Back to resultsGEM05 for Patients With Multiple Myeloma Under 65 Years (GEM05MENOS65)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
VBMCP/VBAD/Velcade
Thalidomide/Dexamethasone
Velcade/Thalidomide/Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Untreated, Transplant, Younger
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,
- Age <65 years and possibly to do an autologous transplant.
- Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma.
- Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours.
- ECOG < 2.
- El 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.
- 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:
- Non-secretor Myeloma.
- Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment.
- 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 or Thalidomide.
- 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.
- Pregnancy or breast-feed women.
Sites / Locations
- Hospital Royo Villanova
- Xarxa assistencial de Manresa
- Corporació Sanitària Parc Taulí
- Hospital general de Castellón
- Clínica Universitaria de Navarra
- Complejo Hospitalario Universitario de Albacete
- Fundación Hospital Alcorcón
- Hospital General de Alicante
- Hospital Ntra. Sra. 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
- Basurtuko Ospitalea
- Hospital de Cruces
- Hospital Nuestra Señora de Alarcos
- Hospital Virgen de la Luz
- Hospital Virgen del Puerto
- Hospital Donostia
- Hospital General de Elda
- Hospital Universitario de Getafe
- Hospital General de Guadalajara
- Hospital de San Jorge
- Hospital General de Lanzarote
- Complejo Hospitalario León
- Complexo Hospitalario Xeral-Calde
- Clínica Moncloa
- Clínica Puerta de Hierro
- Clínica Rúber
- Fundación Jiménez Díaz
- Hospital 12 de Octubre
- Hospital Central de la Defensa
- Hospital Clínico San Carlos de Madrid
- Hospital Ramón y Cajal
- Hospital Universitario de la Princesa
- Hospital Universitario La Paz
- 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 Central de Asturias
- Hospital del Río Carrión
- Hospital de Gran Canaria Doctor Negrín
- Complejo Asistencial Son Dureta
- Hospital Son Llatzer
- Hospital Verge del Toro
- Hospital de Navarra
- Hospital Virgen del Camino
- Complejo Hospitalario de Pontevedra_Hospital Montecelo
- Complejo Hospitalario de Pontevedra_Hospital Provincial
- 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 Clínic
- Hospital Dr. Peset
- Hospital Francesc de Borja
- Hospital General Básico de la Defensa
- Hospital La Fe
- Hospital Clínico de Valladolid
- Complejo Hospitalario Universitario de Vigo
- Comarcal de Vinaros
- Hospital Txagorritxu
- Hospital de Galdakao
- Hospital Virgen de la Concha
- Hospital Clínico Lozano Blesa
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
A
B
C
Arm Description
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
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: 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.
Outcomes
Primary Outcome Measures
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 Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00461747
Brief Title
GEM05 for Patients With Multiple Myeloma Under 65 Years
Acronym
GEM05MENOS65
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 Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PETHEMA Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Untreated, Transplant, Younger
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
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
Arm Title
B
Arm Type
Experimental
Arm Description
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
Arm Title
C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VBMCP/VBAD/Velcade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Thalidomide/Dexamethasone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Velcade/Thalidomide/Dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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,
Age <65 years and possibly to do an autologous transplant.
Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma.
Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours.
ECOG < 2.
El 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.
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:
Non-secretor Myeloma.
Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment.
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 or Thalidomide.
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.
