Spots Global Cancer Trial Database for Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
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Trial Identification
Brief Title: Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
Official Title: A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Study ID: NCT03110562
Conditions
Study Description
Brief Summary: This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Boca Raton Clinical Research (BRCR) Medical Center, Plantation, Florida, United States
Emory University, Atlanta, Georgia, United States
Kaiser Permanente Hawaii, Honolulu, Hawaii, United States
McFarland Clinic, Ames, Iowa, United States
Stormont Vail Health Care (Cotton O'Neil Cancer Center ), Topeka, Kansas, United States
Commonwealth Hematology, Danville, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland, Baltimore, Maryland, United States
Central Care Cancer Center, Bolivar, Missouri, United States
The Valley Hospital Luckow Pavilion, Paramus, New Jersey, United States
Mount Sinai, New York, New York, United States
The Cancer Institute at St. Francis Hospital, Roslyn, New York, United States
Novant-Forsyth Memorial Hospital, Winston-Salem, North Carolina, United States
University of Cincinnati Health, Cincinnati, Ohio, United States
Southwest Cancer Center of Oklahoma, Lawton, Oklahoma, United States
Kaiser Permanente Northwest OR, Portland, Oregon, United States
SCOR AnMed Health Cancer Center, Anderson, South Carolina, United States
Prairie Lakes Healthcare, Watertown, South Dakota, United States
Baylor Sammons Cancer Center, Dallas, Texas, United States
University of Texas Southwestern, Dallas, Texas, United States
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Mater Misericordiae Limited and Mater Medical Research, South Brisbane, Queensland, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology), Innsbruck, , Austria
University Hospital Krems, Department of Internal Medicine II, Krems, , Austria
Medical University of Vienna, Vienna, , Austria
General Hospital Hietzing, Vienna, , Austria
Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology, Vienna, , Austria
Jules Bordet Institute, Brussels, , Belgium
UCL Saint-Luc, Brussels, , Belgium
University Hospital Ghent, Ghent, , Belgium
General Hospital Delta, Roeselare, , Belgium
St. Augustinus Hospital, Wilrijk, , Belgium
University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology, Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology, Sofia, , Bulgaria
Tom Baker Cancer Center/ Alberta Health Services, Calgary, Alberta, Canada
Cross Cancer Institute / University of Alberta, Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada
North East Cancer Centre Sudbury, Sudbury, Ontario, Canada
Princess Margaret Cancer Research, Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Royal Victoria Hospital / McGill University, Montreal, Quebec, Canada
L'Hôtel-Dieu de Québec, Quebec City, Quebec, Canada
Saskatchewan Cancer Agency-Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada
General University Hospital in Prague, Praha 2, Prague, Czechia
University Hopsital Brno, Brno, , Czechia
University Hospital Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
University Hospital Ostrava, Dept. of Hematooncology, Ostrava, , Czechia
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology, Prague, , Czechia
Necker Children's Hospital, Department of Adult Hematology, Paris, Ile De France, France
Hospital Center Departmental La Roche-Sur-Yon, La Roche-sur-Yon, , France
Claude Huriez Hospital, Lille, , France
South Lyon Hospital Center, Lyon, , France
Brabois Adults Hospital, University Hospital Center of Nancy, Nancy, , France
Nantes University Hospital Center, Nantes, , France
Saint-Louis Hospital, Paris, , France
Miletrie Hospital, University Hospital Center of Poitiers, Poitiers, , France
University Hospital Freiburg, Department of Internal Medicine I, Freiburg, Baden-Wuerttemberg, Germany
Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3, Leverkusen, North Rhine Westfalia, Germany
Group Practice for Hematology and Oncology, Dresden, Saxony, Germany
Alexandra General Hospital, Therapeutic Clinic, Athens, , Greece
General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma, Athens, , Greece
University General Hospital of Patra, Pátra, , Greece
Theageneion Cancer Hospital, Hematology Department, Thessaloníki, , Greece
Semmelweis University, 1st Department of Internal Medicine, Budapest, , Hungary
Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation, Budapest, , Hungary
Semmelweis University, 3rd Department of Internal Medicine, Budapest, , Hungary
Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine, Kaposvar, , Hungary
Medical Center of the University of Pecs, Department of Hematology, Pecs, , Hungary
Regional Cancer Centre, Patna, Bihar, India
Regional Cancer Centre, Thiruvananthapuram, Kerala, India
Prince Aly Khan Hospital, Mumbai, Maharashta, India
Jaslok Hospital and Research Centre, Mumbai, Maharashta, India
Bhaktivedanta Hospital, Thane, Maharashtra, India
