GEM05 for Patients With Multiple Myeloma More Than 65 Years Old

NCT ID: NCT00443235

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-12-31

Brief Summary

The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments

Detailed Description

A total of up to 260 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 one to one to receive Melphalan+Prednisone+Velcade (Group A) or Thalidomide+Prednisone+Velcade (Group B). All of them will received the induction treatment up to 30 weeks. After 4 weeks, without progression and unacceptable toxicity, Patients will be again randomized one to one to receive maintenance treatment: Thalidomide+Velcade (Group M1) or Prednisone+Velcade (Group M2) 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

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

One cycle:

Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)

Group Type: ACTIVE_COMPARATOR

Melphalan/Prednisone/Velcade

Intervention Type: DRUG

One cycle:

Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)

B

One cycle:

Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)

Five cycles:

Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)

Group Type: EXPERIMENTAL

Thalidomide/Prednisone/Velcade

Intervention Type: DRUG

One cycle:

Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)

Five cycles:

Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)

Interventions

Melphalan/Prednisone/Velcade

One cycle:

Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)

Intervention Type: DRUG

Thalidomide/Prednisone/Velcade

One cycle:

Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)

Five cycles:

Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)

Intervention Type: DRUG

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, with the understanding it can be withdrawn at any time without prejudice to future medical care.
• Age > 65 years.
• Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria28 and that has not received any previous chemotherapy treatment for Multiple Myeloma Some steroid doses or bisphosphonates are allowed for emergencies before starting induction treatment.
• Patient has measurable disease, defined as follows:

For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.

• Patient has a ECOG performance status < 2
• 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.

Exclusion Criteria

• Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates.
• Non-secretor Myeloma
• 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.
• 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.

• Minimum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PETHEMA Foundation

OTHER

Sponsor Role: lead

Responsible Party

pethema

Principal Investigators

Lahuerta Juan josé, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre

Locations

Hospital Royo Villanova

Zaragoza, Aragon, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Fundación Hospital Alcorcón

Alcorcón, , Spain

Hospital Nuestra Señora de Sonsoles

Ávila, , 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

Hospital de Basurto

Basurto, , Spain

Hospital de Cruces

Bilbao, , Spain

Hospital General de Castellón

Castellon, , 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

Institut Català d'Oncologia,

Girona, , Spain

Hospital General de Guadalajara

Guadalajara, , Spain

Hospital de San Jorge

Huesca, , Spain

Hospital General de Lanzarote

Lanzarote, , Spain

Complejo 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 Central de la Defensa

Madrid, , Spain

Hospital Clínico Universitario San Carlos

Madrid, , Spain

Hospital Doce de Octubre

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Althaia, Xarxa Asistencial de Manresa

Manresa, , Spain

Fundación Hospital Sant Joan de Déu de Martorell

Martorell, , Spain

Hospital de Mérida

Mérida, , Spain

Hospital de Móstoles

Móstoles, , 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

Clínica Universitaria de Navarra

Pamplona, , 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

Corporació Sanitaria Parc Taulí

Sabadell, , Spain

Hospital de Sagunto

Sagunto, , Spain

Hospital Clínico de Salamanca

Salamanca, , Spain

Hospital San Pedro de Alcántara

San Pedro, , Spain

Clínica Sant Camil

Sant Pere de Ribes, , 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 Joan XXIII

Tarragona, , 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 Clínico Universitario de Valencia

Valencia, , Spain

Hospital Francesc de Borja

Valencia, , Spain

Hospital General Básico de la Defensa

Valencia, , Spain

Hospital Universitario La Fe

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Comarcal Pius de Valls

Valls, , 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 Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.

Reference Type: BACKGROUND

PMID: 10735013 (View on PubMed)

2. Longo D. Plasma cell disorders. In : Fauce A, et al. Ed. Harrison's Principles of Internal Medicine. 14th Ed. New York, New York: Mc Graw-Hill; 1998: 712-718.

Reference Type: BACKGROUND

Raje N, Anderson K. Thalidomide--a revival story. N Engl J Med. 1999 Nov 18;341(21):1606-9. doi: 10.1056/NEJM199911183412110. No abstract available.

