PHASE 2 DOSE-RANGING AND INTERCEPTION STUDY OF LINVOSELTAMAB IN PATIENTS WITH HIGH-RISK MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE OR NON-HIGH-RISK SMOLDERING MULTIPLE MYELOMA
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase II
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Leucemia mieloide aguda, Mieloma Múltiple y otras gammapatías, Trasplante de progenitores hematopoyéticos, Linfoma
CENTRO INVESTIGADOR
H.U. de La Princesa
INVESTIGADOR PRINCIPAL
Adrián Alegre Amor
FECHA DE APERTURA
Mayo, 2024
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
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 m2 by the modification of diet in renal disease (MDRD) equation.
NOTE: Other protocol defined inclusion criteria apply
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 m2 by the modification of diet in renal disease (MDRD) equation.
NOTE: Other protocol defined inclusion criteria apply
CRITERIOS DE EXCLUSIÓN
High-risk SMM according to risk stratification models 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 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.
NOTE: Other protocol defined exclusion criteria apply
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 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.
NOTE: Other protocol defined exclusion criteria apply
DESCRIPCIÓN
Safety Run-In (Part 1): To evaluate the safety and tolerability of linvoseltamab in ascending dose-level cohorts and select the highest dose level for investigation in the expansion part. Expansion (Part 2): To evaluate the ability of linvoseltamab to induce complete responses (CR) by dosing regimen.
PALABRAS CLAVE
donor lymphocyte infusion, emr, leucemia linfocítica crónica (llc / cll), monoclonal gammopathy, multiple myeloma, myeloma, ph + acute lymphoblastic leukemia, smoldering myeloma
