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GEM05 for Patients With Multiple Myeloma Under 65 Years
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
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| Phase III | Treatment | Active | 65 and under | 2005-001110-41
NCT00461747 |
Trial Description
Summary The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus Thalidomide/Velcade. Further Study Information A total of up to 390 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 (1:1:1) to receive VBMCP-VBAD+Velcade (Group A) or Thalidomide+Dexamethasone (Group B) or Thalidomide+Dexamethasone+Velcade (Group C). All of them will received the induction treatment up to 24 weeks. After 4 weeks, without progression or unacceptable toxicity, There will be stem cell mobilization to do an autologous transplant. Three months after transplant, patients will be again randomized (1:1:1) to receive maintenance treatment: Interferon-a (Group M1) or Thalidomide (Group M2) or Thalidomide+Velcade (Group M3) 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. Eligibility Criteria Inclusion Criteria: 1. Must be able to comply with the protocol requirements 2. Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care, 3. Age <65 years and possibly to do an autologous transplant. 4. Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma. 5. Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours. 6. ECOG < 2. 7. El patient has a life-expectancy > 3 months. 8. Patient has the following laboratory values before beginning induction treatment: 1. 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. 2. Corrected serum calcium <14mg/dl. 3. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. 4. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. 5. Total bilirubin: ≤1.5 x the upper limit of normal. 6. Serum creatinine ≤ 2 mg/dl. 9. For Patients included in Thalidomide branches: women of childbearing age must not have sex unless they use two anticonceptive methods beginning 4 weeks before the first dose, during all the study until 4 weeks after the last one. Exclusion Criteria: 1. Non-secretor Myeloma. 2. Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment. 3. Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment. 4. Patient had major surgery within 4 weeks before enrolment. 5. Patient has hypersensitivity to bortezomib, boron or mannitol or Thalidomide. 6. Patient has received other investigational drugs within 30 days before enrolment. 7. Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection. 8. 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. 9. Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason. 10. Pregnancy or breast-feed women.
Trial Contact Information
Trial Lead Organizations/Sponsors Program for the Study and Treatment of Hematological Malignancies | Bladé Joan, Dr | | Principal Investigator |
Trial Sites
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| Spain |
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Albacete |
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| | | | | | | | Hospital General de Albacete |
| | | Santiago José, Dr | Principal Investigator |
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Alcorcón |
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| | | Fundacion Hospital Alcorcon |
| | | Peñalver Francisco Javier, Dr | Principal Investigator |
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Alicante |
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| | | Hospital General - Alicante |
| | | Rivas Concepción, Dr | Principal Investigator |
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Avila |
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| | | Hospital Nuestra Senora de Sonsoles |
| | | Barez Abelardo, Dr | |
| | | Barez Abelardo, Dr | Principal Investigator |
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Badajoz |
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| | | Hospital Regional Universitario Infanta Cristina |
| | | Fuentes Inmaculada, Dr | Principal Investigator |
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Badalona |
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| | | Hospital Universitari Germans Trias i Pujol |
| | | Oriol Albert, DR | Principal Investigator |
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Barcelona |
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| | | Hospital Clinic de Barcelona |
| | | Blade Joan, Dr | Principal Investigator |
| | | Hospital de la Santa Cruz i Sant Pau |
| | | Sureda Anna, dr | Principal Investigator |
| | | Hospital Del Mar |
| | | Abella Eugenia, Dr | Principal Investigator |
| | | Vall d'Hebron University Hospital |
| | | Callis Manuel, Dr | Principal Investigator |
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Bilbao |
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| | | Hospital de Basurto |
| | | Beltran de Heredia José Mª, Dr | |
| | | Beltran de Heredia José Mª, Dr | Principal Investigator |
| | | Hospital de Cruces |
| | | García Juan Carlos, Dr | Principal Investigator |
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Cáceres |
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| | | Hospital Virgen del Puerto |
| | | Lopea Rosa, Dr | Principal Investigator |
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Castello |
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| | | Hospital General de Castellon |
| | | García Raimundo, Dr | |
