Multiple Myeloma Clinical Trial
Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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 immunoglobulin (Ig) A 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 partial response (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.
Left ventricular ejection fraction (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.
Exclusion Criteria:
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 × 10^9/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 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).
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.
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There is 1 Location for this study
Burbank California, , United States
La Jolla California, , United States
Los Angeles California, , United States
Santa Maria California, , United States
Denver Colorado, , United States
Melbourne Florida, , United States
West Palm Beach Florida, , United States
Atlanta Georgia, , United States
Indianapolis Indiana, , United States
Bethesda Maryland, , United States
Rockville Maryland, , United States
Ann Arbor Michigan, , United States
Kansas City Missouri, , United States
Hackensack New Jersey, , United States
Bronx New York, , United States
New York New York, , United States
New York New York, , United States
Winston-Salem North Carolina, , United States
Canton Ohio, , United States
Cincinnati Ohio, , United States
Pittsburgh Pennsylvania, , United States
Greenville South Carolina, , United States
Nashville Tennessee, , United States
Houston Texas, , United States
Houston Texas, , United States
Temple Texas, , United States
Salt Lake City Utah, , United States
Camperdown New South Wales, , Australia
Darlinghurst New South Wales, , Australia
Kogarah New South Wales, , Australia
Liverpool New South Wales, , Australia
Saint Leonards New South Wales, , Australia
Waratah New South Wales, , Australia
Westmead New South Wales, , Australia
Herston Queensland, , Australia
South Brisbane Queensland, , Australia
South Brisbane Queensland, , Australia
South Brisbane Queensland, , Australia
Adelaide South Australia, , Australia
Woodville South Australia, , Australia
Box Hill Victoria, , Australia
Clayton Victoria, , Australia
East Melbourne Victoria, , Australia
Footscray Victoria, , Australia
Melbourne Victoria, , Australia
St. Albans Victoria, , Australia
Fremantle Western Australia, , Australia
Perth Western Australia, , Australia
Innsbruck Tyrol, , Austria
Linz Upper Austria, , Austria
Wien Vienna, , Austria
Leuven Flemish Brabant, , Belgium
Yvoir Namur, , Belgium
Ghent Oost-vlaanderen, , Belgium
Antwerp , , Belgium
Brussels , , Belgium
Brussels , , Belgium
Natal RIO Grande DO Norte, , Brazil
Porto Alegre RIO Grande DO SUL, , Brazil
Porto Alegre RIO Grande DO SUL, , Brazil
Porto Alegre RIO Grande DO SUL, , Brazil
Campinas SAO Paulo, , Brazil
Rio de Janeiro , , Brazil
Rio de Janeiro , , Brazil
Rio de Janeiro , , Brazil
São Paulo , , Brazil
Sofia Sofiya, , Bulgaria
Sofia Sofiya, , Bulgaria
Plovdiv , , Bulgaria
Varna , , Bulgaria
Edmonton Alberta, , Canada
Kelowna British Columbia, , Canada
Saint John New Brunswick, , Canada
Halifax Nova Scotia, , Canada
London Ontario, , Canada
Ottawa Ontario, , Canada
Windsor Ontario, , Canada
Montréal Quebec, , Canada
Praha 10 Praha, , Czechia
Olomouc Severomoravsky KRAJ, , Czechia
Ostrava Severomoravsky KRAJ, , Czechia
Hradec Kralové Vychodocesky KRAJ, , Czechia
Brno , , Czechia
Praha , , Czechia
Bayonne Aquitaine, , France
Brest Cedex Bretagne, , France
Rennes Cedex 9 Bretagne, , France
Nantes Cedex 1, , France
Rouen Cedex 1 Haute-normandie, , France
Le Chesnay Ile-de-france, , France
Paris Ile-de-france, , France
Paris Ile-de-france, , France
