GEM05 for Patients With Multiple Myeloma Under 65 Years
NCT ID: NCT00461747
Last Updated: 2009-09-18
Study Results
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Basic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2006-03-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Four alternating cycles of VBMCP/VBAD + Velcade VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalán, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.
VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20. The interval between VBMCP and VBAD is 5 weeks and between VBAD and VBMCP is 4 weeks. The patients will received two cycles of VBMCP and two cycles of VBAD. After 4 weeks of last cycle of VBAD, patients will received two cycles of Velcade, 1,3 mg/ m2 iv twice a week (days 1, 4, 8 and 11), followed by 10 days without treatment
VBMCP/VBAD/Velcade
VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalan, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.
VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20.
B
Six cycles of 4 weeks of Thalidomide/Dexamethasone. Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity \< grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.
Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days
Thalidomide/Dexamethasone
Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity \< grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.
Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days
C
Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is \< grade 2, the dose will be increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.
Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.
Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days.
Velcade/Thalidomide/Dexamethasone
Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is \< grade 2, the dose increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.
Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.
Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days
Interventions
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VBMCP/VBAD/Velcade
VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalan, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.
VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20.
Thalidomide/Dexamethasone
Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity \< grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.
Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days
Velcade/Thalidomide/Dexamethasone
Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is \< grade 2, the dose increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.
Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.
Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days
Eligibility Criteria
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Inclusion Criteria
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
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.
65 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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pethema
Principal Investigators
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Bladé Joan, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital San Pedro de Alcántara
San Pedro, , Spain
Clínica Sant Camil
Sant Pere de Ribes, , 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 General de Alicante
Alicante, Alicante, Spain
Hospital Royo Villanova
Zaragoza, Aragon, Spain
Hospital Ntra. Sra. Sonsoles
Ávila, Avila, Spain
Xarxa assistencial de Manresa
Manresa, Barcelona, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital general de Castellón
Castelló, Castellón, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Central de Asturias
Oviedo, Oviedo, Spain
Hospital del Río Carrión
Palencia, Palencia, Spain
Hospital Joan XXIII
Tarragona, Tarragona, Spain
Hospital Clínic
Valencia, Valencia, Spain
Hospital La Fe
Valencia, Valencia, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Fundación Hospital Alcorcón
Alcorcón, , 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 Virgen del Puerto
Cáceres, , Spain
Hospital Nuestra Señora de Alarcos
Ciudad Real, , Spain
Hospital Virgen de la Luz
Cuenca, , Spain
Hospital Donostia
Donostia / San Sebastian, , 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
León, , 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 Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Fundación Hospital Sant Joan de Déu de Martorell
Martorell, , Spain
Hospital de Mérida
Mérida, , Spain
Hospital General Morales Meseguer
Murcia, , Spain
Hospital Santa María del Rosell
Murcia, , Spain
Hospital Virgen del Castillo de Yecla
Murcia, , 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
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Hospital General de Segovia
Segovia, , 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 Dr. Peset
Valencia, , Spain
Hospital Francesc de Borja
Valencia, , Spain
Hospital General Básico de la Defensa
Valencia, , Spain
Hospital Clínico de Valladolid
Valladolid, , Spain
Complejo Hospitalario Universitario de Vigo
Vigo, , Spain
Comarcal de Vinaros
Vinaròs, , Spain
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
Hospital de Galdakao
Vizcaya, , Spain
Hospital Virgen de la Concha
Zamora, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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References
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Spanish association of Haematology
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2005-001110-41
Identifier Type: -
Identifier Source: org_study_id
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