Pethema Multiple Myeloma 2000
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Alternating chemotherapy
Autologous Transplantation
Maintenance
Second transplantation
ALOGENIC MINI TRASPLANTATION
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Alternating chemotherapy, Transplantation
Eligibility Criteria
Inclusion Criteria:
- Less 70 years
- ECOG 0-2
- Symptomatic MM (pain, anemia, infection, haemorrhage, loss of weight, hypercalcemia, extramedulary plasmocytoma, creatinine >2 mg/dl).
- No previous chemotherapy
Exclusion Criteria:
- >70 years
- ECOG 3-4
- myeloma quiescent
- cardiopathy
- liver disfunction
- HIV+
- Hepatitis B-C +
- Previous chemotherapy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00560053
First Posted
November 15, 2007
Last Updated
November 26, 2008
Sponsor
PETHEMA Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00560053
Brief Title
Pethema Multiple Myeloma 2000
Official Title
Multiple Myeloma 2000. Multicentric Evaluation of a Therapeutic Strategy Optimized in Multiple Myeloma. Analysis of Efficiency and Possible Pronostic Impact of Minimal Residual Disease (Measured By PCR And Citometry of Flow) in Patients With Complete Response
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PETHEMA Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study objectives are to investigate the toxicity and the BUMEL response rate; in patients who reach the CR after autotransplantation, investigate if negativization of IF, influences in disease evolution; in patients in PR after autotransplantation, analyze if the second intensive procedure is capable of increasing the response rate and increasing the survival so that patients who reached the CR with the first transplantation; Patients with MM primarily resistant to the chemotherapy, investigate the efficacy of a double transplantation; patients submitted to double transplantation, control the efficacy of the second transplantation in front of allogenic transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Alternating chemotherapy, Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alternating chemotherapy
Intervention Description
4 cycles of alternating chemotherapy VBMCP/VBAD (every 5 weeks). VBMCP: Vcr 2 mg ev day 1, BCNU 0.5 mg/kg ev day 1, Cyclophosphamide 10 mg/kg day 1, Melphalan 0.25 mg/kg v.o. days 1-4, Prednisone 1 mg/kg v.o. days 1-4, 0.5 mg/kg days 5-8 and 0.25 mg/kg days 9-12.
VBAD: Vcr 1 mg e.v. day 1, BCNU 30 mg/m 2 e.v. day 1, Adriamycine 40 mg/m 2 day 1, Dexamethasone 40 mg/m 2 days 1-4, 9-12 and 17-20.
Intervention Type
Procedure
Intervention Name(s)
Autologous Transplantation
Intervention Description
Autologous Transplantation :
BUMEL:Busulfan, total dose 12 mg/kg (days -6 a -3; prophylaxis with difenilhidantoine) Melphalan 140 mg/m 2 , ev day -2 TASPE: To investigator criteria
Intervention Type
Drug
Intervention Name(s)
Maintenance
Intervention Description
At 3 months of transplantation or with >1.500 neutrophiles/ > 75.000 platelets mm 3 .
Prednisone: 50 mg alternating days during 2 years Interferon alfa 2-b: 3 M UI s.c. Three times a week until relapse.
Intervention Type
Procedure
Intervention Name(s)
Second transplantation
Intervention Description
In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .
Intervention Type
Procedure
Intervention Name(s)
ALOGENIC MINI TRASPLANTATION
Intervention Description
ALOGENIC MINI TRASPLANTATION Fludarabine 30 mg / m 2 / day, days -7, -6, -5, -4, -3 Melphalan 70 mg / m 2 / day, day -2 Prophylaxis EICH: CsA + MTX or CsA + MOFETIL
10. Eligibility
Sex
All
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Less 70 years
ECOG 0-2
Symptomatic MM (pain, anemia, infection, haemorrhage, loss of weight, hypercalcemia, extramedulary plasmocytoma, creatinine >2 mg/dl).
No previous chemotherapy
Exclusion Criteria:
>70 years
ECOG 3-4
myeloma quiescent
cardiopathy
liver disfunction
HIV+
Hepatitis B-C +
Previous chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Bladé, Dr
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juan Jose Lahuerta, Dr
Organizational Affiliation
Hospital Doce de Octubre Madrid
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adrián Alegre, Dr
Organizational Affiliation
Hospital La Princesa (Madrid)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna Sureda, Dr
Organizational Affiliation
Hospital Sant Pau Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joaquín Díaz Mediavilla, Dr
Organizational Affiliation
Hospital Clinico Madrid
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Javier De la Rubia, Dr
Organizational Affiliation
Hospital La Fe de Valencia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joan Bargay, Dr
Organizational Affiliation
Hospital Son Dureta Palma de Mallorca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose García-Laraña, Dr
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eulogio Conde, Dr
Organizational Affiliation
Hospital Valdecilla Santander
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Felipe Prosper, Dr
Organizational Affiliation
Hospital Clinico Valencia
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
24117042
Citation
Martinez-Lopez J, Fernandez-Redondo E, Garcia-Sanz R, Montalban MA, Martinez-Sanchez P, Pavia B, Mateos MV, Rosinol L, Martin M, Ayala R, Martinez R, Blanchard MJ, Alegre A, Besalduch J, Bargay J, Hernandez MT, Sarasquete ME, Sanchez-Godoy P, Fernandez M, Blade J, San Miguel JF, Lahuerta JJ; GEM (Grupo Espanol Multidisciplinar de Melanoma)/PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) cooperative study group. Clinical applicability and prognostic significance of molecular response assessed by fluorescent-PCR of immunoglobulin genes in multiple myeloma. Results from a GEM/PETHEMA study. Br J Haematol. 2013 Dec;163(5):581-9. doi: 10.1111/bjh.12576. Epub 2013 Oct 3.
