Phase 3 Study With Carfilzomib and Dexamethasone Versus Velcade and Dexamethasone for Relapsed Multiple Myeloma Patients
This trial is active, not recruiting.
|Treatments||carfilzomib plus dexamethasone, velcade plus dexamethasone|
|Start date||June 2012|
|End date||January 2016|
|Trial size||898 participants|
|Trial identifier||NCT01568866, 2011-003, 2012-000128-16|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Burbank, CA||Providence St. Joseph Medical Center||no longer recruiting|
|La Jolla, CA||UCSD Moore Cancer Center||no longer recruiting|
|Los Angeles, CA||UCLA Medical Center||no longer recruiting|
|Santa Maria, CA||Central Coast Medical Oncology Group||no longer recruiting|
|Denver, CO||Colorado Blood Cancer Institute||no longer recruiting|
|Melbourne, FL||MAB Oncology/Hematology||no longer recruiting|
|West Palm Beach, FL||Palm Beach Cancer Institute||no longer recruiting|
|Atlanta, GA||Winship Cancer Institute||no longer recruiting|
|Indianapolis, IN||Hematology Oncology of Indiana, PC||no longer recruiting|
|Bethesda, MD||Center for Cancer and Blood Disorders||no longer recruiting|
|Rockville, MD||Associates in Oncology/Hematology PC||no longer recruiting|
|Ann Arbor, MI||University of Michigan||no longer recruiting|
|Kansas City, MO||University of Kansas||no longer recruiting|
|Hackensack, NJ||Hackensack University Medical Ctr||no longer recruiting|
|Bronx, NY||Montefiore Medical Center||no longer recruiting|
|New York, NY||Clinical Research Alliance Inc.||no longer recruiting|
|New York, NY||Weill Cornell Medical College||no longer recruiting|
|Winston-Salem, NC||Wake Forest University Health Sciences, Section on Hematology and Oncology||no longer recruiting|
|Canton, OH||Gabrail Cancer Center||no longer recruiting|
|Cincinnati, OH||The Christ Hospital||no longer recruiting|
|Pittsburgh, PA||Western Pennsylvania Hospital||no longer recruiting|
|Greenville, SC||Hematology/Oncology Associates of SC||no longer recruiting|
|Nashville, TN||Vanderbilt Ingram Cancer Center||no longer recruiting|
|Houston, TX||MD Anderson||no longer recruiting|
|Houston, TX||The Methodist Cancer Center||no longer recruiting|
|Temple, TX||Scott & White Memorial Hospital||no longer recruiting|
|Salt Lake City, UT||University of Utah School of Medicine||no longer recruiting|
|Camperdown, Australia||Royal Prince Alfred Hospital||no longer recruiting|
|Darlinghurst, Australia||St. Vincent's Public Hospital Sydney||no longer recruiting|
|Kogarah, Australia||Saint George Hospital||no longer recruiting|
|Liverpool, Australia||Liverpool Hospital||no longer recruiting|
|Saint Leonards, Australia||Royal North Shore Hospital||no longer recruiting|
|Waratah, Australia||Calvary Mater Newcastle||no longer recruiting|
|Westmead, Australia||Westmead Hospital||no longer recruiting|
|Herston, Australia||Royal Brisbane and Women's Hospital||no longer recruiting|
|South Brisbane, Australia||Haematology & Oncology Clinics of Australia||no longer recruiting|
|South Brisbane, Australia||Haematology and Oncology Clinics of Australia at Chermside||no longer recruiting|
|South Brisbane, Australia||Haematology and Oncology Clinics of Australia at Wesley||no longer recruiting|
|Adelaide, Australia||Royal Adelaide Hospital||no longer recruiting|
|Woodville, Australia||The Queen Elizabeth Hospital||no longer recruiting|
|Box Hill, Australia||Box Hill Hospital||no longer recruiting|
|Clayton, Australia||Monash Medical Centre||no longer recruiting|
|East Melbourne, Australia||Saint Vincent's Hospital||no longer recruiting|
|Footscray, Australia||Western Hospital||no longer recruiting|
|Melbourne, Australia||The Alfred Hospital||no longer recruiting|
|St. Albans, Australia||Sunshine Hospital||no longer recruiting|
|Fremantle, Australia||Fremantle Hospital||no longer recruiting|
|Perth, Australia||Royal Perth Hospital||no longer recruiting|
|Innsbruck, Austria||Medizinische Universität Innsbruck||no longer recruiting|
|Linz, Austria||Krankenhaus der Elisabethinen Linz, I Interne Abteilung||no longer recruiting|
|Wien, Austria||Wilhelminenspital der Stadt Wien||no longer recruiting|
|Leuven, Belgium||Universitair Ziekenhuis Leuven||no longer recruiting|
|Yvoir, Belgium||Cliniques Universitaires UCL de Mont-Godinne||no longer recruiting|
|Ghent, Belgium||Universitair Ziekenhuis Gent||no longer recruiting|
|Antwerp, Belgium||Ziekenhuis Netwerk Antwerpen||no longer recruiting|
