A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Low Risk Myelodysplastic Syndrome (MDS) Without Del 5Q (MDS-005)
This study is currently recruiting participants.
Verified March 2013 by Celgene Corporation
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01029262
First received: December 8, 2009
Last updated: March 11, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions needed by anemic (RBC transfusion-dependent) subjects with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study will also investigate the safety of lenalidomide use in these subjects. Two-thirds of the subjects will receive lenalidomide and one-third of the subjects will receive placebo (does not contain lenalidomide).
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia |
Drug: Lenalidomide Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Placebo-Controlled Study to Compare the Efficacy and Safety of Lenalidomide vs. Placebo in Subjects With Transfusion Dependent Anemia Due to Low or Intermediate Risk MDS and Unresponsive to ESA Therapies |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Proportion of subjects that become transfusion independent. Proportion of subjects with an erythroid differentiation gene expression signature that become transfusion independent. [ Time Frame: Up to 4 years for each subject (likely to be 6 months to 2 years) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the safety of lenalidomide versus placebo. [ Time Frame: up to 6 years from study start through follow-up ] [ Designated as safety issue: Yes ]
- Evaluate the impact of lenalidomide therapy on health-related quality of life (HRQOL) and use of healthcare resources. [ Time Frame: up to 6 years from study start through follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 228 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm #1 - Lenalidomide
10 mg lenalidomide once daily (administered as one 10-mg lenalidomide capsule + 2 placebo capsules)
|
Drug: 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) Other Name: Revlimid
|
|
Placebo Comparator: Arm #2 - placebo
Three placebo capsules once daily. Subjects will be randomized using a 2:1 ratio in a double-blind manner to receive oral lenalidomide 10 mg once daily or placebo once daily. Subjects will receive oral lenalidomide 10 mg once daily (one 10 mg lenalidomide capsules + 2 placebo capsule) or matching placebo once daily (3 placebo capsules).
|
Other: 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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or older
- Diagnosis of low or intermediate-1 risk 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
- ECOG Performance Status ≤ 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:
- Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or DNA modulation agents
- Allergic reaction to thalidomide
- Renal insufficiency (CrC1<40 mL/min by Cockroft-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 T1a or T1b prostate cancer is allowed)
- Absolute neutrophil count < 500/uL
- Platelets < 50,000/uL
- AST or 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 HIV infection; known Hepatitis C infection or active Hepatitis B infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029262
Hide Study Locations
Contacts
| Contact: Anne McClain, RN, BSN | 913-266-0336 | amcclain@celgene.com |
| Contact: Joanna Sobierska | 011-41-327298414 | jsobierska@celgene.com |
Hide Study LocationsLocations
| United States, California | |
| (853) University of California Los Angeles Medical Center | Withdrawn |
| Los Angeles, California, United States, 90095 | |
| United States, Illinois | |
| (858) Southern Illinois Hematology Oncology | Withdrawn |
| Centralia, Illinois, United States, 62801 | |
| United States, New Hampshire | |
