Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old (GEM2012MENOS65)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, MEL200, BUMEL
Eligibility Criteria
Inclusion Criteria:
- The patient must, in the opinion of the investigator, be capable of complying with all requirements of the trial
- 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:
- Non-secretory myeloma without measurable plasmacytomas.
- 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.
Sites / Locations
- Hospital Durán i Reynals - ICO L´Hospitalet
- H. Althaia, Xarxa Asistencial de Manresa
- Hospital Esp. de Jerez de la Frontera
- Hospital Son Espases (Son Dureta)
- Hospital Son Llátzer
- Hospital de Gran Canaria Dr. Negrín
- Hospital Nuestra Señora del Prado
- Complejo Universitario de Toledo
- Hospital General de Albacete
- Hospital Univ. Fundación de Alcorcón
- Hospital General Univ. de Alicante
- Hospital Torrevieja Salud UTE
- Hospital del Tajo
- Hospital German Trias i Pujol
- Hospital de Cruces
- Hospital Clinic i Provincial de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital del Mar
- Hospital Vall d´Hebrón
- Hospital Universitario de Burgos
- Hospital General Univ. Santa Lucía
- Hospital General de Castellón
- Hospital General de Ciudad Real
- Hospital San Pedro de Alcántara (Complejo Hospitalario de Cáceres)
- Hospital del Vinalopó
- Hospital de Fuenlabrada
- Hospital de Cabueñes
- H. Univ. de Girona Dr. Josep Trueta (ICO)
- Complejo Hosp. Virgen de las Nieves
- Hospital Universitario de Guadalajara
- Hospital Severo Ochoa
- Hospital de León
- Hospital Universitari Arnau de Vilanova de Lleida
- Hospital San Pedro
- Centro Oncológico MD Anderson
- Fundación Jiménez Díaz-UTE
- Hospital Clínico Universitario San Carlos
- Hospital General Univ. Gregorio Marañón
- Hospital Infanta Cristina
- Hospital Infanta Leonor
- Hospital Infanta Sofía
- Hospital Ramón y Cajal
- Hospital Universitario 12 de Octubre
- Hospital Universitario de la Princesa
- Hospital Universitario La Paz
- Hospital Universitario Madrid Sanchinarro
- Hospital Universitario Puerta de Hierro-Majadahonda
- Complejo Hospitalario Costa del Sol
- Hospital Morales Meseguer
- Hospital Universitario Virgen de la Arrixaca
- Complejo Hospitalario Ourense
- Hospital Universitario Central Asturias
- Clínica Universidad de Navarra
- Complejo Hospitalario de Navarra (Hospital Virgen del Camino)
- Complejo Hospitalario Pontevedra
- Hospital de Sabadell (Parc Taulí)
- Hospital Clínico de Salamanca
- Hospital Universitario de Donostia
- Hospital Univ. Marqués de
- Complejo Universitario de Santiago
- Hospital General de Segovia
- Complejo Hosp. Regional Virgen del Rocío
- Hospital Nuestra Señora de Valme
- Hospital Santa Bárbara
- H. Universitari de Tarragona Joan XXIII
- Hospital Universitari Mutua de Terrassa
- Hospital Clínico Universitario de Valencia
- Hospital Universitario Dr. Peset
- Hospital Universitario La Fe
- Hospital Clínico de Valladolid
- Hospital Universitario Río Hortega
- Hospital de Txagorritxu
- Hospital Clínico Universitario Lozano Blesa
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
MEL-200
BUMEL
bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by high-dose melphalan-200 (MEL-200)
bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by busulfan-melphalan (BUMEL) chemotherapy and consolidation with VRD-GEM