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PX-171-011 – A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma (FOCUS)
Eligibility criteria and sites that are open and accruing patients.
03.03.11
Eligibility


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

Criteria

Inclusion Criteria:

  1. Multiple myeloma
  2. Measurable disease, as defined by one or both of the following (assessed within 14 days prior to randomization):
    • Serum M-protein > 0.5 g/dL
    • Urine Bence-Jones protein > 200 mg/24 hours
  3. Responsive (defined as a 25% or greater decrease in M-protein or total protein) to at least one line of prior therapy
  4. Refractory to most recent therapy (defined as disease progression during treatment or within 60 days after discontinuation of treatment)
  5. Received 3 or more prior therapeutic regimens for multiple myeloma
  6. Adequate prior treatment with bortezomib (if less than 4 cycles, the reason for discontinuation must be reviewed by the Medical Monitor)
  7. Prior treatment with an immunomodulatory agent (lenalidomide if available, and/or thalidomide)
  8. Prior treatment with an alkylating agent (standard or high-dose)
  9. Prior treatment with a corticosteroid
  10. Prior treatment with an anthracycline unless not clinically indicated (eg, cardiac disease)
  11. Age > 18 years
  12. Life expectancy of at least 1 month
  13. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  14. Adequate hepatic function, with serum ALT < 4 times the upper limit of normal and serum direct bilirubin < 2.5 mg/dL (42.5 µmol/L)
  15. Total white blood cell (WBC) count > 1.5 x 109/L and absolute neutrophil count (ANC) > 1.0 x 109/L (use of colony-stimulating factors to achieve these counts is allowed)
  16. Hemoglobin > 7.5 g/dL (75 g/L) (use of erythropoietic stimulating factors is allowed)
  17. Platelet count > 30 x 109/L
  18. Creatinine clearance (CrCl) > 15 mL/minute (either measured or calculated using a standard formula such as Cockcroft and Gault) and dialysis-independent
  19. Written informed consent in accordance with regulatory guidelines
  20. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days of the first dose and agree to use an effective method of contraception during the study and for 3 months following the last dose of study drug. Post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.

Exclusion Criteria:

  1. Waldenström's macroglobulinemia or IgM myeloma
  2. Refractory to all prior therapies
  3. Disease measurable only by serum free light chain assay (SFLC)
  4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  5. Plasma cell leukemia (> 2.0 x 109/L circulating plasma cells by standard differential)
  6. Prior carfilzomib treatment
  7. Chemotherapy (approved or investigational) within 2 weeks prior to randomization
  8. Immunotherapy or antibody therapy within 4 weeks prior to randomization
  9. High-dose corticosteroids (eg, dexamethasone > 20 mg/day or prednisolone > 100 mg/day) at any time within 2 weeks prior to randomization
  10. Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
  11. Radiotherapy within 7 days prior to randomization
  12. Major surgery within 21 days prior to randomization
  13. Congestive heart failure (NYHA Class III or IV) or symptomatic cardiac ischemia, conduction system abnormalities uncontrolled by conventional intervention (conduction abnormalities not clinically warranting intervention are allowed)
  14. Myocardial infarction in the previous 3 months
  15. Acute active infection requiring systemic treatment (antibiotics, antivirals, or antifungals) within 14 days prior to randomization
  16. Known human immunodeficiency virus seropositivity
  17. Active hepatitis A, B, or C infection
  18. Other malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix, vulva, or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, carcinoma in situ of the breast, or benign tumors of the adrenal or pancreas
  19. Significant neuropathy (Grades 3-4, or Grade 2 with pain) at the time of randomization
  20. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
  21. Pregnant or lactating females

Here are the sites open and accruing thus far:

  • Austria

    Center for Oncology and Haematology
    Vienna, Austria, 1160
    Contact: Heinz Ludwig, MD +43 1 49150 2101

    University Clinic for Internal Medicin III Salzburg with Haematology & Medical Oncology
    Salzburg, Austria, 5020
    Contact: Gudrun Russ, MD + 43 662 4482 2879

    General public hospital of the Elisabethinen Linz
    Linz, Austria, 4010
    Contact: Michaela Binder, MD + 43 732 7676 3350

    Wilhelminen Hospital of the city Vienna
    Vienna, Austria, 1160
    Contact: Eva-Maria Autzinger, MD +43 1 49150 2101

    University Hospital for internal medicine
    Vienna, Austria 1090
    Contact: Dr. Drach 43 1 40400 4466

