Phase 3 Study With Carfilzomib and Dexamethasone Versus Velcade and Dexamethasone for Relapsed Multiple Myeloma Patients (ENDEAVOR)

This study is currently recruiting participants.
Verified March 2014 by Onyx Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01568866
First received: March 28, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This Phase 3 study is a multicenter, open-label, randomized trial in patients with multiple myeloma whose disease has relapsed after at least 1 but not more than 3 prior therapeutic regimens. Patients must not have primary refractory disease (i.e., stable disease or progressive disease [PD] as best response to all prior therapies). Patients are allowed to have received prior carfilzomib or Velcade as long as they had at least a PR to prior therapy with carfilzomib or Velcade and at least a 6 month treatment-free interval since receiving carfilzomib or Velcade. Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month treatment-free interval.


Condition Intervention Phase
Multiple Myeloma
Drug: Carfilzomib plus dexamethasone
Drug: Velcade plus dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Onyx Pharmaceuticals:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    To compare Progression Free Survival (PFS) in patients with multiple myeloma relapsed after 1 to 3 prior therapies treated with carfilzomib or velcade.


Estimated Enrollment: 888
Study Start Date: June 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carfilzomib plus Dexamethasone (Cd)
Carfilzomib is administered over 30 minutes (± 5 minutes) as an infusion. For Cycle 1 only, carfilzomib is administered at 20 mg/m2 IV on Days 1 and 2, followed by escalation to 56 mg/m2 on Days 8, 9, 15, and 16. Patients who tolerate 56 mg/m2 in Cycle 1 are kept at this dose on Days 1, 2, 8, 9, 15, and 16 on a 28 day cycle. Dose and schedule modifications for intolerable side effects to carfilzomib are detailed in the protocol. Additionally, dexamethasone is administered on Days 1, 2, 8, 9, 15, 16, 22, and 23 of a 28 day cycle. On days when carfilzomib is administered, dexamethasone is to be given 30 minutes to 4 hours prior to carfilzomib.
Drug: Carfilzomib plus dexamethasone
Carfilzomib is administered over 30 minutes (± 5 minutes) as an infusion. For Cycle 1 only, carfilzomib is administered at 20 mg/m2 IV on Days 1 and 2, followed by escalation to 56 mg/m2 on Days 8, 9, 15, and 16. Patients who tolerate 56 mg/m2 in Cycle 1 are kept at this dose on Days 1, 2, 8, 9, 15, and 16 on a 28 day cycle. Dose and schedule modifications for intolerable side effects to carfilzomib are detailed in the protocol. Additionally, dexamethasone is administered on Days 1, 2, 8, 9, 15, 16, 22, and 23 of a 28 day cycle. On days when carfilzomib is administered, dexamethasone is to be given 30 minutes to 4 hours prior to carfilzomib.
Other Names:
  • PR-171
  • carfilzomib
  • Carfilzomib
Active Comparator: Bortezomib (Velcade®) and Dexamethasone (Vd)
Velcade 1.3 mg/m2 administered IV or subcutaneously (SC) (route of administration of Velcade in accordance with regulatory approval) administered on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of a 21-day cycle. Patients should be encouraged to continue to receive Velcade by the same route of administration (SC or IV) throughout treatment (i.e., a patient should not begin receiving IV and then switch to SC, or vice versa).
Drug: Velcade plus dexamethasone
Velcade 1.3 mg/m2 is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval) on Days 1, 4, 8, and 11 of each 21-day cycle until PD or intolerable side effects. Dose and schedule modifications for intolerable side effects to Velcade are detailed in the protocol. Additionally, dexamethasone 20 mg is given on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle. On days when Velcade is administered, the dexamethasone is to be given 30 minutes to 4 hours prior to Velcade.
Other Names:
  • Velcade
  • Bortezomib
  • bortezomib
  • Vd
  • vd

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Multiple myeloma with relapsing or progressing disease at study entry.
  2. Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization):

    • Serum M-protein ≥ 0.5 g/dL, or
    • Urine M-protein ≥ 200 mg/24 hour, or
    • In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or
    • For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL).
  3. Patients must have documented at least PR to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.
  4. Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
  5. Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).
  6. Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
  7. Males and females ≥ 18 years of age.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  9. Adequate hepatic function within 21 days prior to randomization, with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
  10. LVEF ≥ 40%.
  11. Absolute neutrophil count (ANC) ≥ 1000/mm3 within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.
  12. Hemoglobin ≥ 8.0 g/dL within 21 days prior to randomization. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.
  13. Platelet count ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
  14. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault:

    [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female.

