top of page
  • Completed

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

Updated: Sep 19, 2022

Phase III study PETHEMA (GEM2012MENOS65)




Spanish Myeloma Group

GEM (Grupo Español de Mieloma)/PETHEMA (Programa para el Estudio de la Terapéutica en Hemopatías Malignas) Cooperative Study Group


This protocol is a national, multicenter, comparative, open-label, randomized trial comparing the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL versus. MEL-200).

A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits will take place during the pre-treatment, treatment and follow-up periods.

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). During the treatment period, eligible patients will be included in the study and given six cycles of induction treatment with bortezomib/ lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.

After the first three induction cycles, and in the absence of progression or unacceptable toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take place at the beginning of the study, once the screening is complete and the patient's eligibility verified. Three months after transplantation, patients will receive two cycles of consolidation treatment with VRD-GEM at the same doses administered during induction treatment.

Once the treatment phase is complete, patients will begin the follow-up phase in which they will be visited every three months to evaluate disease progression and survival




Pierre Fabre Medicament Identifier: NCT01916252

Official Title: A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed, Symptomatic Multiple Myeloma

First Posted : August 5, 2013

Click here for details on






Bortezomib, lenalidomide, and dexamethasone as induction therapy prior to autologous transplant in multiple myeloma.

Blood. 2019 Oct 17


Deep MRD profiling defines outcome and unveils different modes of treatment resistance in standard- and high-risk myeloma.

Blood. 2021 Jan 7


652.Multiple Myeloma and Plasma cell Dyscrasias: Clinical and Epidemiological| November 5, 2021

Assessment of Treatment Response By Ife, Next Generation Flow Cytometry and Mass Spectrometry Coupled with Liquid Chromatography in the GEM2012MENOS65 Clinical Trial

Blood (2021) 138 (Supplement 1): 544.


FlowCT for the analysis of large immunophenotypic data sets and biomarker discovery in cancer immunology

Blood Adv; 2022 Jan


OAB-040 - BUMEL vs MEL-200 prior autologous transplant for patients with newly diagnosed multiple myeloma previously treated with bortezomib, lenalidomide and dexamethasone: final results of a phase 3 trial

#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California


SEPTEMBER 5 MARKS WORLD MULTIPLE MYELOMA DAY - GEM/PETHEMA moves towards the operational cure of multiple myeloma

Sep 5, 2022


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

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


Posts Archive
bottom of page