QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression
NCT ID: NCT00480363
Last Updated: 2013-07-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-05-31
Study Completion Date
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM. The second one is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety and tolerability of the treatment
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients
NCT03001804
Multiple Myeloma
COMPLETED
GEM-CLARIDEX: Ld vs BiRd
NCT02575144
Multiple Myeloma
UNKNOWN
PHASE3
Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
NCT00689936
Multiple Myeloma
COMPLETED
PHASE3
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
NCT00420849
Multiple Myeloma
COMPLETED
PHASE3
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT07138209
Relapsed or Refractory Multiple Myeloma
NOT_YET_RECRUITING
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A total of up to 120 patients diagnosed of smoldering Multiple Myeloma with high risk of progression to symptomatic MM will be included.
Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive Revlimid and Dexamethasone (Group A) in 9 treatment cycles and maintenance with lower doses until progression or No treatment and observation until progression (Group B).
The 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 stratified and randomized (1:1) to Group A or Group B.
During Treatment Period patients will be evaluated once a month. Once the treatment period has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be carry out in Group A. During this period we will evaluate response, progression-free survival and global survival every two months.
Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive Revlimid and Dexamethasone (Group A) in 9 treatment cycles and maintenance with lower doses until progression or No treatment and observation until progression (Group B).
The 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 stratified and randomized (1:1) to Group A or Group B.
During Treatment Period patients will be evaluated once a month. Once the treatment period has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be carry out in Group A. During this period we will evaluate response, progression-free survival and global survival every two months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Multiple Myeloma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Lenalidomide + Dexamethasone for 9 cycles and maintenance
Group Type
EXPERIMENTAL
Maintenance with lower doses of lenalidomide and dexamethasone
Intervention Type
PROCEDURE
After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance
2
Observation
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Maintenance with lower doses of lenalidomide and dexamethasone
After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 ≥ 18 years
* Patient recently diagnosed with smoldering Multiple Myeloma with high risk of progression to symptomatic Multiple Myeloma defined as follows:
* Bone Marrow infiltration ≥ 10% CPs and M component Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein \> 1 g/dl and absence of: hollowed out areas of bone, Hypercalcemia (Calcium-serum \< 11.5 mg/dl), Renal Failure (creatinine \< 2 mg/dl) and anaemia (Hb \> 10 g/dl or at least 2g/dl under normal value.
* Alternatively, patients with Bone Marrow infiltration with CPs ≥ 10 %, or Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein \> 1 g/24h (but not the two of them together) and always without: lytic lesions, Hypercalcaemia, Renal Failure and Anaemia could be admitted with the following additional criteria:
* % CPs abnormal (CPa/CpcMO) ≥ 95 % with immunodeficiency, defined as diminution of levels of one or two Immunoglobulins of more than 25% respect normal values.
* ECOG \>= 2.
* The patient has to be able to complain with the protocol visits.
* Women of childbearing age must have a negative pregnancy test during the 14 days before first dose. And they must accept to use anticonceptive methods beginning during all the study until 4 weeks after the last one.
* Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care
* Age ≥ 18 years
* Patient recently diagnosed with smoldering Multiple Myeloma with high risk of progression to symptomatic Multiple Myeloma defined as follows:
* Bone Marrow infiltration ≥ 10% CPs and M component Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein \> 1 g/dl and absence of: hollowed out areas of bone, Hypercalcemia (Calcium-serum \< 11.5 mg/dl), Renal Failure (creatinine \< 2 mg/dl) and anaemia (Hb \> 10 g/dl or at least 2g/dl under normal value.
* Alternatively, patients with Bone Marrow infiltration with CPs ≥ 10 %, or Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein \> 1 g/24h (but not the two of them together) and always without: lytic lesions, Hypercalcaemia, Renal Failure and Anaemia could be admitted with the following additional criteria:
* % CPs abnormal (CPa/CpcMO) ≥ 95 % with immunodeficiency, defined as diminution of levels of one or two Immunoglobulins of more than 25% respect normal values.
* ECOG \>= 2.
* The patient has to be able to complain with the protocol visits.
* Women of childbearing age must have a negative pregnancy test during the 14 days before first dose. And they must accept to use anticonceptive methods beginning during all the study until 4 weeks after the last one.
Exclusion Criteria
* Any other organic or mental illness that could make impossible to sign the Inform consent.
* Patients previously received treatment to smoldering Multiple Myeloma.
* Pregnancy or breast-feed women
* Hollowed out areas of bone, anaemia, renal failure and Hypercalcemia
* The following laboratory data:
* Absolute neutrophil count ≥ 1000/mm3
* Platelet count ≥ 75000/mm3
* Aspartate transaminase (AST) or Alanine transaminase (ALT ) ≤ 3 x the upper limit of normal.
* Total bilirubin: ≤ 2 x the upper limit of normal.
* Patients with \>= Grade 2 peripheral neuropathy within 14 days before enrolment.