Results Reference
derived
PubMed Identifier
22897964
Citation
Blanes M, Lahuerta JJ, Gonzalez JD, Ribas P, Solano C, Alegre A, Blade J, San Miguel JF, Sanz MA, de la Rubia J. Intravenous busulfan and melphalan as a conditioning regimen for autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: a matched comparison to a melphalan-only approach. Biol Blood Marrow Transplant. 2013 Jan;19(1):69-74. doi: 10.1016/j.bbmt.2012.08.009. Epub 2012 Aug 13.
Results Reference
derived
PubMed Identifier
22058223
Citation
Rosinol L, Garcia-Sanz R, Lahuerta JJ, Hernandez-Garcia M, Granell M, de la Rubia J, Oriol A, Hernandez-Ruiz B, Rayon C, Navarro I, Garcia-Ruiz JC, Besalduch J, Gardella S, Lopez Jimenez J, Diaz-Mediavilla J, Alegre A, San Miguel J, Blade J; PETHEMA/Spanish Myeloma Group. Benefit from autologous stem cell transplantation in primary refractory myeloma? Different outcomes in progressive versus stable disease. Haematologica. 2012 Apr;97(4):616-21. doi: 10.3324/haematol.2011.051441. Epub 2011 Nov 4.
Results Reference
derived
PubMed Identifier
20663944
Citation
Lahuerta JJ, Mateos MV, Martinez-Lopez J, Grande C, de la Rubia J, Rosinol L, Sureda A, Garcia-Larana J, Diaz-Mediavilla J, Hernandez-Garcia MT, Carrera D, Besalduch J, de Arriba F, Oriol A, Escoda L, Garcia-Frade J, Rivas-Gonzalez C, Alegre A, Blade J, San Miguel JF; Grupo Espanol de MM and Programa para el Estudio de la Terapeutica en Hemopatia Maligna Cooperative Study Groups. Busulfan 12 mg/kg plus melphalan 140 mg/m2 versus melphalan 200 mg/m2 as conditioning regimens for autologous transplantation in newly diagnosed multiple myeloma patients included in the PETHEMA/GEM2000 study. Haematologica. 2010 Nov;95(11):1913-20. doi: 10.3324/haematol.2010.028027. Epub 2010 Jul 27.
Results Reference
derived
PubMed Identifier
19880781
Citation
Paiva B, Vidriales MB, Perez JJ, Mateo G, Montalban MA, Mateos MV, Blade J, Lahuerta JJ, Orfao A, San Miguel JF; GEM (Grupo Espanol de MM) cooperative study group; PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) cooperative study group. Multiparameter flow cytometry quantification of bone marrow plasma cells at diagnosis provides more prognostic information than morphological assessment in myeloma patients. Haematologica. 2009 Nov;94(11):1599-602. doi: 10.3324/haematol.2009.009100.
Results Reference
derived
PubMed Identifier
19755674
Citation
Paiva B, Vidriales MB, Mateo G, Perez JJ, Montalban MA, Sureda A, Montejano L, Gutierrez NC, Garcia de Coca A, de las Heras N, Mateos MV, Lopez-Berges MC, Garcia-Boyero R, Galende J, Hernandez J, Palomera L, Carrera D, Martinez R, de la Rubia J, Martin A, Gonzalez Y, Blade J, Lahuerta JJ, Orfao A, San-Miguel JF; GEM (Grupo Espanol de MM)/PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) Cooperative Study Groups. The persistence of immunophenotypically normal residual bone marrow plasma cells at diagnosis identifies a good prognostic subgroup of symptomatic multiple myeloma patients. Blood. 2009 Nov 12;114(20):4369-72. doi: 10.1182/blood-2009-05-221689. Epub 2009 Sep 15.
Results Reference
derived
PubMed Identifier
18669875
Citation
Paiva B, Vidriales MB, Cervero J, Mateo G, Perez JJ, Montalban MA, Sureda A, Montejano L, Gutierrez NC, Garcia de Coca A, de Las Heras N, Mateos MV, Lopez-Berges MC, Garcia-Boyero R, Galende J, Hernandez J, Palomera L, Carrera D, Martinez R, de la Rubia J, Martin A, Blade J, Lahuerta JJ, Orfao A, San Miguel JF; GEM (Grupo Espanol de MM)/PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) Cooperative Study Groups. Multiparameter flow cytometric remission is the most relevant prognostic factor for multiple myeloma patients who undergo autologous stem cell transplantation. Blood. 2008 Nov 15;112(10):4017-23. doi: 10.1182/blood-2008-05-159624. Epub 2008 Jul 31.
Results Reference
derived
PubMed Identifier
18612103
Citation
Rosinol L, Perez-Simon JA, Sureda A, de la Rubia J, de Arriba F, Lahuerta JJ, Gonzalez JD, Diaz-Mediavilla J, Hernandez B, Garcia-Frade J, Carrera D, Leon A, Hernandez M, Abellan PF, Bergua JM, San Miguel J, Blade J; Programa para el Estudio y la Terapeutica de las Hemopatias Malignas y Grupo Espanol de Mieloma (PETHEMA/GEM). A prospective PETHEMA study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma. Blood. 2008 Nov 1;112(9):3591-3. doi: 10.1182/blood-2008-02-141598. Epub 2008 Jul 8.
Results Reference
derived
Links:
URL
http://aehh.org
Description
spanish hematology association
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Pethema Multiple Myeloma 2000
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