  15. Written informed consent in accordance with federal, local, and institutional guidelines.
  16. Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to randomization and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  17. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.

Exclusion Criteria:

  1. Multiple Myeloma of IgM subtype.
  2. Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
  3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  4. Plasma cell leukemia or circulating plasma cells ≥ 2 × 109/L.
  5. Waldenstrom's Macroglobulinemia.
  6. Patients with known amyloidosis.
  7. Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
  8. Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
  9. Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
  10. Immunotherapy within 21 days prior to randomization.
  11. Major surgery (excluding kyphoplasty) within 28 days prior to randomization.
  12. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.
  13. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
  14. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
  15. Patients with known cirrhosis.
  16. Second malignancy within the past 3 years except:

    • adequately treated basal cell or squamous cell skin cancer
    • carcinoma in situ of the cervix
    • prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
    • breast carcinoma in situ with full surgical resection
    • treated medullary or papillary thyroid cancer
  17. Patients with myelodysplastic syndrome.
  18. Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
  19. Female patients who are pregnant or lactating.
  20. Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib).
  21. Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol.
  22. Patients with contraindication to dexamethasone.
  23. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
  24. Ongoing graft-vs-host disease.
  25. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568866

Contacts
Contact: Onyx Medical Information 877-ONYX-121 (877-669-9121) medinfo@onyx.com

