Clinical trial NCT00560053: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Alternating chemotherapy
Transplantation
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2007-11-19
Enrollment: 500
Sex: ALL
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Joan Bladé, Dr
role: STUDY_CHAIR
affiliation: Hospital Doce de Octubre Madrid
name: Juan Jose Lahuerta, Dr
role: STUDY_CHAIR
affiliation: Hospital La Princesa Madrid
name: Adrián Alegre, Dr
role: STUDY_CHAIR
affiliation: Hospital Sant Pau Barcelona
name: Anna Sureda, Dr
role: STUDY_CHAIR
affiliation: Hospital Clinico Madrid
name: Joaquín Díaz Mediavilla, Dr
role: STUDY_CHAIR
affiliation: Hospital La Fe de Valencia
name: Javier De la Rubia, Dr
role: STUDY_CHAIR
affiliation: Hospital Son Dureta Palma de Mallorca
name: Joan Bargay, Dr
role: STUDY_CHAIR
affiliation: Hospital Universitario Ramon y Cajal
name: Jose García-Laraña, Dr
role: STUDY_CHAIR
affiliation: Hospital Valdecilla Santander
name: Eulogio Conde, Dr
role: STUDY_CHAIR
affiliation: Hospital Clinico Valencia
name: Felipe Prosper, Dr
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.