Pregnancy or breast-feed women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bladé Joan, Dr
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Royo Villanova
City
Zaragoza
State/Province
Aragón
Country
Spain
Facility Name
Xarxa assistencial de Manresa
City
Manresa
State/Province
Barcelona
Country
Spain
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Hospital general de Castellón
City
Castello
State/Province
Castellón
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Albacete
City
Albacete
Country
Spain
Facility Name
Fundación Hospital Alcorcón
City
Alcorcón
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Ntra. Sra. Sonsoles
City
Avila
Country
Spain
Facility Name
Hospital Regional Universitario Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
Hospital de Badalona Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Vall D'Hebron
City
Barcelona
Country
Spain
Facility Name
Basurtuko Ospitalea
City
Bilbao
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
Country
Spain
Facility Name
Hospital Nuestra Señora de Alarcos
City
Ciudad Real
Country
Spain
Facility Name
Hospital Virgen de la Luz
City
Cuenca
Country
Spain
Facility Name
Hospital Virgen del Puerto
City
Cáceres
Country
Spain
Facility Name
Hospital Donostia
City
Donostia
Country
Spain
Facility Name
Hospital General de Elda
City
Elda
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
Country
Spain
Facility Name
Hospital General de Guadalajara
City
Guadalajara
Country
Spain
Facility Name
Hospital de San Jorge
City
Huesca
Country
Spain
Facility Name
Hospital General de Lanzarote
City
Lanzarote
Country
Spain
Facility Name
Complejo Hospitalario León
City
Leon
Country
Spain
Facility Name
Complexo Hospitalario Xeral-Calde
City
Lugo
Country
Spain
Facility Name
Clínica Moncloa
City
Madrid
Country
Spain
Facility Name
Clínica Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Clínica Rúber
City
Madrid
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Central de la Defensa
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos de Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Fundación Hospital Sant Joan de Déu de Martorell
City
Martorell
Country
Spain
Facility Name
Hospital General Morales Meseguer
City
Murcia
Country
Spain
Facility Name
Hospital Santa María del Rosell
City
Murcia
Country
Spain
Facility Name
Hospital Virgen del Castillo de Yecla
City
Murcia
Country
Spain
Facility Name
Hospital de Mérida
City
Mérida
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital del Río Carrión
City
Palencia
Country
Spain
Facility Name
Hospital de Gran Canaria Doctor Negrín
City
Palma de Gran Canaria
Country
Spain
Facility Name
Complejo Asistencial Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Verge del Toro
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Virgen del Camino
City
Pamplona
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra_Hospital Montecelo
City
Pontevedra
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra_Hospital Provincial
City
Pontevedra
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
Country
Spain
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
San Pedro de Alcántara
Country
Spain
Facility Name
Clínica Sant Camil
City
Sant Pere de Ribes
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital General de Segovia
City
Segovia
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
Country
Spain
Facility Name
Hospital Nuestra Señora del Prado
City
Toledo
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Fundación Instituto Valenciano de Oncología
City
Valencia
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
Hospital Clínic
City
Valencia
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
Country
Spain
Facility Name
Hospital Francesc de Borja
City
Valencia
Country
Spain
Facility Name
Hospital General Básico de la Defensa
City
Valencia
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Clínico de Valladolid
City
Valladolid
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
Country
Spain
Facility Name
Comarcal de Vinaros
City
Vinaros
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
Country
Spain
Facility Name
Hospital de Galdakao
City
Vizcaya
Country
Spain
Facility Name
Hospital Virgen de la Concha
City
Zamora
Country
Spain
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
10735013
Citation
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PubMed Identifier
10761055
Citation
Oken MM. Management of Myeloma: Current and Future Approaches. Cancer Control. 1998 May;5(3):218-225. doi: 10.1177/107327489800500302.
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PubMed Identifier
5933438
Citation
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PubMed Identifier
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Citation
Alexanian R, Haut A, Khan AU, Lane M, McKelvey EM, Migliore PJ, Stuckey WJ Jr, Wilson HE. Treatment for multiple myeloma. Combination chemotherapy with different melphalan dose regimens. JAMA. 1969 Jun 2;208(9):1680-5. doi: 10.1001/jama.208.9.1680. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Salmon SE, Haut A, Bonnet JD, Amare M, Weick JK, Durie BG, Dixon DO. Alternating combination chemotherapy and levamisole improves survival in multiple myeloma: a Southwest Oncology Group Study. J Clin Oncol. 1983 Aug;1(8):453-61. doi: 10.1200/JCO.1983.1.8.453.
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PubMed Identifier
1999714
Citation
Boccadoro M, Marmont F, Tribalto M, Avvisati G, Andriani A, Barbui T, Cantonetti M, Carotenuto M, Comotti B, Dammacco F, et al. Multiple myeloma: VMCP/VBAP alternating combination chemotherapy is not superior to melphalan and prednisone even in high-risk patients. J Clin Oncol. 1991 Mar;9(3):444-8. doi: 10.1200/JCO.1991.9.3.444.
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PubMed Identifier
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Citation
MacLennan IC, Chapman C, Dunn J, Kelly K. Combined chemotherapy with ABCM versus melphalan for treatment of myelomatosis. The Medical Research Council Working Party for Leukaemia in Adults. Lancet. 1992 Jan 25;339(8787):200-5. doi: 10.1016/0140-6736(92)90004-m.
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Spanish association of Haematology
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GEM05 for Patients With Multiple Myeloma Under 65 Years
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