Curative Strategy for High-Risk Smoldering Myeloma: Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Followed by Transplant, KRd Consolidation, and Rd Maintenance

Early treatment of high-risk smoldering myeloma has been shown to delay progression to multiple myeloma (MM). We conducted this trial with curative intention using a treatment approach employed for newly diagnosed patients with MM. Patients with high-risk smoldering myeloma (>50% progression risk...

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Bibliographic Details
Authors: Mateos, María-Victoria, Martínez-López, Joaquin, Rodriguez Otero, Paula, González-Calle, Verónica, Gonzalez, Marta Sonia, Oriol, Albert, Gutiérrez, Norma C, Ríos-Tamayo, Rafael, Rosiñol, Laura, Alvarez Rivas, Miguel Angel, Bargay Lleonart, Joan, Gonzalez-Rodriguez, Ana Pilar, Alegre, Adrián, Escalante, Fernando, Iñigo Rodríguez, María Belén, de la Rubia, Javier, Teruel, Ana Isabel, de Arriba, Felipe, Palomera, Luis, Hernández, Miguel T, Lopez Jiménez, Javier, Reinoso-Segura, Marta, García Mateo, Aránzazu, Ocio, Enrique M, Paiva, Bruno, Puig, Noemi, Cedena, Maria Teresa, Bladé, Joan, Lahuerta, Juan Jose, San-Miguel, Jesus F
Format: article
Publication Date:2024
Country:España
Institution:Conselleria de Salut i Consum del Govern de les Illes Balears
Repository:Docusalut
Language:English
OAI Identifier:oai:docusalut.com:20.500.13003/21129
Online Access:https://hdl.handle.net/20.500.13003/21129
Access Level:Open access
Keyword:Disease Progression
Aged
Hematopoietic Stem Cell Transplantation
Adult
Transplantation, Autologous
Humans
Melphalan
Antineoplastic Combined Chemotherapy Protocols
Smoldering Multiple Myeloma
Middle Aged
Oligopeptides
Consolidation Chemotherapy
Lenalidomide
Male
Multiple Myeloma
Maintenance Chemotherapy
Female
Dexamethasone
Lenalidomida
Mieloma Múltiple Quiescente
Dexametasona
Mieloma Múltiple
Femenino
Quimioterapia de Consolidación
Quimioterapia de Mantención
Masculino
Oligopéptidos
Humanos
Persona de Mediana Edad
Trasplante de Células Madre Hematopoyéticas
Protocolos de Quimioterapia Combinada Antineoplásica
Melfalán
Anciano
Progresión de la Enfermedad
Trasplante Autólogo
Adulto
Description
Summary:Early treatment of high-risk smoldering myeloma has been shown to delay progression to multiple myeloma (MM). We conducted this trial with curative intention using a treatment approach employed for newly diagnosed patients with MM. Patients with high-risk smoldering myeloma (>50% progression risk at 2 years) and transplant candidates were included and received induction therapy with carfilzomib, lenalidomide, and dexamethasone (KRd), six cycles, followed by high-dose melphalan (200 mg/m2) autologous stem-cell transplantation (HDM-ASCT), two KRd consolidation cycles, and Rd maintenance for 2 years. The primary end point was undetectable measurable residual disease (uMRD) rate by next-generation flow after ASCT. Sustained uMRD 4 years after ASCT was the secondary end point. Between June 2015 and June 2017, 90 patients were included, and 31% met at least one SixtyLightchain MRI (SLiM)-hypercalcemia, renal impairment, anemia, bone disease (CRAB) criterion. After a median follow-up of 70.1 months, 3 months after ASCT, in the intention-to-treat population, 56 (62%) of 90 patients had uMRD, and 4 years later, it was sustained in 29 patients (31%). Five patients progressed to MM, and the 70-month progression rate was 94% (95% CI, 84 to 89). The presence of any SLiM CRAB criteria predicted progression to MM (four of the five patients; hazard ratio, 0.12; 95% CI, 0.14 to 1.13; P = .03). Thirty-six patients showed biochemical progression, and failure to achieve uMRD at the end of treatment predicted it. The 70-month overall survival was 92% (95% CI, 82 to 89). Neutropenia and infections were the most frequent adverse events during treatment, resulting in one treatment-related death. Three second primary malignancies have been reported. Although a longer follow-up is needed, this curative approach is encouraging and more effective than active MM, with 31% of the patients maintaining the uMRD 4 years after HDM-ASCT.