Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma

NCT ID: NCT01818752

Last Updated: 2019-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

955 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-08

Study Completion Date

2016-11-04

Brief Summary

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The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carfilzomib, Melphalan, Prednisone

Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

Group Type EXPERIMENTAL

Carfilzomib

Intervention Type DRUG

Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.

Melphalan

Intervention Type DRUG

Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.

Prednisone

Intervention Type DRUG

Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.

Bortezomib, Melphalan, Prednisone

Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

Group Type ACTIVE_COMPARATOR

Bortezomib

Intervention Type DRUG

Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.

Melphalan

Intervention Type DRUG

Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.

Prednisone

Intervention Type DRUG

Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.

Interventions

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Carfilzomib

Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.

Intervention Type DRUG

Bortezomib

Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.

Intervention Type DRUG

Melphalan

Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.

Intervention Type DRUG

Prednisone

Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.

Intervention Type DRUG

Other Intervention Names

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Krypolis® Velcade®

Eligibility Criteria

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Inclusion Criteria

1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group \[IMWG\] diagnostic criteria)
2. Transplant ineligibility
3. Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization):

* Serum M-protein ≥ 0.5 g/dL, or
* Urine M-protein ≥ 200 mg/24 hours, or
* In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio \< 0.26 or \> 1.65)
4. No prior treatment for multiple myeloma
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria

1. Multiple myeloma of IgM (immunoglobulin M) subtype
2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
4. Plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
5. Waldenström macroglobulinemia (WM)
6. Known amyloidosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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California Cancer Associates for Research & Excellence, Inc. (cCARE)

Fresno, California, United States

Site Status

Marin Cancer Care

Greenbrae, California, United States

Site Status

Sutter Gould Medical Foundation

Modesto, California, United States

Site Status

Innovative Clinical Research Institute

Whittier, California, United States

Site Status

UF Health Shands Cancer Hospital

Gainesville, Florida, United States

Site Status

Evanston KelIogg Cancer Center

Evanston, Illinois, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Maimonides Cancer Center

Brooklyn, New York, United States

Site Status

Weill Cornell Medical Center

New York, New York, United States

Site Status

Gabrail Cancer Center Research

Canton, Ohio, United States

Site Status

Saint Francis Health System

Greenville, South Carolina, United States

Site Status

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, United States

Site Status

Santee Hematology Oncology

Sumter, South Carolina, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)

Buenos Aires, , Argentina

Site Status

Sanatorio Britanico S.A.

Santa Fe, , Argentina

Site Status

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status

Central Coast Local Health District

North Gosford, New South Wales, Australia

Site Status

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Eastern Health - Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Border Medical Oncology

Wodonga, Victoria, Australia

Site Status

Royal North Shore Hospital, Haematology Department

New South Wales, , Australia

Site Status

Medical University of Innsbruck, University Clinic for Internal Medicine V

Innsbruck, , Austria

Site Status

Elisabeth Linz Hospital

Linz, , Austria

Site Status

Vienna Wilhelminen Hospital

Vienna, , Austria

Site Status

ZNA, Stuivenberg

Antwerp, Antwerpen, Belgium

Site Status

Saint Joseph Clinic Arlon, Department of Hematology

Arlon, Luxembourg, Belgium

Site Status

CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)

Liège, , Belgium

Site Status

CHU Mont-Godinne

Yvoir, , Belgium

Site Status

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic

Plovdiv, , Bulgaria

Site Status

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic

Plovdiv, , Bulgaria

Site Status

Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic

Sofia, , Bulgaria

Site Status

Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic

Sofia, , Bulgaria

Site Status

Multiprofile Hospital for Active Treatment "Sveta Marina", Varna

Varna, , Bulgaria

Site Status

CSSS-Champlain-Charles LeMoyne

Greenfield Park, Quebec, Canada

Site Status

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

The First Affiliated Hospital of the Fourth Military Medical University of PLA

Xi’an, Shanxi, China

Site Status

The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin

Hangzhou, Zhejiang, China

Site Status

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

307 Hospital of PLA

Beijing, , China

Site Status

Beijing Chao Yang Hospital, Capital Medical University

Beijing, , China

Site Status

Peking Union Medical College Hospital

Beijing, , China

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Shanghai Changzheng Hospital

Shanghai, , China

Site Status

Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University

Tianjin, , China

Site Status

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status

University Hospital Brno, Department of Internal Hematology and Oncology

Brno, , Czechia

Site Status

University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis

Brno, , Czechia

Site Status

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status

University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology

Olomouc, , Czechia

Site Status

University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO

Ostrava, , Czechia

Site Status

University Hospital Kralovske Vinohrady - Internal Hematology Clinic

Prague, , Czechia

Site Status

General University Hospital Prague, 1st Department of Medicine - Department of Hematology

