Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
NCT ID: NCT00689936
Last Updated: 2019-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1623 participants
INTERVENTIONAL
2008-08-21
2016-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lenalidomide / Dexamethasone until disease progression
Lenalidomide plus low-dose dexamethasone given until disease progression
Lenalidomide and low-dose dexamethasone
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 / Dexamethasone for 18 cycles
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
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, Prednisone, and Thalidomide (MPT) for 12 cycles
Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles
Melphalan, Prednisone and Thalidomide
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
Interventions
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Lenalidomide and low-dose dexamethasone
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 plus low-dose dexamethasone given for 18 four-week cycles
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, Prednisone and Thalidomide
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years at the time of signing consent
3. 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
* Stem cell transplantation is not available to the patient due to cost or other reasons
4. ECOG performance status of 0, 1, or 2
5. Able to adhere to the study visit schedule and other protocol requirements
6. Females of child-bearing potential (FCBP)\^2:
1. Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
2. Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
7. Male Patients:
1. Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
2. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
3. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
8. All patients must:
1. Have an understanding that the study drug could have a potential teratogenic risk.
2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
3. Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure.
Exclusion Criteria
2. 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.
3. Pregnant or lactating females.
4. 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)
5. Renal failure requiring hemodialysis or peritoneal dialysis.
6. 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)
7. Patients who are unable or unwilling to undergo antithrombotic therapy.
8. Peripheral neuropathy of \> grade 2 severity.
9. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
* 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
* 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Christian Jacques, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Attiko Hospital of Athens
Athens, , Greece
Evangelismos Hospital of Athens
Athens, , Greece
University of Athens
Athens, , Greece
Metaxa Hospital Peiraias
Piraeus, , Greece
Theagenio Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Adelaide and Meath Hospital
Dublin, , Ireland
Mater Misercordiae Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Policlinico S. Orsola
Bologna, , Italy
Oncologia Medica, Università della Magna Grecia
Catanzaro, , Italy
Clinica Ematologica, A.O.U. San Martino di Genova
Genova, , Italy
University of AL Birmingham
Birmingham, Alabama, United States
Cedar Sinai Medical Center Dept of Medicine
Los Angeles, California, United States
University of California, San Francisco- California
San Francisco, California, United States
Stanford University Stanford
Stanford, California, United States
Gainesville Heme Oncology Associates
Gainesville, Florida, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Integrated Community Oncology Network
Orange Park, Florida, United States
Gulf Coast Oncology
St. Petersburg, Florida, United States
Palm Beach Cancer Institute, LLC
West Palm Beach, Florida, United States
Southern Illinois Hematology Oncology
Centralia, Illinois, United States
Orchard Healthcare Research, Inc.
Chicago, Illinois, United States
John H Stroger Hospital of Cook County
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Ingalls Cancer Institute
Harvey, Illinois, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Maine Center for Cancer Medicine Blood Disorders
Scarborough, Maine, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Billings Clinic
Billings, Montana, United States
Arena Oncology Associates, PC
Lake Success, New York, United States
Dakota Cancer Institute
Fargo, North Dakota, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Kaiser Permanente Northwest Oncology Hematology
Portland, Oregon, United States
St. Luke's Hospital and Health Network
Allentown, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Cancer Center
Collierville, Tennessee, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
East Melbourne, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Flinders Medical Centre
Bedford Park, , Australia
Geelong Hospital
Geelong, , Australia
Gosford Hospital
Gosford, , Australia
Royal Brisbane and Women's Hospital
Herston, , Australia
Cabrini Hospital
Malvern, , Australia
The Royal Melbourne Hospital
Parkville, , Australia
Royal Perth Hospital
Perth, , Australia
Gold Coast Hospital
Southport, , Australia
Royal North Shore Hospital
St Leonards, , Australia
Westmead Hospital
Wentworthville, , Australia
Border Medical Oncology
Wodonga, , Australia
Wollongong Hospital
Wollongong, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Hospital Leoben
Leoben, , Austria
Hospital of Barmherzige Schwestern Linz
Linz, , Austria
Hospital of Elisabethinen Linz
