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Trial record 1 of 1 for:    NCT01568866
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Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients (ENDEAVOR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01568866
First received: March 28, 2012
Last updated: December 14, 2015
Last verified: December 2015
  Purpose
The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

Condition Intervention Phase
Multiple Myeloma
Drug: Carfilzomib
Drug: Bortezomib
Drug: 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: From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively ] [ Designated as safety issue: No ]

    Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).

    Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.



Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until the data cut-off date of 10 November 2014; median follow-up time for OS was 11.9 and 12.5 months for each treatment group respectively. ] [ Designated as safety issue: No ]

    Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive).

    Median overall survival was estimated using the Kaplan-Meier method.


  • Overall Response [ Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. ] [ Designated as safety issue: No ]

    Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).

    sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).

    CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.

    PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.


  • Duration of Response [ Time Frame: From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively. ] [ Designated as safety issue: No ]
    Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.

  • Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy [ Time Frame: From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. ] [ Designated as safety issue: No ]

    Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.

    Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:

    Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.


  • Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

    A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.

    For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%.


  • Change From Baseline in Right Ventricular Fractional Area Change (FAC) [ Time Frame: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). ] [ Designated as safety issue: No ]
    Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.

  • Change From Baseline in Pulmonary Artery Systolic Pressure (PASP) [ Time Frame: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). ] [ Designated as safety issue: No ]
    Pulmonary artery pressure was measured using transthoracic echocardiogram.


Enrollment: 929
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carfilzomib plus Dexamethasone
Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
Drug: Carfilzomib
Carfilzomib is administered over 30 minutes as an infusion.
Other Names:
  • PR-171
  • Krypolis
Drug: Dexamethasone
Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.
Active Comparator: Bortezomib plus Dexamethasone
Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) 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 each 21-day cycle.
Drug: Bortezomib
Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)
Other Name: Velcade
Drug: Dexamethasone
Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 immunoglobulin (Ig) A 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 partial response (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. Left ventricular ejection fraction (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 × 10^9/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 human immunodeficiency (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568866