|Brussels, Belgium||Cliniques Universitaires Saint Luc||no longer recruiting|
|Brussels, Belgium||Universitair Ziekenhuis Brussel||no longer recruiting|
|Natal, Brazil||Liga Norte Riograndense Contra o Câncer||no longer recruiting|
|Porto Alegre, Brazil||Clínica de Oncologia de Porto Alegre||no longer recruiting|
|Porto Alegre, Brazil||Hospital de Clínicas de Porto Alegre||no longer recruiting|
|Porto Alegre, Brazil||Hospital São Lucas da PUCRS||no longer recruiting|
|Campinas, Brazil||Hemocentro Campinas-Unicamp||no longer recruiting|
|Rio de Janeiro, Brazil||Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro||no longer recruiting|
|Rio de Janeiro, Brazil||Instituto Centros Oncológicos Integrados de Educação e Pesquisa||no longer recruiting|
|Rio de Janeiro, Brazil||Instituto Nacional do Câncer-INCA||no longer recruiting|
|São Paulo, Brazil||Irmandade da Santa Casa de Misericórdia de São Paulo||no longer recruiting|
|Sofia, Bulgaria||Military Medical Academy Hospital for Active Treatment||no longer recruiting|
|Sofia, Bulgaria||Shato, Ead||no longer recruiting|
|Plovdiv, Bulgaria||University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD||no longer recruiting|
|Varna, Bulgaria||Multiprofile Hospital for Active Treatment, "Sveta Marina''||no longer recruiting|
|Edmonton, Canada||University of Alberta Hospital||no longer recruiting|
|Kelowna, Canada||British Columbia Cancer Agency||no longer recruiting|
|Saint John, Canada||Saint John Regional Hospital||no longer recruiting|
|Halifax, Canada||Queen Elizabeth II Health Science Centre||no longer recruiting|
|London, Canada||London Health Sciences Centre||no longer recruiting|
|Ottawa, Canada||The Ottawa Hospital Regional Cancer Centre||no longer recruiting|
|Windsor, Canada||Windsor Regional Hospital||no longer recruiting|
|Montréal, Canada||Hopital Maisonneuve-Rosemont||no longer recruiting|
|Praha 10, Czech Republic||Fakultní nemocnice Královské Vinohrady||no longer recruiting|
|Olomouc, Czech Republic||Fakultní nemocnice Olomouc||no longer recruiting|
|Ostrava, Czech Republic||FN Ostrava||no longer recruiting|
|Hradec Kralové, Czech Republic||Fakultní nemocnice Hradec Králové||no longer recruiting|
|Brno, Czech Republic||Fakultní nemocnice Brno||no longer recruiting|
|Praha, Czech Republic||Všeobecná fakultní nemocnice v Praze||no longer recruiting|
|Bayonne, France||Centre Hospitalier de la Cote Basque||no longer recruiting|
|Brest Cedex, France||Centre Hospitalier Universitaire Brest||no longer recruiting|
|Rennes Cedex 9, France||Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou||no longer recruiting|
|Nantes, France||Hopital Hotel-Dieu - Service d'Hematologie||no longer recruiting|
|Rouen Cedex 1, France||Centre Henri-Becquerel||no longer recruiting|
|Le Chesnay, France||Centre Hospitalier de Versailles||no longer recruiting|
|Paris, France||Hôpital Saint Louis||no longer recruiting|
|Paris, France||Hôpital Saint-Antoine||no longer recruiting|
|Lille Cedex, France||Hôpital Claude Huriez||no longer recruiting|
|Nantes cedex 1, France||Hôpital Hôtel-Dieu||no longer recruiting|
|Marseille Cedex 9, France||Institut Paoli Calmettes||no longer recruiting|
|Pierre Bénite Cedex, France||Centre Hospitalier Lyon Sud||no longer recruiting|
|Heidelberg, Germany||Universitätsklinik Heidelberg||no longer recruiting|
|Tübingen, Germany||Universitätsklinikum Tübingen||no longer recruiting|
|Ulm, Germany||Universitätsklinikum Ulm||no longer recruiting|
|Würzburg, Germany||Medizinische Klinik der Universität Würzburg||no longer recruiting|
|Hannover, Germany||Medizinische Hochschule Hannover||no longer recruiting|
|Aachen, Germany||Universitätsklinikum Aachen||no longer recruiting|
|Münster, Germany||Universitätsklinikum Münster||no longer recruiting|
|Mainz, Germany||Universitätsmedizin der Johannes Gutenberg Universität||no longer recruiting|
|Homburg / Saar, Germany||Universitätsklinikum des Saarlandes||no longer recruiting|
|Chemnitz, Germany||Klinikum Chemnitz gGmbH||no longer recruiting|
|Dresden, Germany||Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I||no longer recruiting|
|Leipzig, Germany||Universitätsklinikum Leipzig||no longer recruiting|
|Jena, Germany||Universitätsklinikum Jena||no longer recruiting|
|Freiburg, Germany||Universitatsklinikum Freiburg||no longer recruiting|
|Hamburg, Germany||Universitätsklinikum Hamburg Eppendorf||no longer recruiting|
|Athens, Greece||Alexandra General Hospital||no longer recruiting|