  Hide Study Locations
Locations
United States, California
Providence St. Joseph Medical Center Active, not recruiting
Burbank, California, United States
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States
UCLA Medical Center Division of Hematology/Oncology Recruiting
Los Angeles, California, United States
Central Coast Medical Oncology Active, not recruiting
Santa Maria, California, United States
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States
United States, Florida
MAB Oncology/Hematology Active, not recruiting
Melbourne, Florida, United States
Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States
United States, Georgia
Winship Cancer Institute Emory University School of Medicine Recruiting
Atlanta, Georgia, United States
United States, Indiana
Hematology Oncology of Indiana, PC Active, not recruiting
Indianapolis, Indiana, United States
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States
Associates in Oncology/Hematology, PC Recruiting
Rockville, Maryland, United States
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States
United States, Missouri
University of Kansas Recruiting
Kansas City, Missouri, United States
United States, New Jersey
Hackensack University Medical Ctr Recruiting
Hackensack, New Jersey, United States
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States
Clinical Research Alliance Inc. Active, not recruiting
New York, New York, United States
Weill Cornell Medical College Recruiting
New York, New York, United States
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States
The Christ Hospital Recruiting
Cincinnati, Ohio, United States
United States, Pennsylvania
Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Oncology and Hematology Associates of SC, LLC dba Cancer Centers of the Carolinas Recruiting
Greenville, South Carolina, United States
United States, Tennessee
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States
United States, Texas
The Methodist Cancer Center Recruiting
Houston, Texas, United States
MD Anderson Recruiting
Houston, Texas, United States
Scott & White Healthcare Active, not recruiting
Temple, Texas, United States
United States, Utah
University of Utah School of Medicine Recruiting
Salt Lake City, Utah, United States
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia
St. Vincent's Hospital Recruiting
Darlinghurst, New South Wales, Australia
Saint George Hospital Recruiting
Kogarah, New South Wales, Australia
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia
Westmead Hospital Recruiting
Westmead, New South Wales, Australia
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia
Haematology & Oncology Clinics of Australia Recruiting
South Brisbane, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital Recruiting
Woodville, South Australia, Australia
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia
Monash Medical Centre Active, not recruiting
Clayton, Victoria, Australia
Saint Vincent's Hospital Recruiting
East Melbourne, Victoria, Australia
Western Hospital Recruiting
Footscray, Victoria, Australia
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia
Australia, Western Australia
Fremantle Hospital Recruiting
Fremantle, Western Australia, Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia
Austria
Medizinische Universität Innsbruck Recruiting
Innsbruck, Tyrol, Austria
Krankenhaus der Elisabethinen Linz, I Interne Abteilung Recruiting
Linz, Upper Austria, Austria
Wilhelminenspital der Stadt Wien Recruiting
Wien, Vienna, Austria
Belgium
Universitair Ziekenhuis Leuven Recruiting
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires UCL de Mont-Godinne Recruiting
Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent Recruiting
Ghent, Oost-vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen Recruiting
Antwerp, Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussels, Belgium
Cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium
Brazil
Liga Norte Riograndense Contra o Câncer Recruiting
Natal, Rio Grande Do Norte, Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital São Lucas da PUCRS Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Clínica de Oncologia de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Hemocentro Campinas-Unicamp Recruiting
Campinas, Sao Paulo, Brazil
Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro Recruiting
Rio de Janeiro, Brazil
Instituto Centros Oncológicos Integrados de Educação e Pesquisa Recruiting
Rio de Janeiro, Brazil
Instituto Nacional do Câncer-INCA Recruiting
Rio de Janeiro, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo Recruiting
São Paulo, Brazil
Bulgaria
Military Medical Academy Hospital for Active Treatment Active, not recruiting
Sofia, Sofiya, Bulgaria
Specialized Hospital for Active Treatment of Oncology Diseases, EAD Recruiting
Sofia, Sofiya, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD Recruiting
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment, "Sveta Marina'' Recruiting
Varna, Bulgaria
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
British Columbia Cancer Agency Recruiting
Kelowna, British Columbia, Canada
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre Recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada
Windsor Regional Hospital Recruiting
Windsor, Ontario, Canada
Canada, Quebec
Hopital Maisonneuve-Rosemont Recruiting
Montréal, Quebec, Canada
Czech Republic
Fakultní nemocnice Královské Vinohrady Recruiting
Praha 10, Praha, Czech Republic
Fakultní nemocnice Olomouc Recruiting
Olomouc, Severomoravsky Kraj, Czech Republic
FN Ostrava Recruiting
Ostrava, Severomoravsky Kraj, Czech Republic
Fakultní nemocnice Hradec Králové Recruiting
Hradec Kralové, Vychodocesky Kraj, Czech Republic
Fakultní nemocnice Brno Recruiting
Brno, Czech Republic
Všeobecná fakultní nemocnice v Praze Recruiting
Praha, Czech Republic
France
Centre Hospitalier de la Cote Basque Recruiting
Bayonne, Aquitaine, France
Centre Hospitalier Universitaire Brest Recruiting
Brest Cedex, Bretagne, France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou Recruiting
Rennes Cedex 9, Bretagne, France
Centre Henri-Becquerel Recruiting
Rouen Cedex 1, Haute-normandie, France
Centre Hospitalier de Versailles Recruiting
Le Chesnay, Ile-de-france, France
Hôpital Saint-Antoine Recruiting
Paris, Ile-de-france, France
Hôpital Saint Louis Recruiting
Paris, Ile-de-france, France
Hôpital Claude Huriez Recruiting
Lille Cedex, Nord Pas-de-calais, France
Hôpital Hôtel-Dieu Recruiting
Nantes cedex 1, Pays de La Loire, France
Institut Paoli Calmettes Recruiting
Marseille Cedex 9, Provence Alpes Cote D'azur, France
Centre Hospitalier Lyon Sud Recruiting
Pierre Bénite Cedex, Rhone-alpes, France
Germany
Universitätsklinik Heidelberg Recruiting
Heidelberg, Baden-wuerttemberg, Germany
Universitätsklinikum Tübingen Recruiting
Tübingen, Baden-wuerttemberg, Germany
Universitätsklinikum Ulm Recruiting
Ulm, Baden-wuerttemberg, Germany
Medizinische Klinik der Universität Würzburg Recruiting
Würzburg, Bayern, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany
Universitätsklinikum Aachen Recruiting
Aachen, Nordrhein-westfalen, Germany
Universitätsklinikum Münster Recruiting
Münster, Nordrhein-westfalen, Germany
Universitätsmedizin der Johannes Gutenberg Universität Recruiting
Mainz, Rheinland-pfalz, Germany
Universitätsklinikum des Saarlandes Recruiting
Homburg / Saar, Saarland, Germany
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Sachsen, Germany
Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I Recruiting
Dresden, Sachsen, Germany
Universitätsklinikum Leipzig Recruiting
Leipzig, Sachsen, Germany
Universitätsklinikum Jena Recruiting
Jena, Thuringen, Germany
Universitätsklinikum Hamburg Eppendorf Recruiting
Hamburg, Germany
Greece
Alexandra General Hospital Recruiting
Athens, Attica, Greece
Hungary
Bács Kiskun Megyei Kórháza, Szegedi Tudományegyetem Oktató Kórháza Active, not recruiting
Kecskemét, Bacs-kiskun, Hungary
Pécsi Tudományegyetem Recruiting
Pécs, Baranya, Hungary
Szegedi Tudományegyetem Recruiting
Szeged, Csongrad, Hungary
Debreceni Egyetem Orvos-és Egészségtudományi Centrum Recruiting
Debrecen, Hajdu-bihar, Hungary
Egyesített Szent István és Szent László Kórház-Rendelointézet Recruiting
Budapest, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház Recruiting
Kaposvár, Hungary
Israel
Rambam Health Corp. Recruiting
Haifa, Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
The Chaim Sheba Medical Center at Tel Hashomer Recruiting
Tel Hashomer, Israel
Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture Recruiting
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Recruiting
Orbassano, Torino, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Recruiting
Ancona, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Recruiting
Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino Recruiting
Genova, Italy
Azienda Ospedaliera Universitaria Maggiore della Carità Recruiting
Novara, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto Recruiting
Piacenza, Italy
Azienda Ospedaliera Pisana Ospedale Santa Chiara Recruiting
Pisa, Italy
Azienda Policlinico Umberto I di Roma Recruiting
Roma, Italy
Università Tor Vergata Ospedale Sant Eugenio Recruiting
Roma, Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte Recruiting
Siena, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, Italy
Japan
Nagoya City University Hospital Recruiting
Nagoya City, Aichi, Japan
Toyohashi Municipal Hospital Recruiting
Toyohashi, Aichi, Japan
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka-city, Fukuoka, Japan
Ogaki Municipal Hospital Recruiting
Ogaki City, Gifu, Japan
Gunma University Hospital Recruiting
Maebashi, Gunma, Japan
National Hospital Organization Nishigunma National Hospital Recruiting
Shibukawa, Gunma, Japan
Sapporo Medical University Hospital Recruiting
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital Recruiting
Kobe, Hyogo, Japan
Tokai University Hospital Recruiting
Isehara, Kanagawa, Japan
Niigata Cancer Center Hospital Recruiting
Niigata-city, Niigata, Japan
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of Japanese Foundation For Cancer Research Recruiting
Koto-ku, Tokyo, Japan
Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations Recruiting
Kyoto, Japan
National Hospital Organization Okayama Medical Center Recruiting
Okayama, Japan
Tokushima Prefectural Central Hospital Recruiting
Tokushima, Japan
Japanese Red Cross Medical Center Recruiting
Tokyo, Japan
Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Gyeonggi-Do, Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Gyeongsangnam-Do, Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Seoul Saint Mary's Hospital Recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
New Zealand
North Shore Hospital Recruiting
North Shore City, Auckland, New Zealand
Middlemore Hospital Recruiting
Otahuhu, Auckland, New Zealand
Auckland City Hospital Recruiting
Grafton, Aukland, New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand
Dunedin Hospital Recruiting
Dunedin, New Zealand
Poland
Specjalistyczny Szpital Miejski im. Mikolaja Kopernika Recruiting
Torun, Kujawsko-Pomorskie, Poland
Zamojski Szpital Niepubliczny Sp. z o.o. Recruiting
Zamosc, Lubelskie, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie Recruiting
Krakow, Malopolskie, Poland
Instytut Hematologii i Transfuzjologii Recruiting
Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Pomorskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich Recruiting