  Hide Study Locations
Locations
United States, California
Providence St. Joseph Medical Center
Burbank, California, United States
UCSD Moore Cancer Center
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Central Coast Medical Oncology Group
Santa Maria, California, United States
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States
United States, Florida
MAB Oncology/Hematology
Melbourne, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States
United States, Indiana
Hematology Oncology of Indiana, PC
Indianapolis, Indiana, United States
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Associates in Oncology/Hematology PC
Rockville, Maryland, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Missouri
University of Kansas
Kansas City, Missouri, United States
United States, New Jersey
Hackensack University Medical Ctr
Hackensack, New Jersey, United States
United States, New York
Montefiore Medical Center
Bronx, New York, United States
Clinical Research Alliance Inc.
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
United States, North Carolina
Wake Forest University Health Sciences, Section on Hematology and Oncology
Winston-Salem, North Carolina, United States
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
United States, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Hematology/Oncology Associates of SC
Greenville, South Carolina, United States
United States, Tennessee
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
United States, Texas
MD Anderson
Houston, Texas, United States
The Methodist Cancer Center
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St. Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia
Saint George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Haematology & Oncology Clinics of Australia
South Brisbane, Queensland, Australia
Haematology and Oncology Clinics of Australia at Chermside
South Brisbane, Queensland, Australia
Haematology and Oncology Clinics of Australia at Wesley
South Brisbane, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Saint Vincent's Hospital
East Melbourne, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sunshine Hospital
St. Albans, Victoria, Australia
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Austria
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz, Upper Austria, Austria
Wilhelminenspital der Stadt Wien
Wien, Vienna, Austria
Belgium
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande Do Norte, Brazil
Clínica de Oncologia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul, Brazil
Hemocentro Campinas-Unicamp
Campinas, Sao Paulo, Brazil
Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil
Instituto Centros Oncológicos Integrados de Educação e Pesquisa
Rio de Janeiro, Brazil
Instituto Nacional do Câncer-INCA
Rio de Janeiro, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Bulgaria
Military Medical Academy Hospital for Active Treatment
Sofia, Sofiya, Bulgaria
Shato, Ead
Sofia, Sofiya, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment, "Sveta Marina''
Varna, Bulgaria
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
British Columbia Cancer Agency
Kelowna, British Columbia, Canada
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montréal, Quebec, Canada
Czech Republic
Fakultní nemocnice Královské Vinohrady
Praha 10, Praha, Czech Republic
Fakultní nemocnice Olomouc
Olomouc, Severomoravsky Kraj, Czech Republic
FN Ostrava
Ostrava, Severomoravsky Kraj, Czech Republic
Fakultní nemocnice Hradec Králové
Hradec Kralové, Vychodocesky Kraj, Czech Republic
Fakultní nemocnice Brno
Brno, Czech Republic
Všeobecná fakultní nemocnice v Praze
Praha, Czech Republic
France
Centre Hospitalier de la Cote Basque
Bayonne, Aquitaine, France
Centre Hospitalier Universitaire Brest
Brest Cedex, Bretagne, France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes Cedex 9, Bretagne, France
Hopital Hotel-Dieu - Service d'Hematologie
Nantes, Cedex 1, France
Centre Henri-Becquerel
Rouen Cedex 1, Haute-normandie, France
Centre Hospitalier de Versailles
Le Chesnay, Ile-de-france, France
Hôpital Saint Louis
Paris, Ile-de-france, France
Hôpital Saint-Antoine
Paris, Ile-de-france, France
Hôpital Claude Huriez
Lille Cedex, Nord Pas-de-calais, France
Hôpital Hôtel-Dieu
Nantes cedex 1, Pays de La Loire, France
Institut Paoli Calmettes
Marseille Cedex 9, Provence Alpes Cote D'azur, France
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex, Rhone-alpes, France
Germany
Universitätsklinik Heidelberg
Heidelberg, Baden-wuerttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-wuerttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-wuerttemberg, Germany
Medizinische Klinik der Universität Würzburg
Würzburg, Bayern, Germany
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany
Universitätsklinikum Aachen
Aachen, Nordrhein-westfalen, Germany
Universitätsklinikum Münster
Münster, Nordrhein-westfalen, Germany
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, Rheinland-pfalz, Germany
Universitätsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Sachsen, Germany
Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I
Dresden, Sachsen, Germany
Universitätsklinikum Leipzig
Leipzig, Sachsen, Germany
Universitätsklinikum Jena
Jena, Thuringen, Germany
Universitatsklinikum Freiburg
Freiburg, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
Greece
Alexandra General Hospital
Athens, Attica, Greece
Hungary
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
Kecskemét, Bacs-kiskun, Hungary
Pécsi Tudományegyetem
Pécs, Baranya, Hungary
Szegedi Tudományegyetem
Szeged, Csongrad, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdu-bihar, Hungary
Egyesített Szent István és Szent László Kórház-Rendelointézet
Budapest, Hungary
Somogy Megyei Kaposi Mac okato Korhoz
Kaposvár, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary
Israel
Rambam Health Corp.
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