|Kecskemét, Hungary||Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza||no longer recruiting|
|Pécs, Hungary||Pécsi Tudományegyetem||no longer recruiting|
|Szeged, Hungary||Szegedi Tudományegyetem||no longer recruiting|
|Debrecen, Hungary||Debreceni Egyetem Klinikai Központ||no longer recruiting|
|Budapest, Hungary||Egyesített Szent István és Szent László Kórház-Rendelointézet||no longer recruiting|
|Kaposvár, Hungary||Somogy Megyei Kaposi Mac okato Korhoz||no longer recruiting|
|Kaposvár, Hungary||Somogy Megyei Kaposi Mór Oktató Kórház||no longer recruiting|
|Haifa, Israel||Rambam Health Corp.||no longer recruiting|
|Jerusalem, Israel||Hadassah Medical Center||no longer recruiting|
|Kfar Saba, Israel||Meir Medical Center||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Center||no longer recruiting|
|Tel Hashomer, Israel||The Chaim Sheba Medical Center at Tel Hashomer||no longer recruiting|
|Rionero in Vulture, Italy||IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture||no longer recruiting|
|Orbassano, Italy||Azienda Ospedaliero-Univesitaria San Luigi Gonzaga||no longer recruiting|
|Ancona, Italy||Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona||no longer recruiting|
|Bologna, Italy||Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi||no longer recruiting|
|Brescia, Italy||Azienda Ospedaliera Spedali Civili di Brescia||no longer recruiting|
|Genova, Italy||IRCCS Azienda Ospedaliera Universitaria San Martino||no longer recruiting|
|Novara, Italy||Azienda Ospedaliera Universitaria Maggiore della Carità||no longer recruiting|
|Piacenza, Italy||Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto||no longer recruiting|
|Pisa, Italy||Azienda Ospedaliera Pisana Ospedale Santa Chiara||no longer recruiting|
|Roma, Italy||Aienda Policknico Umberto I di Roma||no longer recruiting|
|Roma, Italy||Azienda Policknico Umberto l di Roma||no longer recruiting|
|Roma, Italy||Università Tor Vergata Ospedale Sant Eugenio||no longer recruiting|
|Siena, Italy||Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte||no longer recruiting|
|Torino, Italy||Azienda Ospedaliera Città della Salute e della Scienza di Torino||no longer recruiting|
|Nagoya City, Japan||Nagoya City University Hospital||no longer recruiting|
|Toyohashi, Japan||Toyohashi Municipal Hospital||no longer recruiting|
|Fukuoka-city, Japan||National Hospital Organization Kyushu Cancer Center||no longer recruiting|
|Ogaki City, Japan||Ogaki Municipal Hospital||no longer recruiting|
|Maebashi, Japan||Gunma University Hospital||no longer recruiting|
|Shibukawa, Japan||National Hospital Organization Nishigunma National Hospital||no longer recruiting|
|Sapporo, Japan||Sapporo Medical University Hospital||no longer recruiting|
|Kobe, Japan||Kobe City Medical Center General Hospital||no longer recruiting|
|Isehara, Japan||Tokai University Hospital||no longer recruiting|
|Niigata-city, Japan||Niigata Cancer Center Hospital||no longer recruiting|
|Suita, Japan||Osaka University Hospital||no longer recruiting|
|Kawagoe, Japan||Saitama Medical Center||no longer recruiting|
|Utsunomiya, Japan||Tochigi Cancer Center||no longer recruiting|
|Chuo-ku, Japan||National Cancer Center Hospital||no longer recruiting|
|Koto-ku, Japan||The Cancer Institute Hospital Of Japanese Foundation For Cancer Research||no longer recruiting|
|Shinagawa, Japan||Toranornon Hospital||no longer recruiting|
|Shinjuku, Japan||Tokyo Medical University Hospital||no longer recruiting|
|Tachikawa, Japan||National Hospital Organization Disaster Medical Center||no longer recruiting|
|Fukuoka, Japan||Kyushu University Hospital||no longer recruiting|
|Kyoto, Japan||Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations||no longer recruiting|
|Kyoto, Japan||University Hospital, Kyoto Prefectural University of Medicine||no longer recruiting|
|Okayama, Japan||National Hospital Organization Okayama Medical Center||no longer recruiting|
|Tokushima, Japan||Tokushima Prefectural Central Hospital||no longer recruiting|
|Tokyo, Japan||Japanese Red Cross Medical Center||no longer recruiting|
|Incheon, Korea, Republic of||Gachon University Gil Medical Center||no longer recruiting|
|Seongnam-si, Korea, Republic of||Seoul National University Bundang Hospital||no longer recruiting|
|Busan, Korea, Republic of||Pusan National University Hospital||no longer recruiting|