Chorzów, Slaskie, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu Recruiting
Poznan, Wielkopolskie, Poland
Romania
Spitalul Universitar de Urgenta Bucuresti (Vladareanu, Ana Maria) Active, not recruiting
Bucharest, Bucuresti, Romania
Spitalul Universitar de Urgenta Bucuresti Recruiting
Bucharest, Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia) Active, not recruiting
Brasov, Romania
Institutul Clinic Fundeni Recruiting
Bucuresti, Romania
Institutul Regional de Oncologie Iasi Recruiting
Iasi, Romania
Russian Federation
Republican Clinical Hospital #1 Recruiting
Izhevsk, Russian Federation
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway Recruiting
Moscow, Russian Federation
City Clinical Hospital n.a. S. P. Botkin Recruiting
Moscow, Russian Federation
Ryazan Regional Clinical Hospital Recruiting
Ryazan, Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology Recruiting
Saint Petersburg, Russian Federation
Saint Petersburg I.P. Pavlov State Medical University Recruiting
Saint Petersburg, Russian Federation
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies" Recruiting
Saint Petersburg, Russian Federation
Clinical Hospital Number 31 Recruiting
Saint Petersburg, Russian Federation
GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin Recruiting
Samara, Russian Federation
Singapore
National University Cancer Institute Recruiting
Singapore, Singapore
Singapore Oncology Consultants Recruiting
Singapore, Singapore
Singapore General Hospital Recruiting
Singapore, Singapore
Slovakia
Univerzitná nemocnica Bratislava Recruiting
Bratislava, Slovakia
Spain
Hospital Son Llàtzer Recruiting
Palma de Mallorca, Baleares, Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain
Hospital Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain
Institut Universitari Dexeus Recruiting
Barcelona, Spain
Hospital Universitario La Princesa Recruiting
Madrid, Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Hospital Clínico Universitario de Salamanca Recruiting
Salamanca, Spain
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain
Hospital Universitari i Politecnic La Fé de Valencia Recruiting
Valencia, Spain
Taiwan
Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-LinKou Branch Recruiting
Tao-Yuan, Taiwan
Thailand
Ramathibodi Hospital Recruiting
Bangkok, Bangkok Metropolis, Thailand
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Bangkok Metropolis, Thailand
Srinagarind Hospital Recruiting
Khon Kaen, Thailand
Ukraine
City Hematology Center Recruiting
Dnepropetrovsk, Dnipropretrovsk, Ukraine
Municipal Institution of Health Protection "Clinical Hospital #8" Recruiting
Kharkov, Kharkiv, Ukraine
Cherkassy Regional Oncology Center Recruiting
Cherkassy, Ukraine
Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences Recruiting
Donetsk, Ukraine
Khmelnytsky Regional Clinical Hospital Recruiting
Khmelnytsky, Ukraine
National Institute of Cancer, Oncohematology Department Recruiting
Kiev, Ukraine
Kyiv Bone Marrow Transplantation Center Recruiting
Kyiv, Ukraine
Lviv Regional Oncology Dispensary Recruiting
Lviv, Ukraine
Regional Clinical Hospital Recruiting
Mykolayiv, Ukraine
United Kingdom
Royal Free Hospital Recruiting
London, England, United Kingdom
University College Hospital Recruiting
London, England, United Kingdom
Manchester Royal Infirmary Recruiting
Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, England, United Kingdom
Churchill Hospital Recruiting
Oxford, England, United Kingdom
Derriford Hospital Recruiting
Plymouth, England, United Kingdom
Royal Hallamshire Hospital Recruiting
Sheffield, England, United Kingdom
Royal Marsden Hospital Recruiting
Surrey, England, United Kingdom
Royal Wolverhampton Hospitals Trust Recruiting
Wolverhampton, England, United Kingdom
Sponsors and Collaborators
Onyx Pharmaceuticals
Investigators
Principal Investigator: Hartmut Goldschmidt, MD Universitätsklinik Heidelberg, Heidelberg, Germany
Principal Investigator: Douglas Joshua, BSc, MBBS, DPhil (Oxon), FRACP Royal Prince Alfred Hospital, Camperdown, Australia
Principal Investigator: Philippe Moreau, MD Hôpital Hôtel-Dieu, NANTES Cedex 01, France
Principal Investigator: Robert Orlowski, PhD, MD UT M.D. Anderson Cancer Center, MD Anderson Cancer Center, Houston, Texas
  More Information

No publications provided

Responsible Party: Onyx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01568866     History of Changes
Other Study ID Numbers: 2011-003, 2012-000128-16
Study First Received: March 28, 2012
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Austria : Federal Ministry for Labour, Health, and Social Affairs
Austria: Ethikkommission
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ethics Committee
Brazil: Ministry of Health
Bulgaria: Ethics committee
Bulgaria: Ministry of Health
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ministry of Health
Germany: Ethics Commission
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Hungary: Institutional Ethics Committee
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ethics Commission
Italy: Ethics Committee
Italy: Ministry of Health
New Zealand: Ethics Committee
New Zealand: Medsafe
Poland: Ethics Committee
Poland: Ministry of Health
Romania: State Institute for Drug Control
Romania: Ethics Committee
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Singapore: Institutional Review Board
Slovakia: State Institute for Drug Control
Slovak Republic: Ethics Committee
Spain: Spanish Agency of Medicines
Spain: Ethics Committee
Taiwan: Department of Health
Taiwan: Research Ethics Committee
Ukraine: Ministry of Health
Ukraine: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Onyx Pharmaceuticals:
multiple myeloma
relapsed multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on April 15, 2014