Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed and refractory Multiple Myeloma, Pomalidomide, Dexamethasone
Study Type
Interventional
Study Phase
Phase 3
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pomalidomide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Locations
Universitätsklinik Graz
Graz, Austria
Status: Recruiting
Med. Universitat Innsbruck
Innsbruck, Austria
Status: Withdrawn
Muellner Hauptstrasse 48
Salzburg, Austria
Status: Withdrawn
AKH Vienna Waehringer Guertel
Vienna, Austria
Status: Recruiting
Wilhelminenspital Vienna
Vienna, Austria
Status: Recruiting
AZ Sint-Jan Brugge - Oostende AV
Brugge, Belgium
Status: Recruiting
Institut Jules Bordet
Brussels, Belgium
Status: Recruiting
University Hospital Brussels
Brussels, Belgium
Status: Recruiting
University Hospital Gent
Gent, Belgium
Status: Recruiting
University Hospital Leuven
Leuven, Belgium
Status: Recruiting
Centre Hospitalier Universitaire de Liege
Liege, Belgium
Status: Recruiting
CHU Mont Godinne
Yvoir, Belgium
Status: Recruiting
Odense Hospital Hematology Dept
Odense, Denmark
Status: Recruiting
Vejle Hospital Hematology Dept
Vejle, Denmark
Status: Recruiting
Århus University Hospital Tage Hansen gade 2
Århus, Denmark
Status: Recruiting
North Estonian Medical Centre
Tallin, Estonia
Status: Not yet recruiting
Tartu University Hospital clinic
Tartu, Estonia
Status: Recruiting
Helsinki University Hospital Hemat Dept
Helsinki, Finland
Status: Recruiting
Turku University Hospital, Department of Internal. Medicine, Hematology
Turku, Finland
Status: Recruiting
Centre hospitalier de la Cote Basque
Bayonne, France
Status: Recruiting
CHU de Grenoble
La Tronche, France
Status: Not yet recruiting
Chru Lille
Lille, France
Status: Recruiting
Institut Paoli Calmettes
Marseille, France
Status: Recruiting
CHU Hotel Dieu
Nantes, France
Status: Recruiting
CHU Henri Mondor
Paris, France
Status: Not yet recruiting
Hospital Saint-Antoine
Paris, France
Status: Recruiting
Hospital Saint-Louis
Paris, France
Status: Not yet recruiting
CHLS
Pierre-Benite, France
Status: Recruiting
CHU Reims, Hospital Robert Debre
Reims, France
Status: Not yet recruiting
Hospital Purpan (Toulouse)
Toulouse, France
Status: Not yet recruiting
Hospital Bretonneau - CHU Tours
Tours, France
Status: Recruiting
CHU Nancy - Brabois
Vandoeuvre, France
Status: Recruiting
Medizinische Klinik III
Berlin, Germany
Status: Recruiting
Klinikum Chemnitz GmbH
Chemnitz, Germany
Status: Recruiting
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Status: Recruiting
Universitatsklinikum Dusseldorf
Dusseldorf, Germany
Status: Recruiting
Universitatsklinikum Essen, Klinik fur Hamatologie
Essen, Germany
Status: Recruiting
AK Altona
Hamburg, Germany
Status: Recruiting
Universitatsklinikum Heidelberg
Heidelberg, Germany
Status: Recruiting
Medizinische Klinik
Hugstetten, Germany
Status: Recruiting
Universitatsklinikum Jena
Jena, Germany
Status: Recruiting
UK Schleswig-Holstein Campus Kiel
Kiel, Germany
Status: Recruiting
Klinikum der Universität zu Köln
Koln, Germany
Status: Recruiting
Universitatsklinikum Leipzig
Leipzig, Germany
Status: Withdrawn
Universitatsklinikum Munster
Munster, Germany
Status: Withdrawn
Klinikum rechts der Isar der TU München
München, Germany
Status: Recruiting
Universitatsklinikum Tubingen
Tubingen, Germany
Status: Recruiting
Universitatsklinikum Ulm
Ulm, Germany
Status: Recruiting
Universitatsklinikum Wurzburg
Wurzburg, Germany
Status: Recruiting
University Of Athens
Athens, Greece
Status: Recruiting
Cork University Hospital - CUH
Cork, Ireland
Status: Recruiting
Mater Misericordiae
Dublin, Ireland
Status: Recruiting
University College Hospital Galway and Clinical Research facility Galway
Galway, Ireland
Status: Recruiting
Ospedali Riuniti - Umberto I, Lancisi, Salesi
Ancona, Italy
Status: Recruiting
Pliclinico di Bari
Bari, Italy
Status: Recruiting
Instituto di Ematologia ed Oncologia Medica Seragnoli di Bologna
Bologna, Italy
Status: Recruiting
Ospedale Ferrarotto
Catania, Italy
Status: Recruiting
Fondazione IRCCS Istituto Nazionale dei Timori
Milano, Italy
Status: Recruiting
Università degli Studi di Padova
Padova, Italy
Status: Not yet recruiting
Casa di Cura La Maddalena
Palermo, Italy
Status: Recruiting
