Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
FIRST
A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
2 other identifiers
interventional
1,623
18 countries
277
Brief Summary
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Aug 2008
Typical duration for phase_3 multiple-myeloma
277 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedStudy Start
First participant enrolled
August 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2016
CompletedResults Posted
Study results publicly available
August 11, 2017
CompletedNovember 20, 2019
November 1, 2019
7.9 years
June 2, 2008
July 13, 2017
November 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
Secondary Outcomes (43)
Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
Percentage of Participants With an Objective Response Based on IRAC Review
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
- +38 more secondary outcomes
Study Arms (3)
Lenalidomide / Dexamethasone until disease progression
EXPERIMENTALLenalidomide plus low-dose dexamethasone given until disease progression
Lenalidomide / Dexamethasone for 18 cycles
EXPERIMENTALLenalidomide plus low-dose dexamethasone given for 18 four-week cycles
Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles
ACTIVE COMPARATORCombination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles
Interventions
Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression
lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles
Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles
Eligibility Criteria
You may qualify if:
- Must understand and voluntarily sign informed consent form
- Age ≥ 18 years at the time of signing consent
- Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
- MM diagnostic criteria (all 3 required):
- Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine
- Myeloma-related organ dysfunction (at least one of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5 mg/dl or upper limit of normal) \[R\] Renal insufficiency (serum creatinine \>2 mg/dl) \[A\] Anemia (hemoglobin \<10 g/dl or 2 g \< laboratory normal) \[B\] Lytic bone lesions or osteoporosis
- AND have measurable disease by protein electrophoresis analyses as defined by the following:
- IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
- IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours
- IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours
- IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours
- Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
- AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because:
- The patient declines to undergo stem cell transplantation or
- +14 more criteria
You may not qualify if:
- Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \[i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]).
- Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
- Pregnant or lactating females.
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) \< 1,000/µL (1.0 x 109/L)
- Untransfused platelet count \< 50,000 cells/µL (50 x 10\^9/L)
- Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN)
- Renal failure requiring hemodialysis or peritoneal dialysis.
- Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- Patients who are unable or unwilling to undergo antithrombotic therapy.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (288)
University of AL Birmingham
Birmingham, Alabama, 35294, United States
Cedar Sinai Medical Center Dept of Medicine
Los Angeles, California, 90048, United States
University of California, San Francisco- California
San Francisco, California, 94143, United States
Stanford University Stanford
Stanford, California, 94305, United States
Gainesville Heme Oncology Associates
Gainesville, Florida, 32607, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Integrated Community Oncology Network
Orange Park, Florida, 32073, United States
Gulf Coast Oncology
St. Petersburg, Florida, 33705, United States
Palm Beach Cancer Institute, LLC
West Palm Beach, Florida, 33401, United States
Southern Illinois Hematology Oncology
Centralia, Illinois, 62801, United States
Orchard Healthcare Research, Inc.
Chicago, Illinois, 60611, United States
John H Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Ingalls Cancer Institute
Harvey, Illinois, 60426-3558, United States
Cancer Center of Kansas
Wichita, Kansas, 67124, United States
Maine Center for Cancer Medicine Blood Disorders
Scarborough, Maine, 04074, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Billings Clinic
Billings, Montana, 59107, United States
Arena Oncology Associates, PC
Lake Success, New York, 11042, United States
Dakota Cancer Institute
Fargo, North Dakota, 58103, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Kaiser Permanente Northwest Oncology Hematology
Portland, Oregon, 97227, United States
St. Luke's Hospital and Health Network
Allentown, Pennsylvania, 18104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Cancer Center
