A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q
NCT ID: NCT01029262
Last Updated: 2019-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
239 participants
INTERVENTIONAL
2010-01-26
2018-05-09
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
QUADRUPLE
Study Groups
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Arm #1 - Lenalidomide plus placebo
Lenalidomide 10 mg by mouth (PO) daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and \< 60 mL/min.
Lenalidomide
One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
Arm #2 - placebo
Three placebo capsules once daily for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
Placebo
3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
Interventions
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Lenalidomide
One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
Placebo
3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q\[31\]
* Anemia that requires red blood cell transfusions
* Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level \> 500 mU/mL
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
* Must agree to follow pregnancy precautions as required by the protocol.
* Must agree to receive counseling related to teratogenic and other risks of lenalidomide
* Must agree not to donate blood or semen
* Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study
Exclusion Criteria
* Allergic reaction to thalidomide
* Renal insufficiency creatinine clearance (CrC1)\<40 mL/min by Cockcroft-Gault method)
* Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed)
* Absolute neutrophil count (ANC) \< 500/uL
* Platelets \< 50,000/uL
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3X upper limit of normal
* Uncontrolled hyperthyroidism or hypothyroidism
* Significant neuropathy
* Prior stem cell transplantation
* Anemia due to reasons other than MDS
* History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years
* Significant active cardiac disease within the past 6 months
* Known Human Immunodeficiency Virus (HIV) infection; known Hepatitis C infection or active Hepatitis B infection
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Hoenekopp, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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University of California at Los Angeles
Los Angeles, California, United States
Southern Illinois Hematology Oncology
Centralia, Illinois, United States
Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Wollongong Hospital
Wollongong, New South Wales, Australia
Royal Adelaide Hospital Institute of Medical and Veterinary Science
Adelaide, South Australia, Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Medizinische Universitat Innsbruck
Innsbruck, , Austria
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz, , Austria
Universitatsklinik fur Innere Medizin Salzburg
Salzburg, , Austria
Wiener Gebietskrankenkasse-Hanusch-Krankenhaus
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Weis, , Austria
AZ St-Jan Brugge Oostende AV
Bruges, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Grand Hopital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Centre Hospitalier Universitaire de Liege
Liège, , Belgium
Center Hospitalier Universitaire Ambroise Pare
Mons, , Belgium
Cliniques Universitaires UCL de Mont-Godine
Namur, , Belgium
Tom Baker Cancer Center
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Cancer Care Manitoba
Winnepeg, Manitoba, Canada
Sunnybrook Regional Cancer Center
Toronto, Ontario, Canada
Princess Margaret Hospital and University of Toronto
Toronto, Ontario, Canada
Maisonneuve Rosemont
Montreal, Quebec, Canada
McGill University, Dept. Oncology Clinical Research Program
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Ustav hematologie a krevni transfuze
Prague, , Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, , Czechia
CHU d'Angers
Angers, , France
Hopital Avicenne
Bobigny, , France
Hopital A. Michallon
La Tronche, , France
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille, , France
Institut Paoli-Calmettes
Marseille, , France
Groupe hospitalier Cochin Saint-Vincent de Paul
Paris, , France
Universitat zu Koln
Cologne, , Germany
BAG Freiberg-Richter, Jacobash, Illmer, Wolf
Dresden, , Germany
Sankt Johannes Hospital Duisburg
Duisberg, , Germany
Universitätsklinikum Düsseldorf
Düesseldorf, , Germany
Marien Hospital
Düsseldorf, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum Mannheim der Universitat Heidelberg
Heidelberg, , Germany
Universitatsklinikum Mannheim
Mannheim, , Germany
TU München - Klinikum rechts der Isar
München, , Germany
Rabin Medical Center
Petah Tikva, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Az. Osp. SS.Antonio e Biagio - SC Ematologia
Alessandria, , Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna, , Italy
P.O. Ospedale Roberto Binaghi (UNI CA/ASL 8)
Cagliari, , Italy
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Cardarelli
Naples, , Italy
AOU San Luigi Gonzaga
Orbassano, , Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, , Italy
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
Roma, , Italy
Policlinico Agostino Gemelli - Istituto di Ematologia
Roma, , Italy
Policlinico Univeristario di Udine
Udine, , Italy
Hiroshima University Hospital
Hiroshima, , Japan
Tokai University School of Medicine
Isehara City, Kanagawa, , Japan
Kameda General Hospital
Kamogawa, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Nagasaki Unversity Hospital
Nagasaki, , Japan
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
Osaka Red Cross Hospital
Osaka, , Japan
Tohoku University Hospital
Sendai, , Japan
Japanese Red Cross Medical Center
Shibuya City, , Japan
Jichi Medical University Hospital
Shimotsuke, , Japan
Kanto Medical Center NTT EC
Shinagawa City, , Japan
Katedra i Klinika Hematologii i Transplantacji Szpiku - SLASKIEGO UNIWERSYTETU MEDYCZNEGO
Gdansk, , Poland
Uniwersytet Medyczny w Lodzi
Lodz, , Poland
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Warsaw, , Poland
Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa
Lisbon, , Portugal
Hospital Geral de Santo Antonio
Porto, , Portugal
Hospital Clinic Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Gazi Universitesi Tip Fakltesi
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, , Turkey (Türkiye)
Istanbul Universitesi Istanbul
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Faiultesi
Izimir, , Turkey (Türkiye)
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Saint James University Hospital
Leeds, , United Kingdom
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Santini V, Almeida A, Giagounidis A, Gropper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Canizo C, Gattermann N, Ozawa K, Risueno A, MacBeth KJ, Zhong J, Seguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. doi: 10.1200/JCO.2015.66.0118. Epub 2016 Jun 27.
Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P. Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels. Leuk Lymphoma. 2020 Jun;61(6):1475-1483. doi: 10.1080/10428194.2020.1719088. Epub 2020 Feb 17.
Almeida A, Fenaux P, Garcia-Manero G, Goldberg SL, Gropper S, Jonasova A, Vey N, Castaneda C, Zhong J, Beach CL, Santini V. Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial. Leuk Lymphoma. 2018 Sep;59(9):2135-2143. doi: 10.1080/10428194.2017.1421758. Epub 2018 Jan 11.
Other Identifiers
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CC-5013-MDS-005
Identifier Type: -
Identifier Source: org_study_id
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