drugset / Trial / NCT02415413
Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma
Phase 2
Active not recruiting
90 enrolled
PETHEMA Foundation
Amgen · collabCelgene Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
Patients included in the study will receive induction treatment during 6 months, followed by receive high-dose therapy followed by peripheral blood stem cell transplantation. Approximately 3 months after peripheral blood stem cell transplantation patients will receive consolidation treatment during 2 months. Subsequently patients will start maintenance treatment during 24 months. Therefore, the total duration of the treatment will be approximately 36 months.
Timeline
- Start
- 2015-05
- Primary completion
- 2018-07-05
- Completion
- 2027-06
Publications
- Mateos MV, Martinez-Lopez J, Rodriguez Otero P, Gonzalez-Calle V, Gonzalez MS, Oriol A, Gutierrez NC, Rios-Tamayo R, Rosinol L, Alvarez Rivas MA, Bargay J, Gonzalez-Rodriguez AP, Alegre A, Escalante F, Inigo Rodriguez MB, De La Rubia J, Teruel AI, de Arriba F, Palomera L, Hernandez MT, Lopez Jimenez J, Reinoso-Segura M, Garcia Mateo A, Ocio EM, Paiva B, Puig N, Cedena MT, Blade J, Lahuerta JJ, San-Miguel JF; Spanish Myeloma Group (GEM-Pethema). Curative Strategy for High-Risk Smoldering Myeloma: Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Followed by Transplant, KRd Consolidation, and Rd Maintenance. J Clin Oncol. 2024 Sep 20;42(27):3247-3256. doi: 10.1200/JCO.23.02771. Epub 2024 Jul 22.
- Puig N, Agullo C, Contreras T, Perez JJ, Aires I, Calasanz MJ, Garcia-Sanz R, Castro S, Martinez-Lopez J, Rodriguez-Otero P, Gonzalez-Calle V, Gonzalez MS, Oriol A, Gutierrez NC, Rios-Tamayo R, Rosinol L, Alvarez MA, Bargay J, Gonzalez-Rodriguez AP, Alegre A, Escalante F, Inigo MB, De la Rubia J, Teruel AI, De Arriba F, Palomera L, Hernandez MT, Lopez-Jimenez J, Reinoso M, Garcia-Mateo A, Ocio EM, Blade J, Lahuerta JJ, Cedena MT, Paiva B, Miguel JFS, Mateos MV. Single-point and kinetics of peripheral residual disease by mass spectrometry to predict outcome in patients with high-risk smoldering multiple myeloma included in the GEM-CESAR trial. Haematologica. 2024 Dec 1;109(12):4056-4066. doi: 10.3324/haematol.2024.285742.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Melphalan | Small molecule | 200 mg/m2 | Intravenous |