Reference Type: BACKGROUND

PMID: 10564693 (View on PubMed)

Holland JR, Hosley H, Scharlau C, Carbone PP, Frei E 3rd, Brindley CO, Hall TC, Shnider BI, Gold GL, Lasagna L, Owens AH Jr, Miller SP. A controlled trial of urethane treatment in multiple myeloma. Blood. 1966 Mar;27(3):328-42. No abstract available.

Reference Type: BACKGROUND

PMID: 5933438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 5818682 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6366141 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1999714 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1346171 (View on PubMed)

Oken MM, Harrington DP, Abramson N, Kyle RA, Knospe W, Glick JH. Comparison of melphalan and prednisone with vincristine, carmustine, melphalan, cyclophosphamide, and prednisone in the treatment of multiple myeloma: results of Eastern Cooperative Oncology Group Study E2479. Cancer. 1997 Apr 15;79(8):1561-7.

Reference Type: BACKGROUND

PMID: 9118039 (View on PubMed)

Blade J, San Miguel JF, Alcala A, Maldonado J, Sanz MA, Garcia-Conde J, Moro MJ, Alonso C, Besalduch J, Zubizarreta A, et al. Alternating combination VCMP/VBAP chemotherapy versus melphalan/prednisone in the treatment of multiple myeloma: a randomized multicentric study of 487 patients. J Clin Oncol. 1993 Jun;11(6):1165-71. doi: 10.1200/JCO.1993.11.6.1165.

Reference Type: BACKGROUND

PMID: 8501503 (View on PubMed)

Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.

Reference Type: BACKGROUND

PMID: 9850028 (View on PubMed)

Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, Rajkumar SV, Srkalovic G, Alsina M, Alexanian R, Siegel D, Orlowski RZ, Kuter D, Limentani SA, Lee S, Hideshima T, Esseltine DL, Kauffman M, Adams J, Schenkein DP, Anderson KC. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003 Jun 26;348(26):2609-17. doi: 10.1056/NEJMoa030288.

Reference Type: BACKGROUND

PMID: 12826635 (View on PubMed)

Jagannath S, Barlogie B, Berenson J, Siegel D, Irwin D, Richardson PG, Niesvizky R, Alexanian R, Limentani SA, Alsina M, Adams J, Kauffman M, Esseltine DL, Schenkein DP, Anderson KC. A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol. 2004 Oct;127(2):165-72. doi: 10.1111/j.1365-2141.2004.05188.x.

Reference Type: BACKGROUND

PMID: 15461622 (View on PubMed)

14. Paul Richardson et al. Bortezomib Demonstrates Superior Efficacy to High-Dose Dexamethasone in Relapsed Multiple Myeloma: Final Report of the APEX Study. Blood 2004; 104(11):Abstract number 336.5

Reference Type: BACKGROUND

Rajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23. doi: 10.1200/JCO.2002.02.116.

Reference Type: BACKGROUND

PMID: 12409330 (View on PubMed)

Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9. doi: 10.1200/JCO.2003.03.139.

Reference Type: BACKGROUND

PMID: 12506164 (View on PubMed)

Rajkumar SV. Thalidomide in newly diagnosed multiple myeloma and overview of experience in smoldering/indolent disease. Semin Hematol. 2003 Oct;40(4 Suppl 4):17-22. doi: 10.1053/j.seminhematol.2003.09.007.

Reference Type: BACKGROUND

PMID: 15015892 (View on PubMed)

18. Antonio Palumbo, Alessandra Bertola, Pellegrino Musto, Tommaso Caravita, Vincenzo Callea, Clotilde Cangialosi, Anna Marina Liberati, Pasquale Niscola, Lucio Catalano, Mariella Grasso, Vito Michele Lauta, Maria Concetta Petti, Sergio Morandi, Monica Galli, Sara Bringhen, Federica Cavallo, Patrizia Falco, Mario Boccadoro. A Prospective Randomized Trial of Oral Melphalan, Prednisone, Thalidomide (MPT) vs Oral Melphalan, Prednisone (MP): An Interim Analysis. Blood 2004. Volume 104, issue 11.Abstract number 207