Linz, , Austria
General Hospital Linz
Linz, , Austria
MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III
Salzburg, , Austria
Hospital St. Polten
Sankt Pölten, , Austria
Hospital of the Barmherzigen Bruder Vienna
Vienna, , Austria
MM-015.Wihelminenspital
Vienna, , Austria
MM-015. Medizinische Universität Wien
Vienna, , Austria
Hospital Wels
Wels, , Austria
Hospital Wiener Neustadt
Wiener Neustadt, , Austria
ZNA Stuivenberg Centrumziekenhuis
Antwerp, , Belgium
Les Cliniques du Sud Luxembourg
Arlon, , Belgium
AZ St-Jan Brugge Oostende AV
Bruges, , Belgium
Jules Bordet Institut
Brussels, , Belgium
Hopital Erasme
Brussels, , Belgium
AZ-VUB
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
Virga Jesse Ziekenhuis
Hasselt, , Belgium
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, , Belgium
H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
Roeselare, , Belgium
Cliniques Universitaires UCL de Mont-Godine
Yvoir, , Belgium
University of Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Kelowna, British Columbia, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
BC Cancer Agency - Fraser Valley Centre
Surrey, British Columbia, Canada
Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
Vancouver, British Columbia, Canada
Vancouver Island Cancer Center
Victoria, British Columbia, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Science Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hospital Charles LeMoyne
Greenfield Park, Quebec, Canada
Hopital de la Cite-de-la-Sante
Laval, Quebec, Canada
Hotel-Dieu de Levis
Lévis, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Hospital Maisonneuve - Rosemont
Montreal, Quebec, Canada
CHUM- Hopital Notre-Dame
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Sir Mortimer B. Davis - Jewish Genl
Montreal, Quebec, Canada
CHUQ - Hotel-Dieu de QuebecHematology - Oncology
Québec, , Canada
Chaoyang Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
West China Hospital of Sichuan University
Chengdu, , China
Ruijin Hospital Shanghai Jiaotong University
Shanghai, , China
Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Tianjin, , China
Clinique Claude BernardOncologie
Albi, , France
CHU Sud
Amiens, , France
CHRU Hopital du bocage
Angers, , France
CH Argenteuil Victor Dupouy
Argenteuil, , France
Centre Hospitalier de la cote basque
Bayonne, , France
Centre Hospitalier
Blois, , France
Hopital Avicenne
Bobigny, , France
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hopital de Fleyriat
Bourg-en-Bresse, , France
Hopital Augustin Morvan
Brest, , France
CHU
Caen, , France
Centre Francois Baclesse
Caen, , France
CH
Cannes, , France
CH Rene Dubois
Cergy-Pontoise, , France
Centre Hospitalier William Morey
Chalon/Saone Cedex, , France
Hopital Antoine Beclere
Clamart, , France
Hopital dinstruction des armees Percy
Clamart, , France
Chu Estaing
Clermont-Ferrand, , France
CH Louis Pasteur
Colmar, , France
Hopital Henri Mondor
Créteil, , France
CHRU Hopital du bocage
Dijon, , France
Centre Hospitalier General
Dunkirk, , France
Institut Prive de Cancerologie
Grenoble, , France
CHRU
Grenoble, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
CH
Le Chesnay, , France
Hopital J MonodRhumato Nord
Le Havre, , France
Kremlin Bicetre
Le Kremlin-Bicêtre, , France
Centre Jean Bernard
Le Mans, , France
Centre Hospitalier
Le Mans, , France
GH de Institut Catholique St Vincent
Lille, , France
CHRU-Hopital Claude Huriez
Lille, , France
CH - Hôpital Dupuytren
Limoges, , France
Centre Leon Berard
Lyon, , France
CHU Hopital Edouard Herriot
Lyon, , France
Centre Hospitalier de Valence
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Hopital de Mercy
Metz, , France
Clinique Pont de chaume Oncologie et Radiotherapie
Montauban, , France
CHU Montpellier - Hôpital Lapeyronie
Montpellier, , France
Hopital Emile Muller
Mulhouse, , France
CHRU - Hotel Dieu
Nantes, , France
Centre Antoine Lacassagne Oncologie medicale et Hematologie
Nice, , France
Hopital de lArchet 1
Nice, , France
CH La Source
Orléans, , France
Hopital Saint Louis
Paris, , France
Hopital Necker
Paris, , France
CHU Hôpital St-Antoine
Paris, , France
Hopital Cochin
Paris, , France
CHRU - Hopital du Haut Leveque
Pessac, , France
CU CHU Clemenceau
Poitiers, , France
Hopital R. Debre
Reims, , France
CHU Reims - Hôpital Maison Blanche
Reims, , France
CHRU Hôpital de Pontchaillou
Rennes, , France
CHRU Hopital sud Medecine Interne
Rennes, , France
CHG Rodez
Rodez, , France
Centre Henri Becquerel
Rouen, , France
Centre Hospitalier Yves Le Foll
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Institut de Cancerologie de Loire
Saint-Priest-en-Jarez, , France
CHRU Hôpital de Hautepierre
Strasbourg, , France
CHRU Hopital Purpan
Toulouse, , France
CHRU Hopital Bretonneau
Tours, , France
CHRU Hopital Trousseau
Tours, , France
CHRU Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
CH P. Chubert
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Medizinische Kinik und Poliklinik I
Dresden, , Germany
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Düsseldorf, , Germany
Universitatsklinikum Essen-
Essen, , Germany
Staedtische Kliniken Frankfurt am Main Hochst
Frankfurt am Main, , Germany
Universitatsklinikum Giessen
Giessen, , Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, , Germany
Askepios Klinik St. Georg
Hamburg, , Germany
Universitatsklinikum Jena
Jena, , Germany
Medizinische Klinik und Poliklinik II
Leipzig, , Germany
Universitatsklinikum schleswig-Holstein
Lübeck, , Germany