  • Czech Republic

    University Hospital - Department of Internal Medicine
    Contact: Roman Hajek, MD +420 532 232 144

    University Hospital Kralovske Vinohrady
    Prague, Czech Republic , 100 34
    Contact: Dr. Petr Pavlíček +420 732 524 684

    University Hospital Hradec Kralove
    Hradec Kralove, Czech Republic, 500 05
    Contact: Dr. Jakub Radocha +420 495 833 686

    University Hospital Olomouc
    Olomouc, Czech Republic , 775 20
    Contact: Dr. Jaroslav Bačovský +420 588 443 551

    General University Hospital Prague
    Prague, Czech Republic, 128 08
    Contact: Dr. Jan Straub +420 224 962 551

  • Hungary

    St. Istvan and St. Laszlo Hospital of Budapest
    Budapest, Hungary, 1097
    Contact: Sandor Fekete 1-455-8253

    University of Debrecen, Medical and Health Science Center
    Debrecen, Hungary, 4032
    Contact: Dr. Illés 52/255-218

    Bekes County Pandy Kalman Hospital
    Gyula, Hungary, 5700
    Contact: Dr. Jakucs 36 66-526-526

    University of Pecs
    Pécs, Hungary, 7624
    Contact: Dr. Dávid 36 72-536-00/6160, 6163

    Kaposi Mor County Teaching Hospital
    Kaposvár, Hungary, 7400
    Contact: Dr. Egyed 36 82-501-300

    St. Istvan and St. Laszlo Hospital of Budapest
    Budapest, Hungary, 1097
    Contact: Dr. Masszi 1-350-2019

    University of Szeged
    Szeged, Hungary, 6720
    Contact: Dr. Borbényi , 62-545-235

    Petz Aladar County Teaching Hospital
    Győr, Hungary, 9023
    Contact: Dr. Gasztonyi , 36 96-418-244

  • Italy

    Azienda Policlinico Umberto I
    Roma, Italy 00161
    Contact: Roberto Foà, 39 06 85795430

    Ospedale Molinette Divisione Universitaria di Ematologia
    Torino, Italy, 10126
    Contact: Antonio Palumbo, MD, PhD, 39 011 6336107

  • Poland

    Stanisław Staszic Specialist Hospital in Pila
    Pila, Poland
    Contact: Dr. Wiszniewski 48 67 21 06 420

    ‘Zamojski Non-Public Hospital’ Limited liability company
    Zamosc, Poland
    Contact: Dr. Gornik 48 84 677 50 87

    Maria Skłodowska-Curie Institute of Oncology
    Warsaw, Poland
    Contact: Dr. Walewski 48 22 546 22 23

    Lord's Transfiguration Teaching Hospital of Poznan University of Medical Sciences
    Poznań, Poland
    Contact: Dr. Komarnicki 48 61 854 93 83

    Nicolaus Copernicus Municipal Specialist Hospital
    Torun, Poland
    Contact: Dr. Calbecka 48 56 610 02 49

    University Teaching Hospital in Białystok
    Bialystok, Poland
    Contact: Dr. Kloczko 48 85 746 86 03

    Institute of Hematology and Transfusiology
    Warsaw, Poland
    Contact: Dr. Warzocha 48 22 349 61 76

    Maria Sklodowska-Curie Institute of Oncology
    Warsaw, Poland
    Contact: Dr. Walewski 48 22 546 22 23

  • Russia

    Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care
    St. Petersburg, Russia , 191024
    Contact: Dr. Abdulkadyrov 7 812 717 5857

    St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development
    St. Petersburg, Russia, 197101
    Contact: Afanasyev 7 812 234 46 25

    Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High-Tech Medical Care
    St. Petersburg, Russia , 194156
    Contact: Dr. Alexeeva 7 812 702 37 65 1205

    Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center
    Moscow, Russia, 115478
    Contact: Osmanov (495) 324 2804

    St. Peterburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development
    St. Petersburg, Russia, 197022
    Contact: Dr. Salogub 7 812 499 71 86

  • Spain

    Hospital Clinic Barcelona
    Barcelona, Spain, 08036
    Contact: Dr. Rosinol 932275511

    Hospital Universitario, Salamanca
    Salamanca, Spain, 37007
    Contact: Dr. San Miguel 923 291 384

    Hospital Universitari Germans Trias i Pujol
    Badalona (Barcelona), Spain, 08915
    Contact: Dr. Oriol 0034 934516631

    Hospital Universitario Virgen del Rocío
    Sevilla, Spain 41013
    Contact: Dr. Pérez-Simón 0034955013261



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