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GEM05 for Patients With Multiple Myeloma Under 65 Years

Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: VBMCP/VBAD/Velcade (Drug); Thalidomide/Dexamethasone (Drug); Velcade/Thalidomide/Dexamethasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
Bladé Joan, Dr, Principal Investigator, Affiliation: Hospital Clinic of Barcelona

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.

Clinical Details

Official title: A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.

Secondary outcome: 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

Detailed description: 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

Minimum age: N/A. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Complejo Hospitalario Universitario de Albacete, Albacete, Spain

Fundación Hospital Alcorcón, Alcorcón, Spain

Hospital General de Alicante, Alicante, Spain

Hospital Ntra. Sra. Sonsoles, Avila, Spain

Hospital Regional Universitario Infanta Cristina, Badajoz, Spain

Hospital de Badalona Germans Trias i Pujol, Badalona, 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'Hebron, Barcelona, Spain

Basurtuko Ospitalea, Bilbao, Spain

Hospital de Cruces, Bilbao, Spain

Hospital Nuestra Señora de Alarcos, Ciudad Real, Spain

Hospital Virgen de la Luz, Cuenca, Spain

Hospital Virgen del Puerto, Cáceres, Spain

Hospital Donostia, Donostia, Spain

Hospital General de Elda, Elda, Spain

Hospital Universitario de Getafe, Getafe, Spain

Hospital General de Guadalajara, Guadalajara, Spain

Hospital de San Jorge, Huesca, Spain

Hospital General de Lanzarote, Lanzarote, Spain

Complejo Hospitalario León, Leon, Spain

Complexo Hospitalario Xeral-Calde, Lugo, Spain

Clínica Moncloa, Madrid, Spain

Clínica Puerta de Hierro, Madrid, Spain

Clínica Rúber, Madrid, Spain

Fundación Jiménez Díaz, Madrid, Spain

Hospital 12 de Octubre, Madrid, Spain

Hospital Central de la Defensa, Madrid, Spain

Hospital Clínico San Carlos de Madrid, Madrid, Spain

Hospital Ramón y Cajal, Madrid, Spain

Hospital Universitario de la Princesa, Madrid, Spain

Hospital Universitario La Paz, Madrid, Spain

Fundación Hospital Sant Joan de Déu de Martorell, Martorell, Spain

Hospital General Morales Meseguer, Murcia, Spain

Hospital Santa María del Rosell, Murcia, Spain

Hospital Virgen del Castillo de Yecla, Murcia, Spain

Hospital de Mérida, Mérida, Spain

Hospital Central de Asturias, Oviedo, Spain

Hospital del Río Carrión, Palencia, Spain

Hospital de Gran Canaria Doctor Negrín, Palma de Gran Canaria, Spain

Complejo Asistencial Son Dureta, Palma de Mallorca, Spain

Hospital Son Llatzer, Palma de Mallorca, Spain

Hospital Verge del Toro, Palma de Mallorca, Spain

Hospital de Navarra, Pamplona, Spain

Hospital Virgen del Camino, Pamplona, Spain

Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, Spain

Complejo Hospitalario de Pontevedra_Hospital Provincial, Pontevedra, Spain

Hospital de Sagunto, Sagunto, Spain

Hospital Clínico de Salamanca, Salamanca, Spain

Hospital San Pedro de Alcántara, San Pedro de Alcántara, Spain

Clínica Sant Camil, Sant Pere de Ribes, Spain

Hospital Universitario Marqués de Valdecilla, Santander, Spain

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain

Hospital General de Segovia, Segovia, Spain

Hospital Joan XXIII, Tarragona, Spain

Hospital Universitario de Canarias, Tenerife, Spain

Hospital Nuestra Señora del Prado, Toledo, Spain

Hospital Virgen de la Salud, Toledo, Spain

Fundación Instituto Valenciano de Oncología, Valencia, Spain

Hospital Arnau de Vilanova, Valencia, Spain

Hospital Clínic, Valencia, Spain

Hospital Dr. Peset, Valencia, Spain

Hospital Francesc de Borja, Valencia, Spain

Hospital General Básico de la Defensa, Valencia, Spain

Hospital La Fe, Valencia, Spain

Hospital Clínico de Valladolid, Valladolid, Spain

Complejo Hospitalario Universitario de Vigo, Vigo, Spain

Comarcal de Vinaros, Vinaros, Spain

Hospital Txagorritxu, Vitoria, Spain

Hospital de Galdakao, Vizcaya, Spain

Hospital Virgen de la Concha, Zamora, Spain

Hospital Clínico Lozano Blesa, Zaragoza, Spain

Hospital Miguel Servet, Zaragoza, Spain

Hospital Royo Villanova, Zaragoza, Aragón, Spain

Xarxa assistencial de Manresa, Manresa, Barcelona, Spain

Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain

Hospital general de Castellón, Castello, Castellón, Spain

Clínica Universitaria de Navarra, Pamplona, Navarra, Spain

Additional Information

Spanish association of Haematology

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Starting date: March 2006
Last updated: September 17, 2009

Page last updated: August 23, 2015

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