IMS & SUM Hospital, Bhubaneswar, Odisha, India
Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, Punjab, India
Dayanand Medical College & Hospital, Ludhiana, Punjab, India
Cancer Institute, Chennai, Tamil Nadu, India
SRM Institute of Medical Sciences, Chennai, Tamil Nadu, India
Saveetha Medical College Hospital, Chennai, Tamil Nadu, India
G. Kuppuswamy Naidu Hospital, Coimbatore, Tamil Nadu, India
Asviratham Speciality Hospital, Madurai, Tamil Nadu, India
Meenakshi Mission Hospital, Madurai, Tamil Nadu, India
Yashoda Hospital, Hyderabad, Telengana, India
King George's Medical University, Lucknow, Uttar Pradesh, India
Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata, West Bengal, India
Nil Ratan Sircar (NRS) Medical College, Kolkata, West Bengal, India
TATA Memorial Centre, Kolkata, West Bengal, India
Rajiv Gandhi Cancer Hospital, New Delhi, , India
Barzilai Medical Center, Ashkelon, , Israel
Rambam Health Care Campus, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petaẖ Tiqwa, , Israel
Hospital Santa Maria of Terni, Terni, Umbria, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, , Italy
ASST Papa Giovanni XXIII, Bergamo, , Italy
Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo, Bologna, , Italy
University Hospital Careggi, Department of Hematology, Florence, , Italy
University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology, Genoa, , Italy
Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit, Milan, , Italy
Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center, Rome, , Italy
University Hospital San Giovanni Battista of Turin, Turin, , Italy
Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology, Bydgoszcz, , Poland
Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology, Chorzow, , Poland
University Hospital in Krakow, Teaching Unit of the Hematology Department, Krakow, , Poland
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation, Lublin, , Poland
St. John of Dukla Oncology Center of Lublin, Department of Hematology, Lublin, , Poland
Military Institute of Medicine, Department of Internal Medicine and Hematology, Warsaw, , Poland
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology, Łódź, , Poland
Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department, Braşov, , Romania
Colentina Clinical Hospital, Department of Hematology, Bucharest, , Romania
Bucharest University Emergency Hospital, Department of Hematology, Bucharest, , Romania
S.P. Botkin City Clinical Hospital, Moscow, , Russian Federation
N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways, Moscow, , Russian Federation
First I.P. Pavlov State Medical University of St. Petersburg, Saint Petersburg, , Russian Federation
V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1, Saint Petersburg, , Russian Federation
Clinical Center of Serbia, Clinic of Hematology, Belgrade, , Serbia
Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology, Belgrade, , Serbia
Clinical Center Kragujevac, Clinic of Hematology, Kragujevac, , Serbia
Clinical Center Nis, Clinic of Hematology and Clinical Immunology, Nis, , Serbia
Clinical Center of Vojvodina, Clinic of Hematology, Novi Sad, , Serbia
University Hospital of the Canary Islands, La Laguna, Santa Cruz De Tenerife, Spain
Catalan Institute of Oncology (ICO) Badalona, Badalona, , Spain
University Hospital of Vall d'Hebron, Barcelona, , Spain
University Hospital Infanta Leonor, Department of Hematology, Madrid, , Spain
University Clinical Hospital of Salamanca, Department of Hematology, Salamanca, , Spain
University Hospital Virgen del Rocio (HUVR), Seville, , Spain
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology, Cherkasy, , Ukraine
City Clinical Hospital No.4 of Dnipro City Council, City hematology center, Dnipropetrovsk, , Ukraine
BMT Kiev Center, Kiev, , Ukraine
Kiev Cancer Institute, Kiev, , Ukraine
Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group, Lviv, , Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology, Vinnytsia, , Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards, Zhytomyr, , Ukraine
Belfast Heatlh & Social Care Trust Belfast City Hospital, Belfast, Northern Ireland, United Kingdom
NHS Tayside Ninewells Hospital, Dundee, Scotland, United Kingdom
Cardiff & Vale University Health Board University Hospital of Wales, Cardiff, Wales, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital, Birmingham, , United Kingdom
The Leeds Teaching Hospitals NHS Trust St. James University Hospital, Leeds, , United Kingdom
University Hospitals of Leicester NHS Trust Royal Leicester Infirmary, Leicester, , United Kingdom
Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital, Liverpool, , United Kingdom
London North West Healthcare NHS Trust Northwick Park Hospital, London, , United Kingdom
University College London, London, , United Kingdom
King's College Hospital NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Freeman Hospital, Newcastle Upon Tyne, , United Kingdom
The Royal Wolverhampton NHS Trust New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
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