Reference Type: BACKGROUND

19. Maurizio Zangari, Bart Barlogie, Joth Jacobson, Erik Rasmussen, Michael Burns, Bob Kordsmeier, John D. Shaughnessy, Elias J. Anaissie, Raymond Thertulien, Athanasios Fassas, Choon-Kee Lee, David Schenkein, Jerome B. Zeldis, Guido Tricot. VTD Regimen Comprising Velcade (V) + Thalidomide (T) and Added DEX (D) for Non-Responders to V + T Effects a 57% PR Rate among 56 Patients with Myeloma (M) Relapsing after Autologous Transplant. Blood 2003, Volume 102, issue 11. Abstract number 830

Reference Type: BACKGROUND

20. Jagannath S, Brian D, Wolf j, Camacho E, Irwin D, Lutzky J, Mckinley M, Gabayan E, Mazumder A, Crowley K, Sckenkein D. A phase 2 study of Bortezomib as first-line therapy in patients with multiple myeloma. Blood 2004; 104(11). Abstract number 333

Reference Type: BACKGROUND

21. Alexanian R, Wang L, Weber D, Delasalle K. VTD (Velcade, Thalidomide, Dexamethasone) as primary therapy for newly-diagnosed multiple myeloma. Blood 2004; 104(11). Abstract number 210

Reference Type: BACKGROUND

Mateos MV, Hernandez JM, Hernandez MT, Gutierrez NC, Palomera L, Fuertes M, Diaz-Mediavilla J, Lahuerta JJ, de la Rubia J, Terol MJ, Sureda A, Bargay J, Ribas P, de Arriba F, Alegre A, Oriol A, Carrera D, Garcia-Larana J, Garcia-Sanz R, Blade J, Prosper F, Mateo G, Esseltine DL, van de Velde H, San Miguel JF. Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study. Blood. 2006 Oct 1;108(7):2165-72. doi: 10.1182/blood-2006-04-019778. Epub 2006 Jun 13.

Reference Type: BACKGROUND

PMID: 16772605 (View on PubMed)

Whealthy K (On behalf of the Myeloma Trialists'Collaborative Group). Which myeloma patients benefit from interferon therapy?. An overview of 24 randomised trials with 4,000 patients, Br J Haematol 1998; 102: 140

Reference Type: BACKGROUND

Blade J, Esteve J. Viewpoint on the impact of interferon in the treatment of multiple myeloma: benefit for a small proportion of patients? Med Oncol. 2000 May;17(2):77-84. doi: 10.1007/BF02796202.

Reference Type: BACKGROUND

PMID: 10871813 (View on PubMed)

Palumbo A, Boccadoro M, Garino LA, Gallone G, Frieri R, Pileri A. Multiple myeloma: intensified maintenance therapy with recombinant interferon-alpha-2b plus glucocorticoids. Eur J Haematol. 1992 Aug;49(2):93-7. doi: 10.1111/j.1600-0609.1992.tb00037.x.

Reference Type: BACKGROUND

PMID: 1397246 (View on PubMed)

Salmon SE, Crowley JJ, Balcerzak SP, Roach RW, Taylor SA, Rivkin SE, Samlowski W. Interferon versus interferon plus prednisone remission maintenance therapy for multiple myeloma: a Southwest Oncology Group Study. J Clin Oncol. 1998 Mar;16(3):890-6. doi: 10.1200/JCO.1998.16.3.890.

Reference Type: BACKGROUND

PMID: 9508170 (View on PubMed)

Berenson JR, Crowley JJ, Grogan TM, Zangmeister J, Briggs AD, Mills GM, Barlogie B, Salmon SE. Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients. Blood. 2002 May 1;99(9):3163-8. doi: 10.1182/blood.v99.9.3163.

Reference Type: BACKGROUND

PMID: 11964279 (View on PubMed)

International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. Br J Haematol. 2003 Jun;121(5):749-57.

