Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old
NCT ID: NCT01916252
Last Updated: 2017-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2013-09-30
2016-11-16
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MEL-200
bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by high-dose melphalan-200 (MEL-200)
bortezomib (Velcade ®)
lenalidomide (Revlimid®)
Dexamethasone acetate
Melphalan
BUMEL
bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by busulfan-melphalan (BUMEL) chemotherapy and consolidation with VRD-GEM
bortezomib (Velcade ®)
lenalidomide (Revlimid®)
busulfan (Busilvex ®)
Dexamethasone acetate
Melphalan
Interventions
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bortezomib (Velcade ®)
lenalidomide (Revlimid®)
busulfan (Busilvex ®)
Dexamethasone acetate
Melphalan
Eligibility Criteria
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Inclusion Criteria
* Have signed the informed consent form
* Be between 18 and 65 years of age and a candidate for autologous stem cell transplant
* Have an ECOG Performance Status \> 2 (or 3 if the ECOG is due to myeloma)
* Newly diagnosed patient with symptomatic multiple myeloma based on standard criteria, who has not received any prior chemotherapy treatment for Multiple Myeloma.
* Patient must have measurable disease, defined by the following criteria:
For secretory MM, measurable disease is defined by any quantifiable value of serum M-protein (IgG ≥ 10 g/L or IgA \> 5 g/L) and/or, when applicable, an excretion of light chain in urine ≥ 200 mg/24 hours.
For oglio- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas, which is determined by clinical exam or radiographic techniques.
* Life expectancy \> 3 months.
* The patient must have the following laboratory values in the 21 days prior to initiation of treatment (day 1, cycle 1):
Platelet count ≥ 100 x 109/L and absolute neutrophil count of ≥ 1.0 x 109/L Corrected serum calcium \< 14 mg/dL. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x the upper limit of normal (ULN).
Total bilirubin within normal limits. Serum creatinine ≤ 2 mg/dL
\- Women of childbearing potential and men (including vasectomized men whose partners are women of childbearing potential), must use two methods of contraception during the entire course of treatment, during dose interruptions and for up to three months after receiving the final dose
Exclusion Criteria
* Patients who have undergone prior treatment for multiple myeloma, with the exception of emergency treatment using steroid pulses, bisphosphonates, or radiotherapy received before beginning induction treatment.
* Peripheral neuropathy ≥ grade 2 in the 21 days prior to inclusion.
* Known hypersensitivity to bortezomib, boric acid, mannitol or lenalidomide.
* Patients that have received any investigational agent in the 28 days prior to inclusion in the study.
* Patients who have had a myocardial infarction in the six months prior to inclusion in this study or who are a class III or IV according to the New York Heart Association (NYHA) functional classification system, heart failure, unstable angina, uncontrolled ventricular arrhythmias or acute ischemia detected by electrocardiogram, or nervous system disorders.
* Patients currently enrolled in another clinical trial or receiving any type of investigational agent.
* Patients who are seropositive for HBV, HCV or HIV.
18 Years
65 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Celgene
INDUSTRY
Pierre Fabre Medicament
INDUSTRY
PETHEMA Foundation
OTHER
Responsible Party
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Locations
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Hospital Son Espases (Son Dureta)
Mallorca, Balearic Islands, Spain
Hospital Son Llátzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Durán i Reynals - ICO L´Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
H. Althaia, Xarxa Asistencial de Manresa
Manresa, Barcelona, Spain
Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Esp. de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Nuestra Señora del Prado
Talavera de La Reina, Madrid, Spain
Complejo Universitario de Toledo
Toledo, Madrid, Spain
Hospital General de Albacete
Albacete, , Spain
Hospital Univ. Fundación de Alcorcón
Alcorcón, , Spain
Hospital General Univ. de Alicante
Alicante, , Spain
Hospital Torrevieja Salud UTE
Alicante, , Spain
Hospital del Tajo
Aranjuez, , Spain
Hospital German Trias i Pujol
Badalona, , Spain
Hospital de Cruces