Collierville, Tennessee, 38017, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0561, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
East Melbourne, Victoria, 3002, Australia
Western Hospital
Footscray, Victoria, 3011, Australia
Frankston Hospital
Frankston, Victoria, 3199, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Geelong Hospital
Geelong, 3220, Australia
Gosford Hospital
Gosford, 2250, Australia
Royal Brisbane and Women's Hospital
Herston, 4029, Australia
Cabrini Hospital
Malvern, 3144, Australia
The Royal Melbourne Hospital
Parkville, 3050, Australia
Royal Perth Hospital
Perth, 6000, Australia
Gold Coast Hospital
Southport, 4215, Australia
Royal North Shore Hospital
St Leonards, 2065, Australia
Westmead Hospital
Wentworthville, 2145, Australia
Border Medical Oncology
Wodonga, 3690, Australia
Wollongong Hospital
Wollongong, 2500, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Hospital Leoben
Leoben, 8700, Austria
Hospital of Barmherzige Schwestern Linz
Linz, 4010, Austria
Hospital of Elisabethinen Linz
Linz, 4010, Austria
General Hospital Linz
Linz, 4021, Austria
MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III
Salzburg, 5020, Austria
Hospital St. Polten
Sankt Pölten, 3100, Austria
Hospital of the Barmherzigen Bruder Vienna
Vienna, 1020, Austria
MM-015.Wihelminenspital
Vienna, 1160, Austria
MM-015. Medizinische Universität Wien
Vienna, A-1090, Austria
Hospital Wels
Wels, 4600, Austria
Hospital Wiener Neustadt
Wiener Neustadt, Austria
ZNA Stuivenberg Centrumziekenhuis
Antwerp, 2069, Belgium
Les Cliniques du Sud Luxembourg
Arlon, 6700, Belgium
AZ St-Jan Brugge Oostende AV
Bruges, 8000, Belgium
Jules Bordet Institut
Brussels, 1000, Belgium
Hopital Erasme
Brussels, 1070, Belgium
AZ-VUB
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
Virga Jesse Ziekenhuis
Hasselt, 3500, Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, 3000, Belgium
H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
Roeselare, 8800, Belgium
Cliniques Universitaires UCL de Mont-Godine
Yvoir, 5530, Belgium
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency
Kelowna, British Columbia, V1Y 5L3, Canada
Royal Columbian Hospital
New Westminster, British Columbia, V3M 1X4, Canada
BC Cancer Agency - Fraser Valley Centre
Surrey, British Columbia, V3V 1Z2, Canada
Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver Island Cancer Center
Victoria, British Columbia, V8R 6V5, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 3L6, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H2Y9, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Health Science Centre
London, Ontario, N6A 4G5, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Hospital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Hopital de la Cite-de-la-Sante
Laval, Quebec, H7M 3L9, Canada
Hotel-Dieu de Levis
Lévis, Quebec, G5V 3Z1, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, G4H 1C5, Canada
Hospital Maisonneuve - Rosemont
Montreal, Quebec, H1T 2M4, Canada
CHUM- Hopital Notre-Dame
Montreal, Quebec, H2L4M1, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Sir Mortimer B. Davis - Jewish Genl
Montreal, Quebec, H3T 1E2, Canada
CHUQ - Hotel-Dieu de QuebecHematology - Oncology
Québec, G1R 2J6, Canada
Chaoyang Hospital
Beijing, 100020, China
Peking University People's Hospital
Beijing, 100044, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Ruijin Hospital Shanghai Jiaotong University
Shanghai, 200025, China
Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Tianjin, 300041, China
Clinique Claude BernardOncologie
Albi, 81000, France
CHU Sud
Amiens, 80054, France
CHRU Hopital du bocage
Angers, 49033, France
CH Argenteuil Victor Dupouy
Argenteuil, 95100, France
Centre Hospitalier de la cote basque
Bayonne, 64109, France
Centre Hospitalier
Blois, 41016, France
Hopital Avicenne
Bobigny, 93009, France
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Hopital de Fleyriat
Bourg-en-Bresse, 01012, France
Hopital Augustin Morvan
Brest, 29609, France
CHU
Caen, 14033, France
Centre Francois Baclesse
Caen, 14076, France
CH
Cannes, 06401, France
CH Rene Dubois
Cergy-Pontoise, 95303, France
Centre Hospitalier William Morey
Chalon/Saone Cedex, 71321, France
Hopital Antoine Beclere
Clamart, 92141, France
Hopital dinstruction des armees Percy
Clamart, 92141, France
Chu Estaing
Clermont-Ferrand, 63000, France
CH Louis Pasteur
Colmar, 68024, France
Hopital Henri Mondor
Créteil, 94010, France
CHRU Hopital du bocage
Dijon, 21034, France
Centre Hospitalier General
Dunkirk, 59385, France
Institut Prive de Cancerologie
Grenoble, 38034, France
CHRU
Grenoble, 38043, France
Centre Hospitalier Departemental
La Roche-sur-Yon, 85925, France
CH
Le Chesnay, 78157, France
Hopital J MonodRhumato Nord
Le Havre, 76000, France
Kremlin Bicetre
Le Kremlin-Bicêtre, 942975, France
Centre Jean Bernard
Le Mans, 72000, France
Centre Hospitalier
Le Mans, 72037, France
GH de Institut Catholique St Vincent
Lille, 59000, France
