GEM05 for Patients With Multiple Myeloma More Than 65 Years Old
- Conditions
- Multiple Myeloma
- Interventions
- Drug: Melphalan/Prednisone/VelcadeDrug: Thalidomide/Prednisone/Velcade
- Registration Number
- NCT00443235
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments
- Detailed Description
A total of up to 260 patients \> 65 years old diagnosed of Multiple Myeloma with symptomatic disease and that have not received previous chemotherapy for MM will be included.
Patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.
The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility and then Patients will be randomized one to one to receive Melphalan+Prednisone+Velcade (Group A) or Thalidomide+Prednisone+Velcade (Group B). All of them will received the induction treatment up to 30 weeks. After 4 weeks, without progression and unacceptable toxicity, Patients will be again randomized one to one to receive maintenance treatment: Thalidomide+Velcade (Group M1) or Prednisone+Velcade (Group M2) during three years.
Once the treatment period has finished a follow up will be carry out. During this period we will evaluated response, progression-free survival and global survival every three months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- 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before performance of any study-related procedure not part of normal medical care, with the understanding it can be withdrawn at any time without prejudice to future medical care.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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Melphalan/Prednisone/Velcade 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) B Thalidomide/Prednisone/Velcade 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)
- Primary Outcome Measures
Name Time Method The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
Hospital de Gran Canaria Doctor Negrín
🇪🇸Palma de Gran Canaria, Spain
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Hospital Virgen de la Luz
🇪🇸Cuenca, Spain
Hospital Virgen del Puerto
🇪🇸Cáceres, Spain
Hospital de Basurto
🇪🇸Basurto, Spain
Hospital General de Castellón
🇪🇸Castellón, Spain
Clínica Moncloa
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Donostia
🇪🇸Donostia, Spain
Hospital General de Guadalajara
🇪🇸Guadalajara, Spain
Hospital Virgen del Castillo de Yecla
🇪🇸Murcia, Spain
Althaia, Xarxa Asistencial de Manresa
🇪🇸Manresa, Spain
Hospital Nuestra Señora de Sonsoles
🇪🇸Avila, Spain
Hospital Royo Villanova
🇪🇸Zaragoza, Aragón, Spain
Hospital de Badalona Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Regional Universitario Infanta Cristina
🇪🇸Badajoz, Spain
Hospital General de Elda
🇪🇸Elda, Spain
Hospital de San Jorge
🇪🇸Huesca, Spain
Hospital Santa María del Rosell
🇪🇸Murcia, Spain
Institut Català d'Oncologia,
🇪🇸Gerona, Spain
Complejo Hospitalario Xeral-Calde
🇪🇸Lugo, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Clínica Sant Camil
🇪🇸Sant Pere de Ribes, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Complejo Hospitalario de Pontevedra_Hospital Provincial
🇪🇸Pontevedra, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital Virgen de la Concha
🇪🇸Zamora, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Nuestra Señora de Alarcos
🇪🇸Ciudad Real, Spain
Hospital General de Lanzarote
🇪🇸Lanzarote, Spain
Clínica Puerta de Hierro
🇪🇸Madrid, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital General Morales Meseguer
🇪🇸Murcia, Spain
Fundación Hospital Sant Joan de Déu de Martorell
🇪🇸Martorell, Spain
Complejo Asistencial Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital de Mérida
🇪🇸Mérida, Spain
Hospital de Móstoles
🇪🇸Móstoles, Spain
Hospital Verge del Toro
🇪🇸Palma de Mallorca, Spain
Complejo Hospitalario de Pontevedra_Hospital Montecelo
🇪🇸Pontevedra, Spain
Corporació Sanitaria Parc Taulí
🇪🇸Sabadell, Spain
Hospital de Sagunto
🇪🇸Sagunto, Spain
Hospital Clínico de Salamanca
🇪🇸Salamanca, Spain
Hospital de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen del Camino
🇪🇸Pamplona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Hospital Nuestra Señora del Prado
🇪🇸Toledo, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Fundación Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Francesc de Borja
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital de Galdakao
🇪🇸Vizcaya, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Fundación Hospital Alcorcón
🇪🇸Alcorcón, Spain
Hospital Universitario de Getafe
🇪🇸Getafe, Spain
Hospital de Cruces
🇪🇸Bilbao, Spain
Clínica Rúber
🇪🇸Madrid, Spain
Hospital Central de la Defensa
🇪🇸Madrid, Spain
Hospital Clínico Universitario San Carlos
🇪🇸Madrid, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Spain
Hospital San Pedro de Alcántara
🇪🇸San Pedro de Alcántara, Spain
Comarcal de Vinaros
🇪🇸Vinaros, Spain
Hospital Comarcal Pius de Valls
🇪🇸Valls, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital General Básico de la Defensa
🇪🇸Valencia, Spain