Klinikum der Johann-Wolfgang-Goethe-Universtat
München, , Germany
Medizinische Klinik III Klinikum der Universität München-Großhadern
München, , Germany
Poliklinik A
Münster, , Germany
Medizinische Fakultat der Universitat Rostock
Rostock, , Germany
Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH
Stuttgart, , Germany
Medizinische Klinik - Abteilung II
Tübingen, , Germany
Klinik fur Innere Medizin III
Ulm, , Germany
Alexandra Hospital, University of Athens
Athens, , Greece
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
Lecce, , Italy
Unità Operativa di Oncoematologia, Ospedale di Matera
Matera, , Italy
U.O. di Ematologia e Trapianto di Midollo Osseo
Milan, , Italy
Istituto Europeo di Oncologia - IEO
Milan, , Italy
Presidio Ospedaliero A. Perrino
Milan, , Italy
Policlinico di Modena
Modena, , Italy
Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Casa di Cura La Maddalena, Divisione di Ematologia
Palermo, , Italy
Policlinico San Matteo Universita Di Pavia
Pavia, , Italy
Ospedale Civile
Piacenza, , Italy
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
Pisa, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
Roma, , Italy
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
Rome, , Italy
Ospedale Molinette
Torino, , Italy
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Wellington Hospital
Newtown, , New Zealand
Hospital de Sao Marcos
Braga, , Portugal
Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Instituto Português de Oncologia Porto
Porto, , Portugal
Hospital de Santo Antonio- Porto
Porto, , Portugal
Hallym University Sacred Heart Hospital
Anyang, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Daegu Catholic University Medical Center 3056-6
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Hwasun Chonnam National University Hospital
Hwasun-goon, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Chonbuk National University Hospital 42
Jeonju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Severance Hospital
Seongsanno, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona), , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Instituto Catalan de Oncologia-Hospital Duran
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital de Donosti
Donostia / San Sebastian, , Spain
Hospital Univ. Josep Trueta
Girona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Virgen de la Victoria
Málaga, , Spain
Hospital General Universitario Morales Messeguer
Murcia, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
Clinica Universitaria de Navarra,
Pamplona, , Spain
Hospital Sant Pau
Reus, , Spain
Hospital Universtario Marques de Valdecilla
Santander, , Spain
Hospital Clinico Santiago de Compostela
Santiago de Compostela, , Spain
Hosptial La Fe
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Linkoping University Hospital
Linköping, , Sweden
Karolinska University HospitalSolna
Stockholm, , Sweden
St. Görans Hospital
Stockholm, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
Abteilung Onkologie Haematologie des Kantonsspitals Aarau
Aarau, , Switzerland
UniversitatsSpital Basel
Basel, , Switzerland
Inselsspital Bern
Bern, , Switzerland
Kantonsspital Graubunden
Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, , Switzerland
Kantonsspital Munsterlingen
Münsterlingen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
Veteran General Hospital - Taipei
Taipei, , Taiwan
National Taiwan University Hospital
Tapei, , Taiwan
Gwynedd Hospital
Bangor, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Belfast City Hospital Haematology Department
Belfast Northern Ireland, , United Kingdom
Birminghman QE
Birmingham West Midlands, , United Kingdom
Royal Bournemouth Hosp
Bournemouth Dorset, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital of Wales - Cardiff
Cardiff, , United Kingdom
The Beatson West of Scotland Centre
Glasgow, , United Kingdom
Dept of Haematology St Bartholomews Hospital
London, , United Kingdom
Guy's and St Thomas' Hospital - London
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Churchhill Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth Crownhill Devon, , United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield, , United Kingdom
Pinderfields General Hospital
West Yorkshire, , United Kingdom
New Cross Hospital- Wolverhampton
Wolverhampton, , United Kingdom
Countries
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References
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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.
Hulin 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.
Delforge 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.
Benboubker 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.
Vogl 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.
Dumontet 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.
Ailawadhi 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.
Jain 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.
Facon 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.
Ailawadhi 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.
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Bahlis 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.
Lu 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.
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Other Identifiers
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2007-004823-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-5013-MM-020
Identifier Type: -
Identifier Source: org_study_id
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