Lille Cedex NORD Pas-de-calais, , France
Nantes cedex 1 PAYS DE LA Loire, , France
Marseille Cedex 9 Provence Alpes COTE D'azur, , France
Pierre Bénite Cedex Rhone-alpes, , France
Heidelberg Baden-wuerttemberg, , Germany
Tübingen Baden-wuerttemberg, , Germany
Ulm Baden-wuerttemberg, , Germany
Würzburg Bayern, , Germany
Hannover Niedersachsen, , Germany
Aachen Nordrhein-westfalen, , Germany
Münster Nordrhein-westfalen, , Germany
Mainz Rheinland-pfalz, , Germany
Homburg / Saar Saarland, , Germany
Chemnitz Sachsen, , Germany
Dresden Sachsen, , Germany
Leipzig Sachsen, , Germany
Jena Thuringen, , Germany
Freiburg , , Germany
Hamburg , , Germany
Athens Attica, , Greece
Kecskemét Bacs-kiskun, , Hungary
Pécs Baranya, , Hungary
Szeged Csongrad, , Hungary
Debrecen Hajdu-bihar, , Hungary
Budapest , , Hungary
Kaposvár , , Hungary
Kaposvár , , Hungary
Haifa , , Israel
Jerusalem , , Israel
Kfar Saba , , Israel
Tel Aviv , , Israel
Tel Hashomer , , Israel
Rionero in Vulture Potenza, , Italy
Orbassano Torino, , Italy
Ancona , , Italy
Bologna , , Italy
Brescia , , Italy
Genova , , Italy
Novara , , Italy
Piacenza , , Italy
Pisa , , Italy
Roma , , Italy
Roma , , Italy
Roma , , Italy
Siena , , Italy
Torino , , Italy
Nagoya City Aichi, , Japan
Toyohashi Aichi, , Japan
Fukuoka-city Fukuoka, , Japan
Ogaki City Gifu, , Japan
Maebashi Gunma, , Japan
Shibukawa Gunma, , Japan
Sapporo Hokkaido, , Japan
Kobe Hyogo, , Japan
Isehara Kanagawa, , Japan
Niigata-city Niigata, , Japan
Suita Osaka, , Japan
Kawagoe Saitama, , Japan
Utsunomiya Tochigi, , Japan
Chuo-ku Tokyo, , Japan
Koto-ku Tokyo, , Japan
Shinagawa Tokyo, , Japan
Shinjuku Tokyo, , Japan
Tachikawa Tokyo, , Japan
Fukuoka , , Japan
Kyoto , , Japan
Kyoto , , Japan
Okayama , , Japan
Tokushima , , Japan
Tokyo , , Japan
Incheon Gyeonggi-Do, , Korea, Republic of
Seongnam-si Gyeonggi-do, , Korea, Republic of
Busan Gyeongsangnam-Do, , Korea, Republic of
Daegu , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
North Shore City Auckland, , New Zealand
Otahuhu Auckland, , New Zealand
Grafton Aukland, , New Zealand
Christchurch , , New Zealand
Dunedin , , New Zealand
Torun Kujawsko-Pomorskie, , Poland
Zamosc Lubelskie, , Poland
Krakow Malopolskie, , Poland
Warszawa Mazowieckie, , Poland
Gdansk Pomorskie, , Poland
Chorzów Slaskie, , Poland
Poznan Wielkopolskie, , Poland
Bucharest Bucuresti, , Romania
Brasov , , Romania
Brasov , , Romania
Bucuresti , , Romania
Iasi , , Romania
Izhevsk , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Ryazan , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Samara , , Russian Federation
Singapore , , Singapore
Singapore , , Singapore
Singapore , , Singapore
Bratislava , , Slovakia
Palma de Mallorca Baleares, , Spain
Badalona Barcelona, , Spain
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Salamanca , , Spain
Sevilla , , Spain
Valencia , , Spain
Kaohsiung , , Taiwan
Taichung , , Taiwan
Tainan , , Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
Tao-Yuan , , Taiwan
Bangkok Bangkok Metropolis, , Thailand
Bangkok Bangkok Metropolis, , Thailand
Khon Kaen , , Thailand
Dnepropetrovsk Dnipropretrovsk, , Ukraine
Kharkov Kharkiv, , Ukraine
Cherkassy , , Ukraine
Dnipropetrovsk , , Ukraine
Donetsk , , Ukraine
Khmelnytsky , , Ukraine
Khmelnytsky , , Ukraine
Kiev , , Ukraine
Kyiv , , Ukraine
Lviv , , Ukraine
Lviv , , Ukraine
Mykolayiv , , Ukraine
London England, , United Kingdom
London England, , United Kingdom
Manchester England, , United Kingdom
Nottingham England, , United Kingdom
Oxford England, , United Kingdom
Plymouth England, , United Kingdom
Sheffield England, , United Kingdom
Surrey England, , United Kingdom
Wolverhampton England, , United Kingdom
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