Prague, , Czechia

Site Status

CHU de Caen, Côte de Nacre

Caen, , France

Site Status

CHU Estaing

Clermont-Ferrand, , France

Site Status

UHC Dijon, Children's Hospital

Dijon, , France

Site Status

CHRU Lille Hôpital Claude Huriez

Lille, , France

Site Status

CHRU Hopital Huriez, Departement of Hematology

Lille, , France

Site Status

Paoli Calmettes Institute, Department ofHematology 2

Marseille, , France

Site Status

Nantes University Hospital Center

Nantes, , France

Site Status

Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau

Nîmes, , France

Site Status

Hopital Saini Louis, Service d'immuno-Hematologie

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hospital Necker

Paris, , France

Site Status

South Lyon Hospital Center

Pierre-Bénite, , France

Site Status

Centre Hospitalier Lyon Sud, Service d'hématologie Clinique

Pierre-Bénite, , France

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Hopital Pontchaillou

Rennes, , France

Site Status

Hospital Purpan

Toulouse, , France

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CHU de Tours Hopital Bretonneau

Tours, , France

Site Status

Freiburg University Medical Center

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III

Ulm, Baden-Wurttemberg, Germany

Site Status

Ludwig Maximilians University Hospital - Medical Clinic III

Munich, Bavaria, Germany

Site Status

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III

Mainz, Rhineland-Palatinate, Germany

Site Status

Saarland University Hospital

Homburg / Saar, Saarland, Germany

Site Status

Group Practice for Hematology and Oncology

Dresden, , Germany

Site Status

Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine

Koblenz, , Germany

Site Status

Evangelismos Hospital

Athens, Attica, Greece

Site Status

University of Athens, Alexandra Hospital

Athens, , Greece

Site Status

St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant

Budapest, , Hungary

Site Status

National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology

Budapest, , Hungary

Site Status

University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology

Debrecen, , Hungary

Site Status

Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology

Gyula, , Hungary

Site Status

Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology

Kaposvár, , Hungary

Site Status

Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine

Kecskemét, , Hungary

Site Status

Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

Pécs, , Hungary

Site Status

Soroka University Medical Center

Beersheba, , Israel

Site Status

Rambam Medical Center, Department of Hematology

Haifa, , Israel

Site Status

Ein Kerem Hospital, Department of Hematology

Jerusalem, , Israel

Site Status

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

UO Clinica Ematologica, IRCCS A.O.U. San Martino

Genova, GE, Italy

Site Status

A.O.U. San Luigi Gonzaga

Orbassano, TO, Italy

Site Status

Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi

Ancona, , Italy

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Maggiore della Carita Hospital of Novara

Novara, , Italy

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Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema

Piacenza, , Italy

Site Status

Ospedale S. Eugenio

Roma, , Italy

Site Status

Policlinico Universitario "Umberto I"

Rome, , Italy

Site Status

AO Città della Salute e della Scienza di Torino, Division of Hematology

Torino, , Italy

Site Status

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Site Status

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status

National Hospitalization Organization Kyushu Cancer Center

Minamiku, Fukuoka, Japan

Site Status

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

Site Status

Gunma University Hospital

Maebashi, Gunma, Japan

Site Status

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Site Status

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, Japan

Site Status

Osaka University Hospital

Suita, Osaka, Japan

Site Status

Japanese Red Cross Medical Center

Tokyo, Shibuya-ku, Japan

Site Status

Tochigi Cancer Center

Utsunomiya, Tochigi, Japan

Site Status

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Koto, Tokyo, Japan

Site Status

National Center for Global Health and Medicine

Shinjuku, Tokyo, Japan

Site Status

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, Japan

Site Status

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Tokushima Prefectural Central Hospital

Tokushima, , Japan

Site Status

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Site Status

Fundacion Centro Oncologieo de Integracion Regional - COIR

Mendoza, , Mexico

Site Status

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, , Mexico

Site Status

Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles

Puebla City, , Mexico

Site Status

Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology

Amsterdam, , Netherlands

Site Status

St. Antonius Ziekenhuis, Department of Hematology

Nieuwegein, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Isala Clinics in Zwolle, Department of Oncology

Zwolle, , Netherlands

Site Status

North Shore Hospital

Auckland, , New Zealand

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Canterbury Health Laboratories