* Patient with a previous clinical history of another malignant illness except for squamous cell carcinoma or skin cancer or cervical cancer except the patient could be free of symptoms during ≥ 5 years.
* Patient has hypersensitivity or adverse events previous to lenalidomide or Dexamethasone.
* Patient who has major surgery during the 4th weeks previous inclusion.
* Patient has received other investigational drugs within 30 days before enrolment.
* Patients previously received treatment to smoldering Multiple Myeloma.
* Pregnancy or breast-feed women
* Hollowed out areas of bone, anaemia, renal failure and Hypercalcemia
* The following laboratory data:
* Absolute neutrophil count ≥ 1000/mm3
* Platelet count ≥ 75000/mm3
* Aspartate transaminase (AST) or Alanine transaminase (ALT ) ≤ 3 x the upper limit of normal.
* Total bilirubin: ≤ 2 x the upper limit of normal.
* Patients with \>= Grade 2 peripheral neuropathy within 14 days before enrolment.
* Patient with a previous clinical history of another malignant illness except for squamous cell carcinoma or skin cancer or cervical cancer except the patient could be free of symptoms during ≥ 5 years.
* Patient has hypersensitivity or adverse events previous to lenalidomide or Dexamethasone.
* Patient who has major surgery during the 4th weeks previous inclusion.
* Patient has received other investigational drugs within 30 days before enrolment.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene Corporation
INDUSTRY
Sponsor Role
collaborator
PETHEMA Foundation
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pethema
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mª Victoria Mateos, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico Universitario de Salamanca
Jesús San Miguel, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario de Salamanca
Joan Bladé, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Juan José Lahuerta, Dr
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL DOCE DE OCTUBRE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital germans Trias i Pujol
Badalona, , Spain
Site Status
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Site Status
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
Hospital del SAS de Jerez de la Frontera
Jerez de la Frontera, , Spain
Site Status
Hospital de la Princesa
Madrid, , Spain
Site Status
Hospital Dode de Octubre
Madrid, , Spain
Site Status
Hospital Ramón y Cajal
Madrid, , Spain
Site Status
Hospital General Univeristario Morales Messeguer
Murcia, , Spain
Site Status
Hospital Clínico de Salamanca
Salamanca, , Spain
Site Status
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Site Status
Hospital Clínico de Valencia
Valencia, , Spain
Site Status
Hospital Universitario la Fe
Valencia, , Spain
Site Status
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Spain
References
Explore related publications, articles, or registry entries linked to this study.
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
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Dimopoulos MA, Moulopoulos LA, Maniatis A, Alexanian R. Solitary plasmacytoma of bone and asymptomatic multiple myeloma. Blood. 2000 Sep 15;96(6):2037-44.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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)
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.aehh.org
Spanish association of Haematology
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QUIREDEX
Identifier Type: -
Identifier Source: secondary_id
2007-000649-36
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma
NCT00306813
COMPLETED
PHASE1/PHASE2
Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma
NCT02537808
COMPLETED
Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma
NCT01019174
COMPLETED
PHASE1/PHASE2
Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma
NCT02692339
COMPLETED
Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)
NCT01936532
COMPLETED
PHASE2
A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma
NCT00915408
COMPLETED
PHASE1/PHASE2
A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
NCT00478777
COMPLETED
PHASE3
Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
NCT01359657
COMPLETED
PHASE1
Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans
NCT03601624
UNKNOWN
PHASE2
Study of Bendamustine, Lenalidomide and Low-dose Dexamethasone, for the Treatment of Patients With Relapsed Myeloma
NCT01686386
UNKNOWN
PHASE1/PHASE2
Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure
NCT01084837
COMPLETED
PHASE2
Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma
NCT01090089
COMPLETED
PHASE3
Combination of Revlimid, Melphalan and Dexamethasone as First Line Treatment for Multiple Myeloma
NCT00843310
TERMINATED
PHASE2
Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma
NCT01701076
COMPLETED
PHASE2
Trial Studying Maintenance Treatment With Lenalidomide and Dexamethasone Versus Lenalidomide, Dexamethasone and MLN9708 After Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly-diagnosed Symptomatic Multiple Myeloma
NCT02406144
COMPLETED
PHASE3
Lenalidomide & High Dose Dexamethasone for Untreated Multiple Myeloma Renal Failure Patients
NCT01270932
COMPLETED
PHASE2
Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
NCT01632826
APPROVED_FOR_MARKETING
Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy
NCT01501370
WITHDRAWN
PHASE2
IFM2009-02-Pomalidomide and Dexamethasone Phase 2 Myeloma
NCT01053949
COMPLETED
PHASE2
Carfilzomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in High- Risk SMM
NCT03673826
ACTIVE_NOT_RECRUITING
PHASE2
Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
NCT00907452
COMPLETED
NA
Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
NCT00555100
COMPLETED
PHASE1