QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression (QUIREDEX)

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ClinicalTrials.gov Identifier: NCT00480363

Recruitment Status : Completed

First Posted : May 30, 2007

Last Update Posted : July 31, 2013

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Celgene Corporation

Information provided by:

PETHEMA Foundation

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	July 2013

Publications:

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.

Dimopoulos MA, Moulopoulos A, Smith T, Delasalle KB, Alexanian R. Risk of disease progression in asymptomatic multiple myeloma. Am J Med. 1993 Jan;94(1):57-61. doi: 10.1016/0002-9343(93)90120-e.

Rajkumar SV. MGUS and smoldering multiple myeloma: update on pathogenesis, natural history, and management. Hematology Am Soc Hematol Educ Program. 2005:340-5. doi: 10.1182/asheducation-2005.1.340.

Wisloff F, Andersen P, Andersson TR, Brandt E, Eika C, Fjaestad K, Ly B, Lovasen K, Strom BR, Tjonnfjord GE. Has the incidence of multiple myeloma in old age been underestimated? The myeloma project of health region I in Norway. I. Eur J Haematol. 1991 Nov;47(5):333-7. doi: 10.1111/j.1600-0609.1991.tb01856.x.

Weber DM, Dimopoulos MA, Moulopoulos LA, Delasalle KB, Smith T, Alexanian R. Prognostic features of asymptomatic multiple myeloma. Br J Haematol. 1997 Jun;97(4):810-4. doi: 10.1046/j.1365-2141.1997.1122939.x.

Cesana C, Klersy C, Barbarano L, Nosari AM, Crugnola M, Pungolino E, Gargantini L, Granata S, Valentini M, Morra E. Prognostic factors for malignant transformation in monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. J Clin Oncol. 2002 Mar 15;20(6):1625-34. doi: 10.1200/JCO.2002.20.6.1625.

Dimopoulos MA, Moulopoulos LA, Maniatis A, Alexanian R. Solitary plasmacytoma of bone and asymptomatic multiple myeloma. Blood. 2000 Sep 15;96(6):2037-44.

Rosinol L, Blade J, Esteve J, Aymerich M, Rozman M, Montoto S, Gine E, Nadal E, Filella X, Queralt R, Carrio A, Montserrat E. Smoldering multiple myeloma: natural history and recognition of an evolving type. Br J Haematol. 2003 Nov;123(4):631-6. doi: 10.1046/j.1365-2141.2003.04654.x.

Moulopoulos LA, Dimopoulos MA, Smith TL, Weber DM, Delasalle KB, Libshitz HI, Alexanian R. Prognostic significance of magnetic resonance imaging in patients with asymptomatic multiple myeloma. J Clin Oncol. 1995 Jan;13(1):251-6. doi: 10.1200/JCO.1995.13.1.251.

Perez-Persona E, Vidriales MB, Mateo G, Garcia-Sanz R, Mateos MV, de Coca AG, Galende J, Martin-Nunez G, Alonso JM, de Las Heras N, Hernandez JM, Martin A, Lopez-Berges C, Orfao A, San Miguel JF. New criteria to identify risk of progression in monoclonal gammopathy of uncertain significance and smoldering multiple myeloma based on multiparameter flow cytometry analysis of bone marrow plasma cells. Blood. 2007 Oct 1;110(7):2586-92. doi: 10.1182/blood-2007-05-088443. Epub 2007 Jun 18.

Hjorth M, Hellquist L, Holmberg E, Magnusson B, Rodjer S, Westin J. Initial versus deferred melphalan-prednisone therapy for asymptomatic multiple myeloma stage I--a randomized study. Myeloma Group of Western Sweden. Eur J Haematol. 1993 Feb;50(2):95-102. doi: 10.1111/j.1600-0609.1993.tb00148.x.

Rajkumar SV, Gertz MA, Lacy MQ, Dispenzieri A, Fonseca R, Geyer SM, Iturria N, Kumar S, Lust JA, Kyle RA, Greipp PR, Witzig TE. Thalidomide as initial therapy for early-stage myeloma. Leukemia. 2003 Apr;17(4):775-9. doi: 10.1038/sj.leu.2402866.

