Spots Global Cancer Trial Database for Efficacy and Safety of Pomalidomide and Dexamethasone in RRMM Patients With Renal Insufficiency
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Trial Identification
Brief Title: Efficacy and Safety of Pomalidomide and Dexamethasone in RRMM Patients With Renal Insufficiency
Official Title: A Phase 2 Multicenter, Open-label Study to Determine the Efficacy and Safety of Pomalidomide (CC-4047) in Combination With Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Moderate or Severe Renal Impairment Including Subjects Undergoing Hemodialysis
Study ID: NCT02045017
Conditions
Interventions
Study Description
Brief Summary: The primary purpose of the study is to determine the safety and efficacy and to generate PK and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.
Detailed Description: The study will consist of a Screening phase within 28 days prior to cycle 1 day 1. Subjects once enrolled will enter the Treatment phase, in which patients will be treated until progression, or study discontinuation due to other reasons. Subjects will enter the long term Follow-up phase of the study where data will be collected every 3 months for up to 5 years on Secondary primary malignancies, survival, subsequent anti myeloma treatments and date of progression. Subjects will be recruited into one of 3 cohorts depending on the severity of their renal impairment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Krankenhaus der Elisabethinen Linz, I Interne Abteilung, Linz, , Austria
Medizinische Universitat Wien, Wien, , Austria
Wilhelminenspital der Stadt Wien, Wien, , Austria
Hopital Dypuytren-CHU de Limoges, Limoges cedex, , France
Hopital Saint Louis, Paris, , France
CHU de Poitiers, Poitiers, , France
Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie, Neuenheimer Feld 410, , Germany
University Hospital Tubingen, Tubingen, , Germany
Alexandra Hospital, University of Athens, Athens, , Greece
Azienda Ospedaliero Universitaria Ospedali, Ancona, , Italy
S.C. Oncologia Medica, Lecco, , Italy
Ospedale Maggiore Policlinico Mangiagalli Regina Elena, Milano, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
VU University Medical Center VU Medisch Centrum, Amsterdam, , Netherlands
Daniel den Hoed Kliniek Medical Oncology, Erasmus MC, Rotterdam, , Netherlands
Hospital de La Princesa, Madrid, , Spain
CEIC Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Doctor Peset, Valencia, , Spain
Queen Elizabeth Hospital UHB NHS Foundation Trust, Birmingham, , United Kingdom
Ninewells Hospital and Medical School, Dundee, , United Kingdom
Oxford Radcliffe Hospital ICRF Medical Oncology Unit, Headington, , United Kingdom
St Thomas' HospitalGuy's Hospital Dept. of Haematology, London, , United Kingdom
Contact Details
Name: Elisabeth Kueenburg, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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