Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
NCT ID: NCT01712789
Last Updated: 2022-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
682 participants
INTERVENTIONAL
2012-11-06
2019-12-11
Brief Summary
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The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.
In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.
The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pomalidomide plus Dexamethasone
Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
Pomalidomide
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
Dexamethasone
Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
Interventions
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Pomalidomide
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
Dexamethasone
Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
* Patients must have documented diagnosis of Multiple Myeloma and have measurable disease.
* Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy.
* Patients must have either refractory or relapsed and refractory disease.
* Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens.
* Patients must have received adequate alkylator therapy
Exclusion Criteria
* Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone.
* Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
* Patients who are planning for or who are eligible for stem cell transplant.
* Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment.
* Patients with a current disease that can interfere with protocol procedures or study treatment.
* Patients unable or unwilling to undergo antithrombotic prophylactic treatment.
* Pregnant or breastfeeding females.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Teresa Peluso, MBBS, DCPSA
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Medical University of Graz
Graz, , Austria
Medizinische Universitat Innsbruck
Innsbruck, , Austria
Wilhelminenspital Vienna
Vienna, , Austria
Medical University of Vienna
Vienna, , Austria
AZ St-Jan Brugge Oostende AV
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
VUB Vrije Universiteit Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege
Liège, , Belgium
CHU Mont -Godinne
Yvoir, , Belgium
Aarhus University Hospital
Aarhus, , Denmark
Odense University Hospital
Odense, , Denmark
Vejle Hospital
Vejle, , Denmark
Tartu University Hospital Clinic
Tartu, , Estonia
Helsingin yliopistollinen keskussairaala
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Centre Hospitalier de la cote basque
Bayonne, , France
Hopital Henri Mondor
Créteil, , France
Hopital A. Michallon
La Tronche, , France
CHRU Claude Huriez
Lille, , France
Institut Paoli Calmette Hematologie
Marseille, , France
CHU Hotel Dieu
Nantes, , France
Hopital Saint Antoine
Paris, , France
Service Hemato-Immunologie Hopital St Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Reims
Reims, , France
Hematologie - CHU Purpan
Toulouse, , France
CHRU Hopital Bretonneau
Tours, , France
CHU Nancy Hematology
Vandœuvre-lès-Nancy, , France
Charite, Campus Benjamin Franklin Universitatsmedizin Berlin
Berlin, , Germany
Klinikum Chemnitz
Chemnitz, , Germany
Klinikum der Universitat zu Koln
Cologne, , Germany
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie
Düsseldorf, , Germany
Universitatsklinikum Essen-
Essen, , Germany
Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
Freiburg im Breisgau, , Germany
Abt Haematologie - Onkologie / Allg. Krankenhaus Altona
Hamburg, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Universitatsklinikum Jena
Jena, , Germany
University of Schleswig Holstein
Kiel, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
TU München - Klinikum rechts der Isar
München, , Germany
Universitatsklinik MuensterMedizinische Klinik A
Münster, , Germany
UKT Universitaetsklinikum Tuebingen
Tübingen, , Germany
University Hospital of Ulm
Ulm, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
University of Athens
Athens, , Greece
Cork University HospitalHaematology Consultant
Wilton, Cork, Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Ospedali Riuniti di Ancona
Ancona, , Italy
A.O. Policlinico - Università di Bari
Bari, , Italy
University of Bologna
Bologna, , Italy
Ospedale Ferrarotto
Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milan, , Italy
Universita degli Studi di Padova
Padua, , Italy
Casa di Cura La Maddalena
Palermo, , Italy
Ospedale Civile di Piacenza
Piacenza, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I
Roma, , Italy
Ospedale Sant'Eugenio
Rome, , Italy
Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette
Torino, , Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
Udine, , Italy
Ospedale San Bortolo
Vicenza, , Italy
VU University Medical Center VU Medisch Centrum
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Haga Hospital
The Hague, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Oslo University Hospital, Rikshospitalet HF
Oslo, , Norway
St. Olavs Hospital Trondheim
Trondheim, , Norway
Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii
Gdansk, , Poland
Szpitala Uniwersyteckiego w. Krakowie
Krakow, , Poland
Instytut Hematologii i Transfuzjologii w Warszawie
Warsaw, , Poland
Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra
Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Hospital Geral de Santo António - Serviço de Hematologia Clínica
Porto, , Portugal
University Hospital Bratislava - Hospital Ss Cyril and Methodius
Bratislava, , Slovakia
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona), , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Canarias
La Laguna (Tenerife), , Spain
Hospital de La Princesa
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen De La Victoria
Málaga, , Spain
Hospital Morales Meseguer
Murcia, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital de Donosti
San Sebastián (Guipuzcoa), , Spain
Hospital Clinico Universitario De Santiago De Compostela
Santiago de Compostela, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Universitetssjukhuset i Lund
Lund, , Sweden
Karolinska University HospitalSolna
Stockholm, , Sweden
Universitatsspital Bern
Bern, , Switzerland
Hopitaux Universitaires de Geneve-HUG
Genèva, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Ankara University Medical Faculty Cebeci Hospital
Ankara, , Turkey (Türkiye)
Ege University Medical School
Izmir, , Turkey (Türkiye)
Belfast City Hospital Haematology Department
Belfast Northern Ireland, , United Kingdom
Kent and Canterbury Hospital
Canterbury/Kent, , United Kingdom
Leeds Teaching Hospitals Trust
Leeds, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, , United Kingdom
Newcastle Hospital Foundation Trust
Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital
Sutton (Surrey), , United Kingdom
Southmead Hospital
Westbury-on-Trym/ Bristol, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Rollig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.
Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.
Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.
Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-001888-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-4047-MM-010
Identifier Type: -
Identifier Source: org_study_id
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