Christchurch, , New Zealand

Site Status

Wellington Hospital

Wellington, , New Zealand

Site Status

Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn

Olsztyn, OIsztyn, Poland

Site Status

Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology

Chorzów, Silesian Voivodeship, Poland

Site Status

Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice

Katowice, , Poland

Site Status

Independent Public Healthcare Facility University Hospital

Krakow, , Poland

Site Status

Nicolaus Copernicus Memorial Provincial Specialist Hospital

Lodz, , Poland

Site Status

Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology

Lublin, , Poland

Site Status

Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology

Torun, , Poland

Site Status

Maria Sklodowska-Curie Institute of Oncology

Warsaw, , Poland

Site Status

"Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department

Cluj-Napoca, Cluj, Romania

Site Status

Iasi Regional Institute for Oncology, Medical Hematology Department

Iași, Iaşi, Romania

Site Status

Brasov County Emergency Clinical Hospital, Hematology Department

Brasov, , Romania

Site Status

Fundeni Clinical Institute, Hematology Department

Bucharest, , Romania

Site Status

Coltea Clinical Hospital, Hematology Department

Bucharest, , Romania

Site Status

Bucharest Emergency University Hospital, Hematology Department

Bucharest, , Romania

Site Status

Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation

Târgu Mureş, , Romania

Site Status

State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology

Petrozavodsk, Republic of Karelia, Russia

Site Status

Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2

Arkhangelsk, , Russia

Site Status

State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

Izhevsk, , Russia

Site Status

Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences

Moscow, , Russia

Site Status

City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

Moscow, , Russia

Site Status

Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care

Saint Petersburg, , Russia

Site Status

City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

Saint Petersburg, , Russia

Site Status

State Higher Educational Institution St. Petersburg Pavlov State Medical University

Saint Petersburg, , Russia

Site Status

The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian

Saint Petersburg, , Russia

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

Singapore Oncology Consultants, Gleneagles Hospital

Singapore, , Singapore

Site Status

OncoCare Cancer Center

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, Barselona, Spain

Site Status

University Hospital of Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Clinic i Provincial Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario 12 De Octubre

Madrid, , Spain

Site Status

Hospital Universitario, Salamanca

Salamanca, , Spain

Site Status

Hospital Virgen del Rocio University

Seville, , Spain

Site Status

Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología

Valencia, , Spain

Site Status

Hospital Quiron Zaragoza

Zaragoza, , Spain

Site Status

University Hospital Center Vaudois

Lausanne, , Switzerland

Site Status

County Hospital Saint Gallen

Sankt Gallen, , Switzerland

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Kuohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Chang-Gung Memorial Hospital, Linkou

Tapei, , Taiwan

Site Status

Ege University Medical Faculty

Izmir, Bornova, Turkey (Türkiye)

Site Status

Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department

Ankara, Cebeci, Turkey (Türkiye)

Site Status

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, Turkey (Türkiye)

Site Status

Cherkasy Regional Oncology Center

Cherkasy, , Ukraine

Site Status

Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre

Dnipropetrovsk, , Ukraine

Site Status

Kharkiv Regional Clinical Oncology Center, Department of Hematology

Kharkiv, , Ukraine

Site Status

Khmelnytskyi Regional Hospital, Hematology Department

Khmelnytskyi, , Ukraine

Site Status

Kyiv Center for Bone Marrow Transplantation

Kyiv, , Ukraine

Site Status

Institute of Blood Pathology and Transfusion Medicine

Lviv, , Ukraine

Site Status

Poltava M.V. Sklifosovskyi Regional Clinical-Hospital

Poltava, , Ukraine

Site Status

A. Novak Zakarpattia Regional Clinical Hospital

Uzhhorod, , Ukraine

Site Status

M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department

Vinnitsya, , Ukraine

Site Status

O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center

Zhytomyr, , Ukraine

Site Status

Kent and Canterbury Hospital

Canterbury, Kent, United Kingdom

Site Status

Maidstone Hospital, Kent Oncology Centre

Maidstone, Kent, United Kingdom

Site Status

Northwick Park Hospital

Harrow, Middlesex, United Kingdom

Site Status

Raigmore Hospital

Inverness, , United Kingdom

Site Status

University College London, Cancer Centre

London, , United Kingdom

Site Status

Guy's and St. Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Oxford University Hospitals NHS Trust, Churchill Hospital

Oxford, , United Kingdom

Site Status

The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital

Wolverhampton, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Bulgaria Canada China Czechia France Germany Greece Hungary Israel Italy Japan Mexico Netherlands New Zealand Poland Romania Russia Singapore South Korea Spain Switzerland Taiwan Turkey (Türkiye) Ukraine United Kingdom

References

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Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.

Reference Type BACKGROUND
PMID: 29991494 (View on PubMed)

Facon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.

Reference Type BACKGROUND
PMID: 30819926 (View on PubMed)

Rosenthal A, Luthi J, Belohlavek M, Kortum KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6(1):e384. doi: 10.1038/bcj.2015.112.

Reference Type DERIVED
PMID: 26771810 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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2012-005283-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20130397

Identifier Type: OTHER

Identifier Source: secondary_id

2012-005

Identifier Type: -

Identifier Source: org_study_id

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