A Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase II-III
PATOLOGÍA
Mieloma Múltiple y otras gammapatías
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Cristina Encinas
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Joaquin Martinez Lopez
CENTRO INVESTIGADOR
H.U. Ramón y Cajal
INVESTIGADOR PRINCIPAL
Maria Jesus Blanchard
FECHA DE APERTURA
Febrero, 2026
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Participants must have confirmed NDMM according to the IMWG diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.
International Myeloma Working Group (IMWG) Myeloma Frailty Index Score of 1
Eastern Cooperative Oncology Group (ECOG) performance of 1
All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: Serum M-protein 0.5 g/dL ( 5 g/L). Urine M-protein 200 mg/24 hours. Serum free light chain (FLC) 100 mg/L ( 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.
International Myeloma Working Group (IMWG) Myeloma Frailty Index Score of 1
Eastern Cooperative Oncology Group (ECOG) performance of 1
All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: Serum M-protein 0.5 g/dL ( 5 g/L). Urine M-protein 200 mg/24 hours. Serum free light chain (FLC) 100 mg/L ( 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.
CRITERIOS DE EXCLUSIÓN
Prior or current systemic therapy or SCT for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
Participants received treatment with anti-cancer therapy (including chemotherapy, radiotherapy, biologics, immunotherapy, cellular therapies and/or steroids at doses > 20 mg dexamethasone or equivalent) or undergone a major surgical procedure within 21 days or within 5 half-lives of an anticancer therapy, prior to the first dose of study treatment, whichever is shorter
Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
Participant who has known active central nervous system involvement of Multiple Myeloma (MM)
Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study
Participants received treatment with anti-cancer therapy (including chemotherapy, radiotherapy, biologics, immunotherapy, cellular therapies and/or steroids at doses > 20 mg dexamethasone or equivalent) or undergone a major surgical procedure within 21 days or within 5 half-lives of an anticancer therapy, prior to the first dose of study treatment, whichever is shorter
Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
Participant who has known active central nervous system involvement of Multiple Myeloma (MM)
Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study
DESCRIPCIÓN
Phase 2: To determine the RP3D of etentamig in combination with daratumumab in partcipants with Newly Diagnosed Multiple Myeloma (NDMM) that are not eligible for transplant Phase 3: To evaluate the efficacy of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant To evaluate the efficacy of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant
PALABRAS CLAVE
multiple myeloma, myeloma