D'Amato RJ, Loughnan MS, Flynn E, Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):4082-5. doi: 10.1073/pnas.91.9.4082.

Geitz H, Handt S, Zwingenberger K. Thalidomide selectively modulates the density of cell surface molecules involved in the adhesion cascade. Immunopharmacology. 1996 Mar;31(2-3):213-21. doi: 10.1016/0162-3109(95)00050-x.

Haslett PA, Corral LG, Albert M, Kaplan G. Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytotoxic responses in the CD8+ subset. J Exp Med. 1998 Jun 1;187(11):1885-92. doi: 10.1084/jem.187.11.1885.

Corral LG, Haslett PA, Muller GW, Chen R, Wong LM, Ocampo CJ, Patterson RT, Stirling DI, Kaplan G. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999 Jul 1;163(1):380-6.

Parman T, Wiley MJ, Wells PG. Free radical-mediated oxidative DNA damage in the mechanism of thalidomide teratogenicity. Nat Med. 1999 May;5(5):582-5. doi: 10.1038/8466.

Davies FE, Raje N, Hideshima T, Lentzsch S, Young G, Tai YT, Lin B, Podar K, Gupta D, Chauhan D, Treon SP, Richardson PG, Schlossman RL, Morgan GJ, Muller GW, Stirling DI, Anderson KC. Thalidomide and immunomodulatory derivatives augment natural killer cell cytotoxicity in multiple myeloma. Blood. 2001 Jul 1;98(1):210-6. doi: 10.1182/blood.v98.1.210.

Richardson PG, Schlossman RL, Weller E, Hideshima T, Mitsiades C, Davies F, LeBlanc R, Catley LP, Doss D, Kelly K, McKenney M, Mechlowicz J, Freeman A, Deocampo R, Rich R, Ryoo JJ, Chauhan D, Balinski K, Zeldis J, Anderson KC. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood. 2002 Nov 1;100(9):3063-7. doi: 10.1182/blood-2002-03-0996.

20. Zangari M, Tricot G, Zeldis J, et al. Results of phase I study of CC-5013 for the treatment of multiple myeloma patients who relapse after high dose chemotherapy (HDCT). Blood 2001; 98:775a (Abstract 3226)

Richardson PG, Blood E, Mitsiades CS, Jagannath S, Zeldenrust SR, Alsina M, Schlossman RL, Rajkumar SV, Desikan KR, Hideshima T, Munshi NC, Kelly-Colson K, Doss D, McKenney ML, Gorelik S, Warren D, Freeman A, Rich R, Wu A, Olesnyckyj M, Wride K, Dalton WS, Zeldis J, Knight R, Weller E, Anderson KC. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood. 2006 Nov 15;108(10):3458-64. doi: 10.1182/blood-2006-04-015909. Epub 2006 Jul 13.

23. Baz R, Choueiri TK, Jawde RA, et al. Doxil (D), Vincristine (V), Reduced Frequency Dexamethasone (d) and Revlimid(R) (DVd-R) Results in a High Response Rate in Patients with Refractory Multiple Myeloma(RMM).Blood 2005; 106: 2559.

Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, Rajkumar SV, Hideshima T, Xiao H, Esseltine D, Schenkein D, Anderson KC; SUMMIT Investigators. Clinical factors predictive of outcome with bortezomib in patients with relapsed, refractory multiple myeloma. Blood. 2005 Nov 1;106(9):2977-81. doi: 10.1182/blood-2005-02-0691. Epub 2005 Jul 14.

Rajkumar SV, Hayman SR, Lacy MQ, Dispenzieri A, Geyer SM, Kabat B, Zeldenrust SR, Kumar S, Greipp PR, Fonseca R, Lust JA, Russell SJ, Kyle RA, Witzig TE, Gertz MA. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood. 2005 Dec 15;106(13):4050-3. doi: 10.1182/blood-2005-07-2817. Epub 2005 Aug 23.

