• Completed

NCT02406144: Phase 3 - GEM2014MAIN - Maintenance Len, Dex VS Len, Dex. & MLN9708 After ASCT NDMM

Updated: Oct 4

GEM14

Phase III GEM2014MAIN: Maintenance With Ixazomib + Len/Dex vs Len/Dex After VRd + ASCT in Newly Diagnosed MM

GEM2014 MAIN pethema myeloma trial

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

PETHEMA Foundation


Collaborators

Celgene

Millennium Pharmaceuticals, Inc.

 

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

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Ixazomib: National Cancer Institute

Ixazomib: MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

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

Learn more

 

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

Learn more

 

Location

Spain

 

Spanish Myeloma Group (GEM-PETHEMA) Posts



NCT00480363: Phase 3: Revlimid / Dex ( ReDex) VS Observation in Smoldering MM (QUIREDEX)

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NCT00461747: Phase 3 - GEM05 for Patients With Multiple Myeloma Under 65 Years (GEM05MENOS65)

Click here for details


NCT01916252: Phase 3 - Bortezomib, Lenalidomide & IV Busulfan Under 65 - (GEM2012MENOS65) PETHEMA

Click here for details


NCT02415413: Phase 2 - Carfilzomib in Patients Under 65 With High Risk Smoldering MM (GEM-CESAR trial)

Click here for details


NCT03336073: Phase 2: GEM-KyCyDex - Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma

Click here for details


NCT04802356: Phase 2: Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma

Click here for details


NCT05060627: Phase 1/2: Belantamab Mafodotin + Kd RRMM Multiple Myeloma, Refractory to Lenalidomide

Click here for details

 

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