| (851) Dartmouth Hitchcock Medical Center | Withdrawn |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| (857) Hackensack University Medical Center | Withdrawn |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| (852) Columbia University Medical Center | Withdrawn |
| New York, New York, United States, 10032 | |
| United States, Texas | |
| (855) University of Texas, MD Anderson Cancer Center | Withdrawn |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Medical College of Wisconsin, Froedtert Hospital | Withdrawn |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, New South Wales | |
| (005) Wollongong Hospital | Withdrawn |
| Wollongong, New South Wales, Australia, 2500 | |
| Australia, Queensland | |
| (004) Princess Alexandra Hospital | Recruiting |
| Woolloongabba, Queensland, Australia, 4102 | |
| Contact +61 7 3240 2086 | |
| Australia, South Australia | |
| (002) Royal Adelaide Hospital | Withdrawn |
| Adelaide, South Australia, Australia, 5000 | |
| Austria | |
| (151) Medizinische Universitat Innsbruck | Recruiting |
| Innsbruck, Tyrol, Austria, 6020 | |
| Contact +43 512 504 23255 | |
| (152) Wiener Gebietskrankenkasse-Hanusch-Krankenhaus | Recruiting |
| Wien, Vienna, Austria, 1140 | |
| Contact +43 191 021 85430 | |
| (153) Krankenhaus der Elisabethinen Linz, Interne Abteilung | Recruiting |
| Linz, Austria, 4020 | |
| (154) Universitätsklinik für Innere Medizin Salzburg | Recruiting |
| Salzburg, Austria, 5020 | |
| Contact +43 662 4482 2880 | |
| (155) Klinikum Wels-Grieskirchen GmbH | Recruiting |
| Wels, Austria, 4600 | |
| Contact +43 7242 415 3451 | |
| Belgium | |
| (202) Universitair Ziekenhuis Antwerpen | Withdrawn |
| Edegem, Antwerpen, Belgium, 2650 | |
| (204) Center Hospitalier Universitaire Ambroise Paré | Withdrawn |
| Mons, Henegouwen, Belgium, 7000 | |
| (207) Cliniques Universitaires UCL de Mont-Godinne | Recruiting |
| Yvoir, Namur, Belgium, 5530 | |
| Contact +32 81 42 47 64 | |
| (203) Algemeen Ziekenhuis Sint-Jan | Recruiting |
| Brugge, West-Vlaanderen, Belgium, 8000 | |
| Contact +32 504 53060 | |
| (206) Cliniques Universitaires Saint Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| (205) Grand Hôpital de Charleroi | Recruiting |
| Charleroi, Belgium, 6000 | |
| (201) Centre Hospitalier Universitaire Sart Tilman Liège | Withdrawn |
| Liege, Belgium, 4000 | |
| Canada, Alberta | |
| (804) University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, Manitoba | |
| (805) Cancer Care Manitoba | Withdrawn |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| (801) Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| (806) Sunnybrook Odette Cancer Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact 416 480 5847 | |
| Canada, Quebec | |
| (807) Maisonneuve-Rosemont Hospital | Withdrawn |
| Montreal, Quebec, Canada, H1T 2M4 | |
| (808) McGill University | Withdrawn |
| Montreal, Quebec, Canada, QC H2W 1S6 | |
| (802) Hôpital du Sacré-Coeur de Montréal | Withdrawn |
| Montréal, Quebec, Canada, H4J 1C5 | |
| Canada | |
| Tom Baker Cancer Center | Withdrawn |
| Calgary, Canada, T2N 4N2 | |
| Czech Republic | |
| (252) Fakultni nemocnice Olomouc, hemato-onkologicka klinika | Recruiting |
| Olomouc, Czech Republic, 77920 | |
| (251) Fakultni nemocnice Olomouc, hemato-onkologicka klinika | Withdrawn |
| Olomouc, Czech Republic, 779 20 | |
| (254) Ustav Hematologie a Krevni Transfuze | Recruiting |
| Praha, Czech Republic, 2 128 20 | |
| Contact +420 2 2496 2839 | |
| (253) Vseobecna Fakultni Nemocnice v Praze | Recruiting |
| Praha, Czech Republic, 2 1280 08 | |
| France | |
| (307) Center Hospitalier Universitaire d' Angers | Withdrawn |
| Angers Cedex 9, France, 49933 | |
| (304) Hôpital Avicenne - Service d'Hématologie Clinique | Recruiting |
| Bobigny, France, 93009 | |
| (303) Hopital A. Michallon | Recruiting |
| La Tronche, France, 38700 | |
| Contact +33 4 76 76 57 12 | |
| (305) Hôpital Claude Hurlezk service des maladies du sang | Recruiting |
| Lille Cedex, France, 59037 | |
