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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01712789
Other study ID # CC-4047-MM-010
Secondary ID 2012-001888-78
Status Completed
Phase Phase 3
First received
Last updated
Start date November 6, 2012
Est. completion date December 11, 2019

Study information

Verified date December 2021
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. 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.


Recruitment information / eligibility

Status Completed
Enrollment 682
Est. completion date December 11, 2019
Est. primary completion date December 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients =18 years old, who must understand and voluntarily sign an Informed Consent. - 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: - Prior history of malignancies, other than Multiple Myeloma. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Austria Medical University of Graz Graz
Austria Medizinische Universitat Innsbruck Innsbruck
Austria Medical University of Vienna Vienna
Austria Wilhelminenspital Vienna Vienna
Belgium AZ St-Jan Brugge Oostende AV Brugge
Belgium VUB Vrije Universiteit Brussel Brussel
Belgium Institut Jules Bordet Brussels
Belgium UZ Gent Gent
Belgium UZ Leuven Leuven
Belgium Centre Hospitalier Universitaire de Liege Liege
Belgium CHU Mont -Godinne Yvoir
Denmark Aarhus University Hospital Aarhus
Denmark Odense University Hospital Odense
Denmark Vejle Hospital Vejle
Estonia Tartu University Hospital Clinic Tartu
Finland Helsingin yliopistollinen keskussairaala Helsinki
Finland Turku University Hospital Turku
France 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 cedex
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 cedex
France Hematologie - CHU Purpan Toulouse
France CHRU Hopital Bretonneau Tours cedex
France CHU Nancy Hematology Vandoeuvre les Nancy
Germany Charite, Campus Benjamin Franklin Universitatsmedizin Berlin Berlin
Germany Klinikum Chemnitz Chemnitz
Germany Universitatsklinikum Carl Gustav Carus Dresden
Germany Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie Dusseldorf
Germany Universitatsklinikum Essen- Essen
Germany Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik Freiburg
Germany Abt Haematologie - Onkologie / Allg. Krankenhaus Altona Hamburg
Germany Universitatsklinikum Heidelberg Heidelberg
Germany Universitatsklinikum Jena Jena
Germany University of Schleswig Holstein Kiel
Germany Klinikum der Universitat zu Koln Köln
Germany Universitatsklinikum Leipzig Leipzig
Germany Universitatsklinik MuensterMedizinische Klinik A Muenster
Germany TU München - Klinikum rechts der Isar München
Germany UKT Universitaetsklinikum Tuebingen Tuebingen
Germany University Hospital of Ulm Ulm
Germany Universitatsklinikum Wurzburg Würzburg
Greece University of Athens Athens
Ireland Mater Misericordiae University Hospital Dublin
Ireland University Hospital Galway Galway
Ireland Cork University HospitalHaematology Consultant Wilton Cork
Italy Ospedali Riuniti di Ancona Ancona
Italy A.O. Policlinico - Università di Bari Bari
Italy University of Bologna Bologna
Italy Ospedale Ferrarotto Catania
Italy ASST Grande Ospedale Metropolitano Niguarda, Milano Milano
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Italy Universita degli Studi di Padova Padova
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
Netherlands VU University Medical Center VU Medisch Centrum Amsterdam
Netherlands Haga Hospital Den Haag
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht
Norway Oslo University Hospital, Rikshospitalet HF Oslo
Norway St. Olavs Hospital Trondheim Trondheim
Poland Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii Gdansk
Poland Szpitala Uniwersyteckiego w. Krakowie Kraków
Poland Instytut Hematologii i Transfuzjologii w Warszawie Warszawa
Portugal Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra Coimbra
Portugal Hospital de Santa Maria Lisboa
Portugal Instituto Portugues de Oncologia de Lisboa Lisboa
Portugal Hospital Geral de Santo António - Serviço de Hematologia Clínica Porto
Slovakia University Hospital Bratislava - Hospital Ss Cyril and Methodius Bratislava
Spain 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 12 de Octubre Madrid
Spain Hospital Clinico San Carlos Madrid
Spain Hospital de La Princesa Madrid
Spain Hospital Ramon y Cajal Madrid
Spain Hospital Universitario Virgen De La Victoria Malaga
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
Sweden Universitetssjukhuset i Lund Lund
Sweden Karolinska University HospitalSolna Stockholm
Switzerland Universitatsspital Bern Bern
Switzerland Hopitaux Universitaires de Geneve-HUG Genèva
Switzerland University Hospital Zurich Zurich
Turkey Ankara University Medical Faculty Cebeci Hospital Ankara
Turkey Ege University Medical School Izmir
United Kingdom 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

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (4)

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, Röllig 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2016 Jun 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent Adverse Events (TEAE) An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.
A SAE = AE occurring at any dose that:
Results in death;
Is life-threatening
Requires inpatient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.
Secondary Overall Response Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
Secondary Time to Response Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria. Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
Secondary Kaplan Meier Estimate of Duration of Response Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment. From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Secondary Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted. From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Secondary Kaplan Meier Estimate of Time to Progression Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted). From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Secondary Kaplan Meier Estimate of Overall Survival (OS) Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive. From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Secondary Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F) Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data. Cycles 1, 2, 3, 4, 5, 6
Secondary Pomalidomide Exposure - Apparent Volume of Distribution (V/F) Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data. Cycles 1, 2, 3, 4, 5, 6
Secondary Cytogenetic Analysis Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome. Study entry
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