Desikan R, Barlogie B, Sawyer J, Ayers D, Tricot G, Badros A, Zangari M, Munshi NC, Anaissie E, Spoon D, Siegel D, Jagannath S, Vesole D, Epstein J, Shaughnessy J, Fassas A, Lim S, Roberson P, Crowley J. Results of high-dose therapy for 1000 patients with multiple myeloma: durable complete remissions and superior survival in the absence of chromosome 13 abnormalities. Blood. 2000 Jun 15;95(12):4008-10.

27. Palumbo A, Falco P, Musto P, et al. Oral RevlimidR Plus Melphalan and Prednisone (R-MP) for Newly Diagnosed Multiple Myeloma. Blood 2005; 106: 785.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mateos MV, Hernandez MT, Salvador C, Rubia J, de Arriba F, Lopez-Corral L, Rosinol L, Paiva B, Palomera L, Bargay J, Oriol A, Prosper F, Lopez J, Arguinano JM, Blade J, Lahuerta JJ, San-Miguel J. Lenalidomide-dexamethasone versus observation in high-risk smoldering myeloma after 12 years of median follow-up time: A randomized, open-label study. Eur J Cancer. 2022 Oct;174:243-250. doi: 10.1016/j.ejca.2022.07.030. Epub 2022 Sep 5.

Mateos MV, Hernandez MT, Giraldo P, de la Rubia J, de Arriba F, Corral LL, Rosinol L, Paiva B, Palomera L, Bargay J, Oriol A, Prosper F, Lopez J, Arguinano JM, Quintana N, Garcia JL, Blade J, Lahuerta JJ, Miguel JS. Lenalidomide plus dexamethasone versus observation in patients with high-risk smouldering multiple myeloma (QuiRedex): long-term follow-up of a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1127-1136. doi: 10.1016/S1470-2045(16)30124-3. Epub 2016 Jul 9.

Paiva B, Mateos MV, Sanchez-Abarca LI, Puig N, Vidriales MB, Lopez-Corral L, Corchete LA, Hernandez MT, Bargay J, de Arriba F, de la Rubia J, Teruel AI, Giraldo P, Rosinol L, Prosper F, Oriol A, Hernandez J, Esteves G, Lahuerta JJ, Blade J, Perez-Simon JA, San Miguel JF; Spanish Myeloma Group / Program Study and Treatment of Hematological Malignancies cooperative study groups. Immune status of high-risk smoldering multiple myeloma patients and its therapeutic modulation under LenDex: a longitudinal analysis. Blood. 2016 Mar 3;127(9):1151-62. doi: 10.1182/blood-2015-10-662320. Epub 2015 Dec 14.

Mateos MV, Hernandez MT, Giraldo P, de la Rubia J, de Arriba F, Lopez Corral L, Rosinol L, Paiva B, Palomera L, Bargay J, Oriol A, Prosper F, Lopez J, Olavarria E, Quintana N, Garcia JL, Blade J, Lahuerta JJ, San Miguel JF. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013 Aug 1;369(5):438-47. doi: 10.1056/NEJMoa1300439.

Matarraz S, Paiva B, Diez-Campelo M, Lopez-Corral L, Perez E, Mateos MV, Giraldo P, Hernandez MT, San Miguel JF, Orfao A; GEM Grupo Espanol de MM/Programa para el Estudio de la Terapeutica en Hemopatias Malignas Co-operative Study Groups. Myelodysplasia-associated immunophenotypic alterations of bone marrow cells in myeloma: are they present at diagnosis or are they induced by lenalidomide? Haematologica. 2012 Oct;97(10):1608-11. doi: 10.3324/haematol.2012.064121. Epub 2012 Apr 17.

Weiss BM, Kuehl WM. Advances in understanding monoclonal gammopathy of undetermined significance as a precursor of multiple myeloma. Expert Rev Hematol. 2010 Apr;3(2):165-74. doi: 10.1586/ehm.10.13.

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