Barakaldo, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Vall d´Hebrón
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital General Univ. Santa Lucía
Cartagena, , Spain
Hospital General de Castellón
Castellon, , Spain
Hospital San Pedro de Alcántara (Complejo Hospitalario de Cáceres)
Cáceres, , Spain
Hospital General de Ciudad Real
Ciudad Real, , Spain
Hospital del Vinalopó
Elche, , Spain
Hospital de Fuenlabrada
Fuenlabrada, , Spain
Hospital de Cabueñes
Gijón, , Spain
H. Univ. de Girona Dr. Josep Trueta (ICO)
Girona, , Spain
Complejo Hosp. Virgen de las Nieves
Granada, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Hospital Severo Ochoa
Leganés, , Spain
Hospital de León
León, , Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, , Spain
Hospital San Pedro
Logroño, , Spain
Centro Oncológico MD Anderson
Madrid, , Spain
Fundación Jiménez Díaz-UTE
Madrid, , Spain
Hospital Clínico Universitario San Carlos
Madrid, , Spain
Hospital General Univ. Gregorio Marañón
Madrid, , Spain
Hospital Infanta Cristina
Madrid, , Spain
Hospital Infanta Leonor
Madrid, , Spain
Hospital Infanta Sofía
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, , Spain
Complejo Hospitalario Costa del Sol
Marbella, , Spain
Hospital Morales Meseguer
Murcia, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Complejo Hospitalario Ourense
Ourense, , Spain
Hospital Universitario Central Asturias
Oviedo, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Complejo Hospitalario de Navarra (Hospital Virgen del Camino)
Pamplona, , Spain
Complejo Hospitalario Pontevedra
Pontevedra, , Spain
Hospital de Sabadell (Parc Taulí)
Sabadell, , Spain
Hospital Clínico de Salamanca
Salamanca, , Spain
Hospital Universitario de Donostia
San Sebastián, , Spain
Hospital Univ. Marqués de
Santander, , Spain
Complejo Universitario de Santiago
Santiago de Compostela, , Spain
Hospital General de Segovia
Segovia, , Spain
Complejo Hosp. Regional Virgen del Rocío
Seville, , Spain
Hospital Nuestra Señora de Valme
Seville, , Spain
Hospital Santa Bárbara
Soria, , Spain
H. Universitari de Tarragona Joan XXIII
Tarragona, , Spain
Hospital Universitari Mutua de Terrassa
Terrassa, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clínico de Valladolid
Valladolid, , Spain
Hospital Universitario Río Hortega
Valladolid, , Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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References
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Lahuerta JJ, San-Miguel J, Jimenez-Ubieto A, Alonso R, Paiva B, Puig N, Cedena MT, Gutierrez NC, Calasanz MJ, Fernandez Guijarro M, Tamayo RR, Rocafiguera AO, Blanchard MJ, Carrillo Cruz E, Martinez-Martinez R, Bargay J, Sureda Balari A, Rubia J, Hernandez Garcia MT, Cabanas V, Montero FC, Bernal LP, Montes YG, Martinez-Lopez J, Rodriguez-Otero P, Krisnik I, Arguinano JM, Gonzalez Garcia ME, Ocio EM, Cruz J, Mateos MV, Rosinol L, Blade J. High-dose busulfan-melphalan vs melphalan and reinforced VRD for newly diagnosed multiple myeloma: a phase 3 GEM trial. Blood. 2025 Oct 9;146(15):1747-1758. doi: 10.1182/blood.2025028313.
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Lakhwani S, Rosinol L, Puig N, Pico-Picos MA, Medina-Gonzalez L, Martinez-Lopez J, Paiva B, Cedena MT, Oriol A, Rios-Tamayo R, Blanchard MJ, Jarque I, Bargay J, Moraleda JM, Carrillo-Cruz E, Sureda A, Krsnik I, Gonzalez E, Casado LF, Marti JM, Encinas C, De Arriba F, Palomera L, Sampol A, Gonzalez-Montes Y, Motllo C, De La Cruz J, Alonso R, Mateos MV, Blade J, Lahuerta JJ, San-Miguel J, Hernandez MT. Recovery of uninvolved heavy/light chain pair immunoparesis in newly diagnosed transplant-eligible myeloma patients complements the prognostic value of minimal residual disease detection. Haematologica. 2024 Jun 1;109(6):1909-1917. doi: 10.3324/haematol.2023.284154.
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Cardona-Benavides IJ, Misiewicz-Krzeminska I, Rojas EA, De Ramon C, Sanz-Solas A, Isidro I, Quwaider D, Lopez-Guerrero AM, Cuadrado M, Calasanz MJ, Rosinol L, Martinez-Lopez J, San Miguel JF, Mateos MV, Corchete LA, Gutierrez NC. Quantification of cyclin D1 and D2 proteins in multiple myeloma identifies different expression patterns from those revealed by gene expression profiling. Haematologica. 2024 Mar 1;109(3):877-887. doi: 10.3324/haematol.2023.283445.
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Other Identifiers
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GEM2012MENOS65
Identifier Type: -
Identifier Source: org_study_id