CHRU-Hopital Claude Huriez
Lille, 59037, France
CH - Hôpital Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon, 69008, France
CHU Hopital Edouard Herriot
Lyon, 69437, France
Centre Hospitalier de Valence
Lyon, 69495, France
Institut Paoli-Calmettes
Marseille, 13009, France
Hopital de Mercy
Metz, 57085, France
Clinique Pont de chaume Oncologie et Radiotherapie
Montauban, 82017, France
CHU Montpellier - Hôpital Lapeyronie
Montpellier, 34295, France
Hopital Emile Muller
Mulhouse, 68000, France
CHRU - Hotel Dieu
Nantes, 44035, France
Centre Antoine Lacassagne Oncologie medicale et Hematologie
Nice, 06050, France
Hopital de lArchet 1
Nice, 06202, France
CH La Source
Orléans, 45000, France
Hopital Saint Louis
Paris, 75010, France
Hopital Necker
Paris, 75015, France
CHU Hôpital St-Antoine
Paris, 75571, France
Hopital Cochin
Paris, 75679, France
CHRU - Hopital du Haut Leveque
Pessac, 33604, France
CU CHU Clemenceau
Poitiers, 86021, France
Hopital R. Debre
Reims, 51032, France
CHU Reims - Hôpital Maison Blanche
Reims, 51100, France
CHRU Hôpital de Pontchaillou
Rennes, 35033, France
CHRU Hopital sud Medecine Interne
Rennes, 35056, France
CHG Rodez
Rodez, 12027, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Hospitalier Yves Le Foll
Saint-Brieuc, 22027, France
Centre Rene Huguenin
Saint-Cloud, 92210, France
Institut de Cancerologie de Loire
Saint-Priest-en-Jarez, 42270, France
CHRU Hôpital de Hautepierre
Strasbourg, 67098, France
CHRU Hopital Purpan
Toulouse, TSA 40031-31059, France
CHRU Hopital Bretonneau
Tours, 37044, France
CHRU Hopital Trousseau
Tours, 37044, France
CHRU Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
CH P. Chubert
Vannes, 56017, France
Institut Gustave Roussy
Villejuif, 94805, France
Medizinische Kinik und Poliklinik I
Dresden, D-01307, Germany
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Düsseldorf, 40225, Germany
Universitatsklinikum Essen-
Essen, 45122, Germany
Staedtische Kliniken Frankfurt am Main Hochst
Frankfurt am Main, 65929, Germany
Universitatsklinikum Giessen
Giessen, 35385, Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, 17487, Germany
Askepios Klinik St. Georg
Hamburg, 20099, Germany
Universitatsklinikum Jena
Jena, 07740, Germany
Medizinische Klinik und Poliklinik II
Leipzig, 04103, Germany
Universitatsklinikum schleswig-Holstein
Lübeck, 23538, Germany
Klinikum der Johann-Wolfgang-Goethe-Universtat
München, 81377, Germany
Medizinische Klinik III Klinikum der Universität München-Großhadern
München, 81377, Germany
Poliklinik A
Münster, 48129, Germany
Medizinische Fakultat der Universitat Rostock
Rostock, 18057, Germany
Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH
Stuttgart, D -70376, Germany
Medizinische Klinik - Abteilung II
Tübingen, 72076, Germany
Klinik fur Innere Medizin III
Ulm, 89081, Germany
Alexandra Hospital, University of Athens
Athens, 11528, Greece
Attiko Hospital of Athens
Athens, 124, Greece
Evangelismos Hospital of Athens
Athens, Greece
University of Athens
Athens, Greece
Metaxa Hospital Peiraias
Piraeus, 18537, Greece
Theagenio Anticancer Hospital of Thessaloniki
Thessaloniki, 540 07, Greece
Adelaide and Meath Hospital
Dublin, 24, Ireland
Mater Misercordiae Hospital
Dublin, 7, Ireland
University Hospital Galway
Galway, ST46QG, Ireland
Policlinico S. Orsola
Bologna, 40138, Italy
Oncologia Medica, Università della Magna Grecia
Catanzaro, 88100, Italy
Clinica Ematologica, A.O.U. San Martino di Genova
Genova, 16132, Italy
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
Lecce, 73100, Italy
Unità Operativa di Oncoematologia, Ospedale di Matera
Matera, 75100, Italy
U.O. di Ematologia e Trapianto di Midollo Osseo
Milan, 20132, Italy
Istituto Europeo di Oncologia - IEO
Milan, 20141, Italy
Presidio Ospedaliero A. Perrino
Milan, 20141, Italy
Policlinico di Modena
Modena, 41100, Italy
Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, 80131, Italy
Casa di Cura La Maddalena, Divisione di Ematologia
Palermo, 90146, Italy
Policlinico San Matteo Universita Di Pavia
Pavia, 27100, Italy
Ospedale Civile
Piacenza, 29100, Italy
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
Pisa, 56126, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
Roma, 00144, Italy
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
Rome, 00161, Italy
Ospedale Molinette
Torino, 10126, Italy
Auckland City Hospital
Auckland, 1023, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Wellington Hospital
Newtown, 6021, New Zealand
Hospital de Sao Marcos
Braga, Portugal
Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Instituto Portugues de Oncologia de Lisboa
Lisbon, 1099-023, Portugal
Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Instituto Português de Oncologia Porto
Porto, 4200-072, Portugal
Hospital de Santo Antonio- Porto
Porto, Portugal
Hallym University Sacred Heart Hospital
Anyang, 431-070, South Korea
Inje University Busan Paik Hospital
Busan, 614-735, South Korea