Reference Type: BACKGROUND

PMID: 12780789 (View on PubMed)

Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. doi: 10.1046/j.1365-2141.1998.00930.x. No abstract available.

Reference Type: BACKGROUND

PMID: 9753033 (View on PubMed)

Rizzo JD, Lichtin AE, Woolf SH, Seidenfeld J, Bennett CL, Cella D, Djulbegovic B, Goode MJ, Jakubowski AA, Lee SJ, Miller CB, Rarick MU, Regan DH, Browman GP, Gordon MS; American Society of Clinical Oncology; Americcan Society of Hematology. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. Blood. 2002 Oct 1;100(7):2303-20. doi: 10.1182/blood-2002-06-1767.

Reference Type: BACKGROUND

PMID: 12239138 (View on PubMed)

Rizzo JD, Lichtin AE, Woolf SH, Seidenfeld J, Bennett CL, Cella D, Djulbegovic B, Goode MJ, Jakubowski AA, Lee SJ, Miller CB, Rarick MU, Regan DH, Browman GP, Gordon MS; American Society of Clinical Oncology. American Society of Hematology. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. J Clin Oncol. 2002 Oct 1;20(19):4083-107. doi: 10.1200/JCO.2002.07.177.

Reference Type: BACKGROUND

PMID: 12351606 (View on PubMed)

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

Reference Type: BACKGROUND

PMID: 8433390 (View on PubMed)

33. Fayers P, Aaonson N, Bjordal K, Curran D, Groenvold M, on behalf of the EORTC Quality of life study group. EORTC QLQ-C30 Scoring Manual: 2nd Ed. 1999. ISBN 2-930064-16-1.1

Reference Type: BACKGROUND

Stead ML, Brown JM, Velikova G, Kaasa S, Wisloff F, Child JA, Hippe E, Hjorth M, Sezer O, Selby P. Development of an EORTC questionnaire module to be used in health-related quality-of-life assessment for patients with multiple myeloma. European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Br J Haematol. 1999 Mar;104(3):605-11. doi: 10.1046/j.1365-2141.1999.01206.x.

Reference Type: BACKGROUND

PMID: 10086801 (View on PubMed)

Mateos MV, Oriol A, Martinez-Lopez J, Teruel AI, Bengoechea E, Palomera L, de Arriba F, Esseltine DL, Cakana A, Pei L, van de Velde H, Miguel JS. Outcomes with two different schedules of bortezomib, melphalan, and prednisone (VMP) for previously untreated multiple myeloma: matched pair analysis using long-term follow-up data from the phase 3 VISTA and PETHEMA/GEM05 trials. Ann Hematol. 2016 Dec;95(12):2033-2041. doi: 10.1007/s00277-016-2835-3. Epub 2016 Oct 14.

Reference Type: DERIVED

PMID: 27738789 (View on PubMed)

Mateos MV, Martinez-Lopez J, Hernandez MT, Ocio EM, Rosinol L, Martinez R, Teruel AI, Gutierrez NC, Martin Ramos ML, Oriol A, Bargay J, Bengoechea E, Gonzalez Y, Perez de Oteyza J, Gironella M, Encinas C, Martin J, Cabrera C, Paiva B, Cedena MT, Puig N, Blade J, Lahuerta JJ, San-Miguel J. Sequential vs alternating administration of VMP and Rd in elderly patients with newly diagnosed MM. Blood. 2016 Jan 28;127(4):420-5. doi: 10.1182/blood-2015-08-666537. Epub 2015 Oct 23.

Reference Type: DERIVED

PMID: 26500339 (View on PubMed)

Mateos MV, Oriol A, Martinez-Lopez J, Teruel AI, Lopez de la Guia A, Lopez J, Bengoechea E, Perez M, Martinez R, Palomera L, de Arriba F, Gonzalez Y, Hernandez JM, Granell M, Bello JL, Bargay J, Penalver FJ, Martin-Mateos ML, Paiva B, Montalban MA, Blade J, Lahuerta JJ, San-Miguel JF. GEM2005 trial update comparing VMP/VTP as induction in elderly multiple myeloma patients: do we still need alkylators? Blood. 2014 Sep 18;124(12):1887-93. doi: 10.1182/blood-2014-05-573733.

Reference Type: DERIVED

PMID: 25102853 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24117042 (View on PubMed)

Mateos MV, Oriol A, Martinez-Lopez J, Gutierrez N, Teruel AI, Lopez de la Guia A, Lopez J, Bengoechea E, Perez M, Polo M, Palomera L, de Arriba F, Gonzalez Y, Hernandez JM, Granell M, Bello JL, Bargay J, Penalver FJ, Ribera JM, Martin-Mateos ML, Garcia-Sanz R, Lahuerta JJ, Blade J, San-Miguel JF. Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial. Blood. 2012 Sep 27;120(13):2581-8. doi: 10.1182/blood-2012-05-427815. Epub 2012 Aug 13.

Reference Type: DERIVED

PMID: 22889759 (View on PubMed)

Lopez-Corral L, Mateos MV, Corchete LA, Sarasquete ME, de la Rubia J, de Arriba F, Lahuerta JJ, Garcia-Sanz R, San Miguel JF, Gutierrez NC. Genomic analysis of high-risk smoldering multiple myeloma. Haematologica. 2012 Sep;97(9):1439-43. doi: 10.3324/haematol.2011.060780. Epub 2012 Feb 13.

Reference Type: DERIVED

PMID: 22331267 (View on PubMed)

Mateos MV, Gutierrez NC, Martin-Ramos ML, Paiva B, Montalban MA, Oriol A, Martinez-Lopez J, Teruel AI, Bengoechea E, Martin A, Diaz-Mediavilla J, de Arriba F, Palomera L, Hernandez JM, Sureda A, Bargay J, Penalver FJ, Ribera JM, Martin-Mateos ML, Fernandez M, Garcia-Sanz R, Vidriales MB, Blade J, Lahuerta JJ, San Miguel JF. Outcome according to cytogenetic abnormalities and DNA ploidy in myeloma patients receiving short induction with weekly bortezomib followed by maintenance. Blood. 2011 Oct 27;118(17):4547-53. doi: 10.1182/blood-2011-04-345801. Epub 2011 Sep 6.

Reference Type: DERIVED

PMID: 21900193 (View on PubMed)

Sarasquete ME, Gutierrez NC, Misiewicz-Krzeminska I, Paiva B, Chillon MC, Alcoceba M, Garcia-Sanz R, Hernandez JM, Gonzalez M, San-Miguel JF. Upregulation of Dicer is more frequent in monoclonal gammopathies of undetermined significance than in multiple myeloma patients and is associated with longer survival in symptomatic myeloma patients. Haematologica. 2011 Mar;96(3):468-71. doi: 10.3324/haematol.2010.033845. Epub 2010 Dec 15.

Reference Type: DERIVED

PMID: 21160068 (View on PubMed)

Mateos MV, Oriol A, Martinez-Lopez J, Gutierrez N, Teruel AI, de Paz R, Garcia-Larana J, Bengoechea E, Martin A, Mediavilla JD, Palomera L, de Arriba F, Gonzalez Y, Hernandez JM, Sureda A, Bello JL, Bargay J, Penalver FJ, Ribera JM, Martin-Mateos ML, Garcia-Sanz R, Cibeira MT, Ramos ML, Vidriales MB, Paiva B, Montalban MA, Lahuerta JJ, Blade J, Miguel JF. Bortezomib, melphalan, and prednisone versus bortezomib, thalidomide, and prednisone as induction therapy followed by maintenance treatment with bortezomib and thalidomide versus bortezomib and prednisone in elderly patients with untreated multiple myeloma: a randomised trial. Lancet Oncol. 2010 Oct;11(10):934-41. doi: 10.1016/S1470-2045(10)70187-X. Epub 2010 Aug 23.

Reference Type: DERIVED

PMID: 20739218 (View on PubMed)

Related Links

http://www.aehh.org

Spanish association of Haematology

Other Identifiers

2005-001111-21

Identifier Type: -

Identifier Source: org_study_id