| | | Garcia Raimundo, Dr | Principal Investigator |
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Ciudad Real |
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| | | Hospital Nuestra Senora de Alarcos |
| | | Hernández Belén, Dr | Principal Investigator |
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Cuenca |
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| | | Hospital General Virgen de la Luz |
| | | Guerra Jose Luis, Dr | Principal Investigator |
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Donostia |
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| | | Hospital Donostia |
| | | Bengoetxea Enrique, Dr | Principal Investigator |
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Elda |
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| | | Hospital General de Elda |
| | | Borrego Domingo, Dr | Principal Investigator |
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Getafe |
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| | | Hospital Universitario de Getafe |
| | | Somolinos Nieves, Dr | Principal Investigator |
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Guadalajara |
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| | | Hospital General Universitario De Guadalajara |
| | | Diaz Miguel, Dr | Principal Investigator |
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Huesca |
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| | | Hospital San Jorge |
| | | Puente Fernando | Principal Investigator |
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Lanzarote |
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| | | Hospital General de Lanzarote |
| | | Calvo José Manuel, Dr | Principal Investigator |
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Leon |
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| | | Complejo Hospitalario de Leon |
| | | Ramos Fernando, Dr | Principal Investigator |
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Lugo |
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| | | Hospital Xeral de Lugo |
| | | Arias Jesús, Dr | Principal Investigator |
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Madrid |
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| | | Clinica Moncloa |
| | | Perez Angeles, Dr | Principal Investigator |
| | | Clinica Puerta de Hierro |
| | | Krisnk Isabel, Dr | Principal Investigator |
| | | Fundacion Jimenez Diaz |
| | | Prieto Elena, Dr | Principal Investigator |
| | | Hospital Central de la Defensa |
| | | Montero Antonio, Dr | Principal Investigator |
| | | Hospital de la Princesa |
| | | Alegre Adrián, Dr | |
| | | Alegre Adrián, Dr | Principal Investigator |
| | | Hospital Ramon y Cajal |
| | | García Laraña José, Dr | Principal Investigator |
| | | Hospital Ruber Internacional |
| | | Martínez Carmen, Dr | Principal Investigator |
| | | Hospital Universitario 12 de Octubre |
| | | de la Serna Javier, Dr | Principal Investigator |
| | | Hospital Universitario La Paz |
| | | De Paz Raquel, Dr | Principal Investigator |
| | | Hospital Universitario San Carlos |
| | | Diaz Mediavilla Joaquin, Dr | |
| | | Díaz Mediavilla Joaquín, Dr | Principal Investigator |
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Manresa |
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| | | Althaia Xarxa Asistencial de Manresa |
| | | Subirà Maricel, Dr | Principal Investigator |
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Martorell |
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| | | Fundacio Hospital Sant Joan de Deu |
| | | Las Heras German, Dr | Principal Investigator |
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Mérida |
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| | | Hospital de Merida |
| | | Lopez Carlos, Dr | Principal Investigator |
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Murcia |
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| | | Hospital General Universitario Morales Meseguer |
| | | De Arriba Felipe, Dr | Principal Investigator |
| | | Hospital Santa Maria del Rosell |
| | | Ibañez Jerónima, Dr | Principal Investigator |
| | | Hospital Virgen del Castillo |
| | | Esteban Julio, Dr | Principal Investigator |
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Oviedo |
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| | | Hospital Universitario Central de Asturias |
| | | Rayón Consuelo, Dr | Principal Investigator |
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Palencia |
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| | | Hospital del Rio Carrion |
| | | Ortega Frenando, Dr | |
| | | Ortega Fernando, Dr | Principal Investigator |
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Palma de Gran Canaria |
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| | | Hospital de Gran Canaria Dr. Negrin |
| | | Suarez Alexia, Dr | Principal Investigator |
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Palma de Mallorca |
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| | | Hospital Son Dureta |
| | | Sampol Antonia | Principal Investigator |
| | | Hospital Son Llatzer |
| | | Bargay Joan, Dr | Principal Investigator |
| | | Hospital Verge del Toro |
| | | Galán Pilar, Dr | Principal Investigator |
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Pamplona |
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| | | Clinica Universitaria |
| | | Pérez Equiza Katy, dr | Principal Investigator |
| | | Prosper Felipe, Dr | |
