- Active, not recruiting
NCT02415413: Phase 2 - Carfilzomib in Patients Under 65 With High Risk Smoldering MM GEM-CESAR trial
Updated: Sep 19, 2022
GEM-CESAR trial
PETHEMA/GEM
Spanish Myeloma Group
GEM (Grupo Español de Mieloma)/PETHEMA (Programa para el Estudio de la Terapéutica en Hemopatías Malignas) Cooperative Study Group
KRd
Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma
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.
Sponsor
Collaborators
ClinicalTrials.gov Identifier: NCT02415413
Official Title: A Phase II Multicenter Study of Carfilzomib, Lenalidomide and Dexamethasone (KRd) as Induction Therapy, Followed by High-dose Therapy With Melphalan and Autologous Peripheral Blood Stem Cell Transplantation, Consolidation With KRd, and Maintenance With Lenalidomide and Dexamethasone in Patients ≤ 70 Years Old With Smoldering Multiple Myeloma (SMM) With High Risk of Progression to Symptomatic Myeloma
First Posted : April 14, 2015
Click here for details on ClinicalTrials.gov
1829 Curative Strategy (GEM-CESAR) for High-Risk Smoldering Myeloma (SMM): Carfilzomib, Lenalidomide and Dexamethasone (KRd) As Induction Followed By HDT-ASCT, Consolidation with Krd and Maintenance with Rd
Program: Oral and Poster Abstracts
Session: 731. Autologous Transplantation: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Clinical Trials, Workforce, Plasma Cell Disorders, Diversity, Equity, Inclusion, and Accessibility (DEI/DEIA) , Diseases, Therapies, Lymphoid Malignancies, Study Population, Clinical Practice (e.g. Guidelines, Health Outcomes and Services, and Survivorship, Value; etc.)
Saturday, December 11, 2021, 5:30 PM-7:30 PM
Analysis of treatment efficacy in the GEM-CESAR trial for high-risk smoldering multiple myeloma patients: Comparison between the standard and IMWG MRD criteria and QIP-MS including FLC (QIP-FLC-MS)
2020 ASCO Annual Meeting
Abstracts; 8512
Curative Strategy (GEM-CESAR) for High-Risk Smoldering Myeloma (SMM): Carfilzomib, Lenalidomide and Dexamethasone (KRd) As Induction Followed By HDT-ASCT, Consolidation with Krd and Maintenance with Rd
731.CLINICAL AUTOLOGOUS TRANSPLANTATION: RESULTS| NOVEMBER 13, 2019
Blood (2019) 134 (Supplement_1): 781.
Curative Strategy for High-Risk Smoldering Myeloma (GEM-CESAR) Jan 3, 2018
How do the two approaches to treating high-risk smoldering multiple myeloma (HRSMM) patients differ? Feb 8, 2018
Curative Strategy (GEM-CESAR) for High-Risk Smoldering Myeloma (SMM) Dec 13, 2019
Qip-Mass Spectrometry in High Risk Smoldering Multiple Myeloma Pts Included in the GEM-CESAR Trial Dec 16, 2019
Analysis of treatment efficacy in the GEM-CESAR trial for high-risk smoldering multiple myeloma pts Jun 11, 2020
Learn more:
Location
Spain
Spanish Myeloma Group (GEM-PETHEMA) Posts
NCT00480363: Phase 3: Revlimid / Dex ( ReDex) VS Observation in Smoldering MM (QUIREDEX)
NCT00461747: Phase 3 - GEM05 for Patients With Multiple Myeloma Under 65 Years (GEM05MENOS65)
NCT01916252: Phase 3 - Bortezomib, Lenalidomide & IV Busulfan Under 65 - (GEM2012MENOS65) PETHEMA
NCT02406144: Phase 3 - Maint. Lenalidomide, Dex VS Lenalidomide, Dex. & MLN9708 After ASCT NDMM
NCT03336073: Phase 2: GEM-KyCyDex - Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma
NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma
CT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide