GEM05 for Patients With Multiple Myeloma More Than 65 Years Old
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Older patients, untreated patients
Eligibility Criteria
Inclusion Criteria:
- Must be able to comply with the protocol requirements.
- Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care, with the understanding it can be withdrawn at any time without prejudice to future medical care.
- Age > 65 years.
- Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria28 and that has not received any previous chemotherapy treatment for Multiple Myeloma Some steroid doses or bisphosphonates are allowed for emergencies before starting induction treatment.
- Patient has measurable disease, defined as follows:
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.
- Patient has a ECOG performance status < 2
- Patient has a life-expectancy >3 months.
- Patient has the following laboratory values before beginning induction treatment:
Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed if they are due to marrow infiltration.
Corrected serum calcium <14mg/dl. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine ≤ 2 mg/dl.
Exclusion Criteria:
- Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates.
- Non-secretor Myeloma
- Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment.
- Patient had major surgery within 4 weeks before enrolment.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Patient has received other investigational drugs within 30 days before enrolment.
- Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.
- Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
Sites / Locations
- Hospital Royo Villanova
- Complejo Hospitalario Universitario de Albacete
- Fundación Hospital Alcorcón
- Hospital Nuestra Señora de Sonsoles
- Hospital Regional Universitario Infanta Cristina
- Hospital de Badalona Germans Trias i Pujol
- Hospital Clinic i Provincial de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital del Mar
- Hospital Vall D'Hebron
- Hospital de Basurto
- Hospital de Cruces
- Hospital General de Castellón
- Hospital Nuestra Señora de Alarcos
- Hospital Virgen de la Luz
- Hospital Virgen del Puerto
- Hospital Donostia
- Hospital General de Elda
- Institut Català d'Oncologia,
- Hospital Universitario de Getafe
- Hospital General de Guadalajara
- Hospital de San Jorge
- Hospital General de Lanzarote
- Complejo Hospitalario Xeral-Calde
- Clínica Moncloa
- Clínica Puerta de Hierro
- Clínica Rúber
- Fundación Jiménez Díaz
- Hospital Central de la Defensa
- Hospital Clínico Universitario San Carlos
- Hospital Doce de Octubre
- Hospital Ramón y Cajal
- Hospital Universitario La Paz
- Hospital Universitario La Princesa
- Althaia, Xarxa Asistencial de Manresa
- Fundación Hospital Sant Joan de Déu de Martorell
- Hospital General Morales Meseguer
- Hospital Santa María del Rosell
- Hospital Virgen del Castillo de Yecla
- Hospital de Mérida
- Hospital de Móstoles
- Hospital de Gran Canaria Doctor Negrín
- Complejo Asistencial Son Dureta
- Hospital Son Llatzer
- Hospital Verge del Toro
- Clínica Universitaria de Navarra
- Hospital de Navarra
- Hospital Virgen del Camino
- Complejo Hospitalario de Pontevedra_Hospital Montecelo
- Complejo Hospitalario de Pontevedra_Hospital Provincial
- Corporació Sanitaria Parc Taulí
- Hospital de Sagunto
- Hospital Clínico de Salamanca
- Hospital San Pedro de Alcántara
- Clínica Sant Camil
- Hospital Universitario Marqués de Valdecilla
- Complejo Hospitalario Universitario de Santiago
- Hospital General de Segovia
- Hospital Joan XXIII
- Hospital Universitario de Canarias
- Hospital Nuestra Señora del Prado
- Hospital Virgen de la Salud
- Fundación Instituto Valenciano de Oncología
- Hospital Arnau de Vilanova
- Hospital Clínico Universitario de Valencia
- Hospital Francesc de Borja
- Hospital General Básico de la Defensa
- Hospital Universitario La Fe
- Hospital Clínico Universitario de Valladolid
- Hospital Comarcal Pius de Valls
- Complejo Hospitalario Universitario de Vigo
- Comarcal de Vinaros
- Hospital Txagorritxu
- Hospital de Galdakao
- Hospital Virgen de la Concha
- Hospital Clínico Universitario Lozano Blesa
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
A
B
One cycle: Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)
One cycle: Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)