| (306) Institut Paoli Calmettes Centre Regional de Lutte Contre le Cancer | Recruiting |
| Marseille, France, Cedex 09 13273 | |
| Contact +33 04 91 22 36 95 | |
| (302) Groupe hospitalier Cochin Saint-Vincent de Paul | Withdrawn |
| Paris Cedex 14, France, 75679 | |
| Germany | |
| (357) Universitat Heidelberg | Recruiting |
| Heidelberg, Baden-Wuerttemberg, Germany, 69120 | |
| (353) Universitatsklinikum Mannheim | Recruiting |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| Contact +49 621 383 6947 | |
| (355) Klinikum rechts der Isar, Technische Universitat Munchen | Recruiting |
| Munchen, Bayern, Germany, 81675 | |
| Contact +49 89 4140 5618 | |
| (354) Medizinische Hochschutle Hannover | Withdrawn |
| Hannover, Niedersachsen, Germany, 30625 | |
| (358) Universitat zu Koln | Withdrawn |
| Koln, Nordrhein-Wesfalen, Germany, 50924 | |
| (352) Sankt Johannes Hospital Duisburg | Recruiting |
| Duisburg, Nordrhein-Westfalen, Germany, 47166 | |
| Contact +49 203 546 2480 | |
| (356) Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie | Recruiting |
| Düsseldorf, Nordrhein-Westfalen, Germany, 40211 | |
| Contact +49 211 8117780 | |
| (359) Gemeinschaftspraxis fur Hamatologie un Onkologie | Recruiting |
| Dresden, Germany, 01307 | |
| Israel | |
| (404) Rabin Medical Center | Recruiting |
| Petach Tikva, Israel, 49100 | |
| (401) Tel Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel, 64239 | |
| (402) Chaim Sheba Medical Center | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| (455) IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture | Recruiting |
| Rionero in Vulture, Potenza, Italy, 85028 | |
| Contact +39 0972726729 | |
| (459) Azienda Sanitaria Ospedaliera "San Luigi Gonzaga" | Withdrawn |
| Orbassano, Turin, Italy, 10043 | |
| (456) Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Allessandria | Recruiting |
| Alessandria, Italy, 15100 | |
| Contact +39 0131 206262 | |
| (460) Instituto Di Ematologia ED Oncologia Medica "LA Seragnoli" Policlinico S. Orsola Malpighi | Recruiting |
| Bologna, Italy, 40138 | |
| (461) Ospedale R. Binaghi | Recruiting |
| Cagliari, Italy, 09100 | |
| Contact +39 076 092936 | |
| (457) Azienda Ospedaliero-Universitaria di Cagliari | Withdrawn |
| Cagliari, Italy, 09121 | |
| (462) Azienda Ospedalieo - Universitaria Careggi | Recruiting |
| Firenze, Italy, 50139 | |
| Contact +39 055 7947296 | |
| (458) AORN A. Cardarelli | Withdrawn |
| Naples, Italy, 80131 | |
| (463) Universita Cattolica Sacro Cuore | Recruiting |
| Roma, Italy, 00168 | |
| (453) Azienda Policlinico Umberto l di Roma | Recruiting |
| Roma, Italy, 00161 | |
| Contact +39 06 44241984 | |
| (452) Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Recruiting |
| Roma, Italy, 00133 | |
| Contact +39 06 20903219 | |
| (451) Azienda Ospedaliero Universitaria "S. Maria della Misericordia" di Udine | Recruiting |
| Udine, Italy, 33100 | |
| Japan | |
| (906) National Hospital Organization Nagoya Medical Center | Recruiting |
| Nagoya, Aichi, Japan, 460-0001 | |
| Contact +052 951 1111 | |
| (910) Kameda General Hospital | Recruiting |
| Kamogawa, Chiba, Japan, 296-8602 | |
| Contact +81 4 7092 2211 | |
| (911) Tohoku University Hospital | Recruiting |
| Sendai, Fukushima, Japan, 980-8574 | |
| Contact +81 2 2717 7000 | |
| (905) Kanazawa University Hospital | Withdrawn |
| Kanazawa, Iskikawa, Japan, 920-8641 | |
| (904) Tokai University School of Medicine | Recruiting |
| Isehara, Kanagawa, Japan, 259-1193 | |
| Contact +0463-93-1121 | |
| (901) Jichi Medical University Hospital | Recruiting |
| Shimotsuke, Tochigi, Japan, 329-0498 | |
| Contact +0285 58 7353 | |
| (902) Japanese Red Cross Medical Center | Recruiting |
| Shibuya, Tokyo, Japan, 150-8935 | |
| Contact +03 3400 1311 | |
| (903) Kanto Medical Center NTT EC | Recruiting |
| Shinagawa, Tokyo, Japan, 141-8625 | |
| (908) Hiroshima University Hospital | Recruiting |
| Hiroshima, Japan, 734-8551 | |