|Daegu, Korea, Republic of||Kyungpook National University Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Asan Medical Center||no longer recruiting|
|Seoul, Korea, Republic of||Samsung Medical Center||no longer recruiting|
|Seoul, Korea, Republic of||Seoul National University Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Seoul Saint Mary's Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Severance Hospital, Yonsei University Health System||no longer recruiting|
|North Shore City, New Zealand||North Shore Hospital||no longer recruiting|
|Otahuhu, New Zealand||Middlemore Hospital||no longer recruiting|
|Grafton, New Zealand||Auckland City Hospital||no longer recruiting|
|Christchurch, New Zealand||Christchurch Hospital||no longer recruiting|
|Dunedin, New Zealand||Dunedin Hospital||no longer recruiting|
|Torun, Poland||Specjalistyczny Szpital Miejski im. Mikolaja Kopernika||no longer recruiting|
|Zamosc, Poland||Zamojski Szpital Niepubliczny Sp. z o.o.||no longer recruiting|
|Krakow, Poland||Szpital Uniwersytecki w Krakowie||no longer recruiting|
|Warszawa, Poland||Instytut Hematologii i Transfuzjologii||no longer recruiting|
|Gdansk, Poland||Uniwersyteckie Centrum Kliniczne||no longer recruiting|
|Chorzów, Poland||Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich||no longer recruiting|
|Poznan, Poland||Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu||no longer recruiting|
|Bucharest, Romania||Spitalul Universitar de Urgenta Bucuresti||no longer recruiting|
|Brasov, Romania||Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie||no longer recruiting|
|Brasov, Romania||Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)||no longer recruiting|
|Bucuresti, Romania||Institutul Clinic Fundeni||no longer recruiting|
|Iasi, Romania||Institutul Regional de Oncologie Iasi||no longer recruiting|
|Izhevsk, Russian Federation||Republican Clinical Hospital #1||no longer recruiting|
|Moscow, Russian Federation||City Clinical Hospital n.a. S. P. Botkin||no longer recruiting|
|Moscow, Russian Federation||Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway||no longer recruiting|
|Ryazan, Russian Federation||Ryazan Regional Clinical Hospital||no longer recruiting|
|Saint Petersburg, Russian Federation||Clinical Hospital Number 31||no longer recruiting|
|Saint Petersburg, Russian Federation||Federal Almazov Medical Research Centre||no longer recruiting|
|Saint Petersburg, Russian Federation||FGU Russian Scientific Research Institute of Hematology and Transfusiology||no longer recruiting|
|Saint Petersburg, Russian Federation||First Saint Petersburg I.P. Pavlov State Medical University||no longer recruiting|
|Samara, Russian Federation||GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin||no longer recruiting|
|Singapore, Singapore||National University Cancer Institute||no longer recruiting|
|Singapore, Singapore||Singapore General Hospital||no longer recruiting|
|Singapore, Singapore||Singapore Oncology Consultants||no longer recruiting|
|Bratislava, Slovakia||Univerzitná nemocnica Bratislava||no longer recruiting|
|Palma de Mallorca, Spain||Hospital Son Llàtzer||no longer recruiting|
|Badalona, Spain||Hospital Universitari Germans Trias i Pujol||no longer recruiting|
|Barcelona, Spain||Hospital Clinic I Provincial de Barcelona||no longer recruiting|
|Barcelona, Spain||Institut Universitari Dexeus||no longer recruiting|
|Madrid, Spain||Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro||no longer recruiting|
|Madrid, Spain||Hospital Universitario 12 de Octubre||no longer recruiting|
|Madrid, Spain||Hospital Universitario La Princesa||no longer recruiting|
|Salamanca, Spain||Hospital Clínico Universitario de Salamanca||no longer recruiting|
|Sevilla, Spain||Hospital Universitario Virgen del Rocio||no longer recruiting|
|Valencia, Spain||Hospital Universitari i Politecnic La Fé de Valencia||no longer recruiting|
|Kaohsiung, Taiwan||Chang Gung Memorial Hospital||no longer recruiting|
|Taichung, Taiwan||China Medical University Hospital||no longer recruiting|
|Tainan, Taiwan||National Cheng-Kung University Hospital||no longer recruiting|
|Taipei, Taiwan||National Taiwan University Hospital||no longer recruiting|
|Taipei, Taiwan||Taipei Veterans General Hospital||no longer recruiting|
|Tao-Yuan, Taiwan||Chang Gung Medical Foundation-LinKou Branch||no longer recruiting|
|Bangkok, Thailand||King Chulalongkorn Memorial Hospital||no longer recruiting|
|Bangkok, Thailand||Ramathibodi Hospital||no longer recruiting|