The Chaim Sheba Medical Center at Tel Hashomer
Tel Hashomer, Israel
Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
Orbassano, Torino, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, Italy
Azienda Ospedaliera Universitaria Maggiore della Carità
Novara, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, Italy
Azienda Ospedaliera Pisana Ospedale Santa Chiara
Pisa, Italy
Aienda Policknico Umberto I di Roma
Roma, Italy
Azienda Policknico Umberto l di Roma
Roma, Italy
Università Tor Vergata Ospedale Sant Eugenio
Roma, Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Siena, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy
Japan
Nagoya City University Hospital
Nagoya City, Aichi, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka-city, Fukuoka, Japan
Ogaki Municipal Hospital
Ogaki City, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
National Hospital Organization Nishigunma National Hospital
Shibukawa, Gunma, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Niigata Cancer Center Hospital
Niigata-city, Niigata, Japan
Osaka University Hospital
Suita, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of Japanese Foundation For Cancer Research
Koto-ku, Tokyo, Japan
Toranornon Hospital
Shinagawa, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku, Tokyo, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations
Kyoto, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Tokushima Prefectural Central Hospital
Tokushima, Japan
Japanese Red Cross Medical Center
Tokyo, Japan
Korea, Republic of
Gachon University Gil Medical Center
Incheon, Gyeonggi-Do, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital
Busan, Gyeongsangnam-Do, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul Saint Mary's Hospital
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
New Zealand
North Shore Hospital
North Shore City, Auckland, New Zealand
Middlemore Hospital
Otahuhu, Auckland, New Zealand
Auckland City Hospital
Grafton, Aukland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Poland
Specjalistyczny Szpital Miejski im. Mikolaja Kopernika
Torun, Kujawsko-Pomorskie, Poland
Zamojski Szpital Niepubliczny Sp. z o.o.
Zamosc, Lubelskie, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Malopolskie, Poland
Instytut Hematologii i Transfuzjologii
Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomorskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów, Slaskie, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
Poznan, Wielkopolskie, Poland
Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Bucuresti, Romania
Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie
Brasov, Romania
Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)
Brasov, Romania
Institutul Clinic Fundeni
Bucuresti, Romania
Institutul Regional de Oncologie Iasi
Iasi, Romania
Russian Federation
Republican Clinical Hospital #1
Izhevsk, Russian Federation
City Clinical Hospital n.a. S. P. Botkin
Moscow, Russian Federation
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
Moscow, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan, Russian Federation
Clinical Hospital Number 31
Saint Petersburg, Russian Federation
Federal Almazov Medical Research Centre
Saint Petersburg, Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, Russian Federation
First Saint Petersburg I.P. Pavlov State Medical University
Saint Petersburg, Russian Federation
GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin
Samara, Russian Federation
Singapore
National University Cancer Institute
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Singapore Oncology Consultants
Singapore, Singapore
Slovakia
Univerzitná nemocnica Bratislava
Bratislava, Slovakia
Spain
Hospital Son Llàtzer
Palma de Mallorca, Baleares, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain
Institut Universitari Dexeus
Barcelona, Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Hospital Universitari i Politecnic La Fé de Valencia
Valencia, Spain
Taiwan
Chang Gung Memorial Hospital
Kaohsiung, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-LinKou Branch
Tao-Yuan, Taiwan
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok Metropolis, Thailand
Ramathibodi Hospital
Bangkok, Bangkok Metropolis, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
Ukraine
City Hematology Center
Dnepropetrovsk, Dnipropretrovsk, Ukraine
Municipal Institution of Health Protection "Clinical Hospital #8"
Kharkov, Kharkiv, Ukraine
Cherkassy Regional Oncology Center
Cherkassy, Ukraine
MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center
Dnipropetrovsk, Ukraine
Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences
Donetsk, Ukraine
Khmelnytsky Regional Clinical Hospital
Khmelnytsky, Ukraine
Khmelnytsky Regional Hospital, Department of Hematology
Khmelnytsky, Ukraine
National Institute of Cancer, Oncohematology Department
Kiev, Ukraine
Kyiv Bone Marrow Transplantation Center
Kyiv, Ukraine
Lviv Regional Oncology Dispensary
Lviv, Ukraine
Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy
Lviv, Ukraine
Regional Clinical Hospital
Mykolayiv, Ukraine
United Kingdom
Royal Free Hospital
London, England, United Kingdom
University College Hospital
London, England, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Royal Marsden Hospital
Surrey, England, United Kingdom
Royal Wolverhampton Hospitals Trust
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: November 6, 2015
Last Updated: December 14, 2015
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
Japan: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare
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
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Spain: Ethics Committee
Taiwan: Department of Health
Taiwan: Research Ethics Committee
Thailand: Food and Drug Administration
Thailand: Institutional Review Board
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 28, 2016