| | | Prosper Felipe, Dr | Principal Investigator |
| | | Hospital Virgen del Camino |
| | | Goñi Mª Angeles, Dr | Principal Investigator |
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Pontevedra |
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| | | Complejo Hospitalario de Pontevedra |
| | | Allegue Mª José, Dr | Principal Investigator |
| | | Constela Manuel, Dr | Principal Investigator |
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Sabadell |
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| | | Hospital de Sabadell |
| | | Soler Alfonso, Dr | |
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Sagunto |
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| | | Hospital de Sagunto |
| | | Navarro Isabel, Dr | Principal Investigator |
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Salamanca |
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| | | University Hospital - Salamanca |
| | | Jesus F. San Miguel | Principal Investigator |
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San Pedro de Alcántara |
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| | | Hospital San Pedro de Alcantara |
| | | Martín Mª Luisa, Dr | Principal Investigator |
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Sant Pere de Ribes |
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| | | Hospital - Residencia Sant Camil |
| | | Asensio Antonio, Dr | Principal Investigator |
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Santander |
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| | | Hospital Universitario Marques de Valdecilla |
| | | E. Conde | Principal Investigator |
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Santiago de Compostela |
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| | | Santiago de Compostela University Hospital |
| | | Bello Jose Luis, Dr | Principal Investigator |
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Segovia |
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| | | Hospital General de Segovia |
| | | Hernández José Mariano | Principal Investigator |
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Tarragona |
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| | | Hospital Universitari de Tarragona Joan XXIII |
| | | Escoda Lourdes, Dr | |
| | | Escoda Lourdes | Principal Investigator |
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Tenerife |
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| | | Hospital Universitario de Canarias |
| | | Bernardo Gonzalez, Dr | Principal Investigator |
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Toledo |
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| | | Hospital Nuestra Senora del Prado |
| | | Solano Fernando, DR | Principal Investigator |
| | | Hospital Virgen de la Salud |
| | | Casado Luis Felipe, Dr | Principal Investigator |
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Valencia |
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| | | Hospital Arnau Vilanova |
| | | Lopez Aurelio, Dr | Principal Investigator |
| | | Hospital Clinico Universitario de Valencia |
| | | Terol Maria José, Dr | |
| | | Terol Mª José, Dr | Principal Investigator |
| | | Hospital Francesc de Borja |
| | | Ruiz Mª Angeles, Dr | Principal Investigator |
| | | Hospital General Basico de la Defensa |
| | | Cáceres Amparo, Dr | Principal Investigator |
| | | Hospital Universitario Dr. Peset |
| | | Sayas Mª José | Principal Investigator |
| | | Hospital Universitario La Fe |
| | | Sanz Miguel Angel, Dr | Principal Investigator |
| | | Instituto Valenciano De Oncologia |
| | | Llorente Pablo, Dr | Principal Investigator |
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Valladolid |
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| | | Universidad de Valladolid |
| | | Fernandez Calvo Francisco, Dr | Principal Investigator |
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Vigo |
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| | | Complejo Hospitalario Xeral de Vigo |
| | | Poderós Concepción, Dr | Principal Investigator |
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Vinaros |
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| | | Hospital Comarcal de Vinaros |
| | | Montagud Mario, Dr | Principal Investigator |
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Vitoria |
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| | | Hospital Txagorritxu |
| | | Guinea Josep Mª, Dr | |
| | | Guinea José Mª, Dr | Principal Investigator |
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Vizcaya |
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| | | Hospital de Galdakao |
| | | Ojanguren Jesús, Dr | Principal Investigator |
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Zamora |
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| | | Hospital Virgen de la Concha |
| | | Martín Alejandro, Dr | Principal Investigator |
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Zaragoza |
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| | | Hospital Clinico Universitario Lozano Blesa |
| | | Palomera Luis, Dr | |
| | | Palomera Luis, Dr | Principal Investigator |
| | | Hospital Royo Villanova |
| | | Lopez Luis, Dr | Principal Investigator |
| | | Hospital Universitario Miguel Servet |
| | | Rubio Araceli, Dr | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00461747
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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