- Completed
NCT02406144: Phase 3 - GEM2014MAIN - Maintenance Len, Dex VS Len, Dex. & MLN9708 After ASCT NDMM
Updated: Oct 4, 2022
GEM14
Phase III GEM2014MAIN: Maintenance With Ixazomib + Len/Dex vs Len/Dex After VRd + ASCT in Newly Diagnosed MM
Trial Studying Maintenance Treatment With Lenalidomide and Dexamethasone Versus Lenalidomide, Dexamethasone and MLN9708 After Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly-diagnosed Symptomatic Multiple Myeloma
NCT02406144: Phase 3 - Maintenance With Lenalidomide and Dexamethasone Versus Lenalidomide, Dexamethasone and MLN9708 After ASCT NDMM
This protocol is a randomized, open-label, national, multicenter trial studying maintenance treatment with lenalidomide and dexamethasone versus lenalidomide, dexamethasone and MLN9708 after autologous hematopoietic stem cell transplantation in patients with newly-diagnosed symptomatic multiple myeloma.
A total of 316 patients, from the study GEM2012MENOS65, will be enrolled in the study.
The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study. The patient is then assessed to determine his/her eligibility. The selection process will begin 21 days before the first dose of medication is administered (days -21 to 0). All procedures during the pre-treatment period will be carried out after completion of the two cycles of post-transplant consolidation with VRD which coincide with the end-of-study visit of clinical trial GEM2012MENOS65.
Sponsor
Collaborators
ClinicalTrials.gov Identifier: NCT02406144
Trial Studying Maintenance Treatment With Lenalidomide and Dexamethasone Versus Lenalidomide, Dexamethasone and MLN9708 After Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly-diagnosed Symptomatic Multiple Myeloma
First Posted : April 2, 2015
Click here for details on ClinicalTrials.gov
Drug: MLN9708
Drug: Lenalidomide
Drug: Dexamethasone
PETHEMA/GEM
Spanish Myeloma Group
GEM (Grupo Español de Mieloma)/PETHEMA (Programa para el Estudio de la Terapéutica en Hemopatías Malignas) Cooperative Study Group
466 Ixazomib Plus Lenalidomide/Dexamethasone (IRd) Versus Lenalidomide /Dexamethasone (Rd) Maintenance after Autologous Stem Cell Transplant in Patients with Newly Diagnosed Multiple Myeloma: Results of the Spanish GEM2014MAIN Trial
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials; treatment of NDMM and amyloidosis patients
Hematology Disease Topics & Pathways:
Clinical Trials, Non-Biological, Clinical Research, Plasma Cell Disorders, Diseases, Therapies, Lymphoid Malignancies, Pharmacology
Sunday, December 12, 2021: 12:45 PM
FlowCT for the analysis of large immunophenotypic data sets and biomarker discovery in cancer immunology
Blood Adv; 2022 Jan
FlowCT is a new open-source computational approach that can be readily implemented by research laboratories to perform quality control, analyze high-dimensional data, unveil cellular diversity, and objectively identify biomarkers in large immune monitoring studies
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
NCT02415413: Phase 2 - Carfilzomib in Patients Under 65 With High Risk Smoldering MM (GEM-CESAR trial)
NCT03336073: Phase 2: GEM-KyCyDex - Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma
NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma
NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide
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