECRUITING)
- Clinica Universidad de Navarra - Madrid — Madrid, Spain (RECRUITING)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (RECRUITING)
- Hospital Clinico Universitario de Salamanca — Salamanca, Spain (RECRUITING)
- University Hospital Doctor Peset — Valencia, Spain (RECRUITING)
- La Fe University Hospital — Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Smoldering Multiple Myeloma, Linvoseltamab, Multiple Myeloma, B cell maturation antigen, Bispecific antibody