| (909) Nagasaki University Hospital | Withdrawn |
| Nagasaki, Japan, 852-8501 | |
| (907) Osaka Red Cross Hospital | Recruiting |
| Osaka, Japan, 543-6555 | |
| Contact +06 6774 5111 | |
| Poland | |
| (502) Lodzki Uniwersytet Medyczny, Klinika Hematologii | Withdrawn |
| Lodz, Lodzkie, Poland, 93-510 | |
| (504) Katedra I Klinika Hematologii z Osrodkiem Transplantacji Szpiku Kostnego AM; SPSK nr 1 | Recruiting |
| Gdansk, Pomorskie, Poland, 80-952 | |
| (503) Instytut Hematologii i Tansfuzjologii, Klinika Hematologii | Recruiting |
| Warsaw, Poland, 02-776 | |
| Portugal | |
| (553) Hospitais da Universidade de Coimbra | Recruiting |
| Coimbra, Portugal, 3000-076 | |
| (552) Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE | Recruiting |
| Lisboa, Portugal, 1090-023 | |
| Contact +35 191907747 | |
| (551) Hospital Geral de Santo Antonio | Withdrawn |
| Porto, Portugal, 4099-001 | |
| Spain | |
| (602) Hospital Son Llatzer | Recruiting |
| Palma de Mallorca, Baleares, Spain, 7198 | |
| Contact +34 871 202138 | |
| (607) Hospital Clinic i Provincial - Servicio de Hematologia y Hemoterapia | Recruiting |
| Barcelona, Spain, 8036 | |
| Contact +34 932275428 | |
| (606) Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Contact +34 91 2071247 | |
| (603) Hospital Clinico Universitario Virgen de la Victoria | Recruiting |
| Malaga, Spain, 29010 | |
| Contact +34 951 032 000 | |
| (605) Hospital Universitario de Salamanca, Hospital Clinico, Sevicio de Hematologia | Recruiting |
| Salamanca, Spain, 37007 | |
| Contact +34 923 291384 | |
| (608) Hospital Universitario Virgen del Rocio | Recruiting |
| Sevilla, Spain, 41013 | |
| Contact +34 955013161 | |
| (601) Hospital La Fe, Servicio de Hematologia | Recruiting |
| Valencia, Spain, 46009 | |
| Contact +4 96 3862709 | |
| Turkey | |
| (654) Gazi Universitesi Tip Fakultesi | Recruiting |
| Ankara, Turkey, 06500 | |
| (651) Akdeniz Universitesi Tip Fakultesi | Withdrawn |
| Antalya, Turkey, 07509 | |
| (652) Istanbul Universitesi Istanbul Tip Fakultesi | Recruiting |
| Istanbul, Turkey, 34390 | |
| (653) Dokuz Eylul Universitesi Tip Fakultesi | Recruiting |
| Izmir, Turkey, 35340 | |
| United Kingdom | |
| (707) Royal Bournemouth Hospital | Recruiting |
| Bournemouth, England, United Kingdom, BH7 7DW | |
| Contact +44 1202 704783 | |
| (704) Saint James' University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS1 3EX | |
| Contact +44 113 2068481 | |
| (702) King's College Hospital | Recruiting |
| London, England, United Kingdom, SE5 9RS | |
| Contact +44 2032993080 | |
| (708) Barts and the London NHS Trust | Withdrawn |
| London, England, United Kingdom, EC1A 7B3 | |
| (701) Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact +44 845 226 3000 | |
| (705) John Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 9DS | |
| Contact +44 1805 222489 | |
| (706) University Hospital of Wales | Recruiting |
| Cardiff, Wales, United Kingdom, CF1F 4XW | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Bouchra Benettaib, MD | Celgene Corporation |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT01029262 History of Changes |
| Other Study ID Numbers: | CC-5013-MDS-005 |
| Study First Received: | December 8, 2009 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Israel: Ministry of Health Japan: Pharmaceuticals and Medical Devices Agency Italy: The Italian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute Spain: Spanish Agency of Medicines Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Celgene Corporation:
|
Myelodysplastic Syndromes MDS transfusion dependent anemia Erythropoiesis stimulating agents non-del 5q |
Additional relevant MeSH terms:
|
Anemia Myelodysplastic Syndromes Preleukemia Hematologic Diseases Bone Marrow Diseases Precancerous Conditions Neoplasms Lenalidomide Thalidomide Hematinics Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013