|Khon Kaen, Thailand||Srinagarind Hospital||no longer recruiting|
|Dnepropetrovsk, Ukraine||City Hematology Center||no longer recruiting|
|Kharkov, Ukraine||Municipal Institution of Health Protection "Clinical Hospital #8"||no longer recruiting|
|Cherkassy, Ukraine||Cherkassy Regional Oncology Center||no longer recruiting|
|Dnipropetrovsk, Ukraine||MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center||no longer recruiting|
|Donetsk, Ukraine||Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences||no longer recruiting|
|Khmelnytsky, Ukraine||Khmelnytsky Regional Clinical Hospital||no longer recruiting|
|Khmelnytsky, Ukraine||Khmelnytsky Regional Hospital, Department of Hematology||no longer recruiting|
|Kiev, Ukraine||National Institute of Cancer, Oncohematology Department||no longer recruiting|
|Kyiv, Ukraine||Kyiv Bone Marrow Transplantation Center||no longer recruiting|
|Lviv, Ukraine||Lviv Regional Oncology Dispensary||no longer recruiting|
|Lviv, Ukraine||Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy||no longer recruiting|
|Mykolayiv, Ukraine||Regional Clinical Hospital||no longer recruiting|
|London, United Kingdom||Royal Free Hospital||no longer recruiting|
|London, United Kingdom||University College Hospital||no longer recruiting|
|Manchester, United Kingdom||Manchester Royal Infirmary||no longer recruiting|
|Nottingham, United Kingdom||Nottingham University Hospitals NHS Trust||no longer recruiting|
|Oxford, United Kingdom||Churchill Hospital||no longer recruiting|
|Plymouth, United Kingdom||Derriford Hospital||no longer recruiting|
|Sheffield, United Kingdom||Royal Hallamshire Hospital||no longer recruiting|
|Surrey, United Kingdom||Royal Marsden Hospital||no longer recruiting|
|Wolverhampton, United Kingdom||Royal Wolverhampton Hospitals Trust||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Progression Free Survival
time frame: 30 months
Male or female participants at least 18 years old.
- Multiple myeloma with relapsing or progressing disease at study entry.
- 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).
- Patients must have documented at least PR to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.
- 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).
- 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).
- 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.
- Males and females ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- 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.
- LVEF ≥ 40%.
- Absolute neutrophil count (ANC) ≥ 1000/mm3 within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.
- 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.
- 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.
- 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.
- Written informed consent in accordance with federal, local, and institutional guidelines.
- 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).
- 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.
- Multiple Myeloma of IgM subtype.
- Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Plasma cell leukemia or circulating plasma cells ≥ 2 × 109/L.
- Waldenstrom's Macroglobulinemia.
- Patients with known amyloidosis.
- Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
- Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
- 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).
- Immunotherapy within 21 days prior to randomization.
- Major surgery (excluding kyphoplasty) within 28 days prior to randomization.
- 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.
- Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
- 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).
- Patients with known cirrhosis.
- 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
- Patients with myelodysplastic syndrome.
- Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
- Female patients who are pregnant or lactating.
- Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib).
- Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol.
- Patients with contraindication to dexamethasone.
- 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.
- Ongoing graft-vs-host disease.
- Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.
|Official title||A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma|
|Principal investigator||Hartmut Goldschmidt, MD|
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