Daegu Catholic University Medical Center 3056-6
Daegu, 705-718, South Korea
Chungnam National University Hospital
Daejeon, 301-721, South Korea
National Cancer Center
Gyeonggi-do, 410-769, South Korea
Hwasun Chonnam National University Hospital
Hwasun-goon, 519-803, South Korea
Gachon University Gil Hospital
Incheon, 405-760, South Korea
Chonbuk National University Hospital 42
Jeonju, 561-712, South Korea
Seoul National University Bundang Hospital
Seongnam, 463-707, South Korea
Severance Hospital
Seongsanno, 120-752, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul, 137-701, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 158-710, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona), 8916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Instituto Catalan de Oncologia-Hospital Duran
Barcelona, 08907, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital de Donosti
Donostia / San Sebastian, 20014, Spain
Hospital Univ. Josep Trueta
Girona, 17007, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clinico Virgen de la Victoria
Málaga, 29010, Spain
Hospital General Universitario Morales Messeguer
Murcia, 30008, Spain
Hospital Son Llatzer
Palma de Mallorca, 7198, Spain
Clinica Universitaria de Navarra,
Pamplona, 31008, Spain
Hospital Sant Pau
Reus, 43201, Spain
Hospital Universtario Marques de Valdecilla
Santander, 39008, Spain
Hospital Clinico Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hosptial La Fe
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Linkoping University Hospital
Linköping, SE 581 85, Sweden
Karolinska University HospitalSolna
Stockholm, SE 17176, Sweden
St. Görans Hospital
Stockholm, SE- 11281, Sweden
Karolinska University Hospital Huddinge
Stockholm, SE-14186, Sweden
Abteilung Onkologie Haematologie des Kantonsspitals Aarau
Aarau, 5001, Switzerland
UniversitatsSpital Basel
Basel, 4031, Switzerland
Inselsspital Bern
Bern, 3010, Switzerland
Kantonsspital Graubunden
Chur, 7000, Switzerland
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, 1011, Switzerland
Kantonsspital Munsterlingen
Münsterlingen, 8596, Switzerland
Kantonsspital Winterthur
Winterthur, 8400, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
Veteran General Hospital - Taipei
Taipei, 11217, Taiwan
National Taiwan University Hospital
Tapei, 10002, Taiwan
Gwynedd Hospital
Bangor, LL57 2PW, United Kingdom
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Belfast City Hospital Haematology Department
Belfast Northern Ireland, BT9 7AB, United Kingdom
Birminghman QE
Birmingham West Midlands, B15 2TH, United Kingdom
Royal Bournemouth Hosp
Bournemouth Dorset, BH7 7DW, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 2QQ, United Kingdom
University Hospital of Wales - Cardiff
Cardiff, CF14 4XW, United Kingdom
The Beatson West of Scotland Centre
Glasgow, G12 0YN, United Kingdom
Dept of Haematology St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
Guy's and St Thomas' Hospital - London
London, SE1 9RT, United Kingdom
Royal Free Hospital
London, W12 0HS, United Kingdom
Churchhill Hospital
Oxford, OX3 7LI, United Kingdom
Derriford Hospital
Plymouth Crownhill Devon, PL6 8DH, United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield, S10 2JF, United Kingdom
Pinderfields General Hospital
West Yorkshire, WF1 4DG, United Kingdom
New Cross Hospital- Wolverhampton
Wolverhampton, WV10 OPQ, United Kingdom
Related Publications (13)
Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.
PMID: 26659916BACKGROUNDHulin C, Belch A, Shustik C, Petrucci MT, Duhrsen U, Lu J, Song K, Rodon P, Pegourie B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.
PMID: 27325857BACKGROUNDDelforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.
PMID: 25769541BACKGROUNDBenboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
PMID: 25184863BACKGROUNDVogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.
PMID: 28641472BACKGROUNDDumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.
PMID: 29784907BACKGROUNDAilawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.
PMID: 29980678BACKGROUNDJain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.
PMID: 30244101BACKGROUNDFacon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.
PMID: 29150421BACKGROUNDAilawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.
PMID: 30773308BACKGROUNDPegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.
PMID: 30859608BACKGROUNDBahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.
PMID: 28373701RESULTLu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.
PMID: 28106903RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne McClain, Senior Manager, Clinical Trial Disclosure
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Christian Jacques, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 4, 2008
Study Start
August 21, 2008
Primary Completion
July 14, 2016
Study Completion
July 14, 2016
Last Updated
November 20, 2019
Results First Posted
August 11, 2017
Record last verified: 2019-11