U.O. di Ematologia e Centro Trapianto
Piacenza, Italy
Status: Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy
Status: Recruiting
Policlinico S.Eugenio
Roma, Italy
Status: Recruiting
Policlinico Umberto I, Università "La Sapienza" di Roma
Roma, Italy
Status: Recruiting
A.O.U. San Giovanni Battista
Torino, Italy
Status: Recruiting
Universita degli Studi Policlinico
Udine, Italy
Status: Recruiting
S. Bortolo Hospital
Vicenza, Italy
Status: Recruiting
VU medisch centrum
Amsterdam, Netherlands
Status: Not yet recruiting
VU medisch centrum,De Boelelaan 117
Amsterdam, Netherlands
Status: Recruiting
HAGA Hospital
Den Haag, Netherlands
Status: Recruiting
Universitair Medisch Centrum
Groningen, Netherlands
Status: Not yet recruiting
Universitair Medisch Centrum, Hanzeplein 1
Groningen, Netherlands
Status: Recruiting
Erasmus Medical Center
Rotterdam, Netherlands
Status: Recruiting
University Medical Center
Utrecht, Netherlands
Status: Recruiting
Oslo University Hospital, Rikshospitalet HF
Oslo, Norway
Status: Recruiting
St. Olav Hospital
Trondheim, Norway
Status: Recruiting
Akademia Medyczna w Gdańsku
Gdańsk, Poland
Status: Not yet recruiting
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Status: Not yet recruiting
Instytut Hematologii i Transfuzjologii
Warszawa, Poland
Status: Not yet recruiting
Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal
Status: Withdrawn
Instituto Portugues de Oncologia de Lisboa Francisco
Lisboa, Portugal
Status: Recruiting
Hospital de Santa Maria
Lisbon, Portugal
Status: Recruiting
Hospital de Santo António
Porto, Portugal
Status: Recruiting
University hospital Bratislava
Bratislava, Slovakia
Status: Not yet recruiting
University hospital Martin
Martin, Slovakia
Status: Withdrawn
Clinical Center Ljubljana
Ljubljana, Slovenia
Status: Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Status: Recruiting
Hospital Germans Trials i Pujol Servicio Hematologia
Barcelona, Spain
Status: Recruiting
Hospital 12 de Octubre
Madrid, Spain
Status: Recruiting
Hospital Clínico San Carlos
Madrid, Spain
Status: Recruiting
Hospital de la Princesa
Madrid, Spain
Status: Recruiting
Hospital Universitario Ramon y Cajal
Madrid, Spain
Status: Recruiting
Hospital Morales Meseguer
Murcia, Spain
Status: Recruiting
Hospital Vírgen de la Victoria Servicio Hematología
Málaga, Spain
Status: Recruiting
Clinica Universidad de Navarra
Pamplona, Spain
Status: Recruiting
Hospital Universitario de Salamanca
Salamanca, Spain
Status: Recruiting
Hospital Universitario de Donostia
San Sebastian, Spain
Status: Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Status: Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela La Coruña, Spain
Status: Recruiting
Hospital Virgen de la Salud
Toledo, Spain
Status: Not yet recruiting
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Status: Recruiting
Hospital Miguel Servet
Zaragoza, Spain
Status: Recruiting
Skane University Hospital
Lund, Sweden
Status: Recruiting
Karolinska University Hospital Solna
Stockholm, Sweden
Status: Recruiting
University Hospital Oncology
Bern, Switzerland
Status: Recruiting
Geneva University Hospital Oncology
Geneva, Switzerland
Status: Recruiting
USZ - UniversitatsSpital Zurich
Zurich, Switzerland
Status: Recruiting
Ankara University Medical Faculty
Ankara, Turkey
Status: Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey
Status: Not yet recruiting
Ege University Medical Faculty
Izmir, Turkey
Status: Not yet recruiting
Belfast City Hospital
Belfast Northern Ireland, United Kingdom
Status: Recruiting
Southmead Hospital
Bristol, United Kingdom
Status: Recruiting
Kent and Canterbury Hospital
Canterbury, United Kingdom
Status: Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds West Yorkshire, United Kingdom
Status: Recruiting
Royal Liverpool University Hospital
Liverpool, United Kingdom
Status: Recruiting
The Christie NHS Foundation Trust
Manchester, United Kingdom
Status: Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Status: Recruiting
The Royal Marsden NHS Trust
Sutton, United Kingdom
Status: Recruiting
New Cross Hospital
Wolverhampton, United Kingdom
Status: Recruiting
Start Date
November 2012
Completion Date
March 2020
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page