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Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

8 сентября 2022 г. обновлено: Amgen

A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for adults with relapsed multiple myeloma. Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd. Randomization will be stratified by β2 microglobulin levels (< vs ≥ 2.5 mg/L), prior bortezomib (no vs yes), and prior lenalidomide (no vs yes). Participants will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first).

Тип исследования

Интервенционный

Регистрация (Действительный)

792

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австрия
      • Wien, Австрия, 1090
        • Medizinische Universität Wien
      • Wien, Австрия, 1171
        • Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie
  • Бельгия
      • Antwerpen, Бельгия, 2060
        • Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
      • Brugge, Бельгия, 8000
        • AZ Sint-Jan AV
      • Brussels, Бельгия, 1090
        • UZ Brussel
      • Bruxelles, Бельгия, 1000
        • Institut Jules Bordet
      • Bruxelles, Бельгия, 1200
        • Cliniques Universitaires Saint-Luc
      • Leuven, Бельгия, 3000
        • UZ Leuven
  • Болгария
      • Pleven, Болгария, 5800
        • University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"
      • Plovdiv, Болгария, 4002
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi"
      • Sofia, Болгария, 1606
        • Military Medical Academy Multiprofile Hospital for Active Treatment
      • Sofia, Болгария, 1756
        • Specialized Hospital for Active Treatment of Hematological Diseases
      • Varna, Болгария, 9010
        • Multiprofile Hospital for Active Treatment "Sveta Marina"
  • Венгрия
      • Budapest, Венгрия, H-1097
        • St. Istvan and St. Laszlo Hospital of Budapest
      • Debrecen, Венгрия, H-4032
        • University of Debrecen, Medical and Health Science Center
      • Gyor, Венгрия, H-9032
        • Petz Aladar County Teaching Hospital
      • Gyula, Венгрия, H-5700
        • Bekes County Pandy Kalman Hospital
      • Kaposvar, Венгрия, H-7400
        • Kaposi Mór County Teaching Hospital
      • Pecs, Венгрия, H-7624
        • University of Pécs
      • Szeged, Венгрия, H-6720
        • University of Szeged, Albert Szent-Gyorgi Clinical Center
  • Германия
      • Dusseldorf, Германия, 40225
        • University of Düsseldorf
      • Frankfurt am Main, Германия, 60488
        • Krankenhaus Nordwest
      • Hamburg, Германия, 20246
        • University of Hamburg-Eppendorf
      • Heidelberg, Германия, 69120
        • Universität Heidelberg
      • Koblenz, Германия, 56068
        • Stiftungsklinikum Mittelrhein
      • Munchen, Германия, 81377
        • LMU Klinikum der Universität
      • Munster, Германия, 48129
        • Universitatsklinikum Munster
      • Wurzburg, Германия, 97080
        • Universitätsklinikum Würzburg
  • Греция
      • Athens, Греция, 11528
        • Alexandra Hospital
      • Patras, Греция, 26500
        • University General Hospital of Patras
  • Израиль
      • Haifa, Израиль, 31096
        • Rambam Medical Center
      • Jerusalem, Израиль, 91120
        • Hadassah Medical Center, Ein Kerem
      • Nahariya, Израиль, 22100
        • Western Gailee Hospital - Nahariya
      • Petach Tikva, Израиль, 49100
        • Rabin Medical Center
      • Ramat Gan, Израиль, 52621
        • The Chaim Sheba Medical Center
      • Rehovot, Израиль, 76100
        • Kaplan Medical Center
  • Испания
      • Badalona, Испания, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Испания, 08036
        • Hospital Clinic I Provincial
      • Salamanca, Испания, 37007
        • Hospital Universitario de Salamanca
      • San Sebastian, Испания, 20014
        • Hospital Donostia
      • Valencia, Испания, 46026
        • Hospital Universitario y Politeecnico La Fe
      • Zaragoza, Испания, 50009
        • Hospital Universitario Miguel Servet
  • Италия
      • Milano, Италия, 20162
        • Azienda Ospedallera Niguarda Ca Granda
      • Novara, Италия, 28100
        • Azienda Ospedllero Maggiore della Carita
      • Pisa, Италия, 56216
        • Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main
      • Roma, Италия, 00144
        • Ospedale S. Eugenio
      • Torino, Италия, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Канада
    • Alberta
      • Calgary, Alberta, Канада, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Канада, T6G 1Z2
        • University of Alberta, Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Канада, V5Z 1M9
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Канада, R3E 0V9
        • Cancer Care Manitoba
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Канада, A1B 3V6
        • General Hospital, Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Канада, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Канада, H3A 1A1
        • McGill University Health Center, Royal Victoria Hospital
      • Montreal, Quebec, Канада, H3T 1E2
        • Sir Mortimer B. Davis - Jewish General Hospital
  • Нидерланды
      • Rotterdam, Нидерланды, 3015 CE
        • Erasmus MC, Department of Haematology
  • Польша
      • Gdansk, Польша, 80-952
        • University Clinical Centre, Department of Hematologii Transplantologii
      • Gorzow Wielkopolski, Польша, 66-400
        • Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.
      • Katowice, Польша, 40-027
        • Independent Public Teaching Hospital of Medical University of Silesia in Katowice
      • Lodz, Польша, 93-510
        • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
      • Suwalki, Польша, 16-400
        • Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach
      • Torun, Польша, 87-100
        • Nicolaus Copernicus Municipal Specialist Hospital
      • Warszawa, Польша, 02-781
        • Maria Sklodowska-Curie Institute of Oncology
      • Zamosc, Польша, 22-400
        • Zamojski Non-Public Hospital
  • Российская Федерация
      • Izhevsk, Российская Федерация, 426039
        • First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
      • Moscow, Российская Федерация, 115478
        • Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center
      • Moscow, Российская Федерация, 125101
        • Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin
      • Moscow, Российская Федерация, 125167
        • Federal State Budget Institution: Hematology Research Center under MoH
      • St. Petersburg, Российская Федерация, 191024
        • FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B
      • St. Petersburg, Российская Федерация, 197022
        • State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov
      • St. Petersburg, Российская Федерация, 197101
        • SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant
      • St. Petersburg, Российская Федерация, 197341
        • Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare
    • Komi Republic
      • Syktyvkar, Komi Republic, Российская Федерация, 167904
        • State Medical Institution Komi Republican Oncological Center
  • Румыния
      • Bucharest, Румыния, 022328
        • Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation
      • Bucharest, Румыния, 030-171
        • Coltea Clinical Hospital
      • Bucharest, Румыния, 050098
        • Bucharest University Emergency Hospital
      • Iasi, Румыния, 700483
        • Regional Institute of Iasi
  • Сербия
      • Belgrade, Сербия, 11000
        • Clinical Center of Serbia, Clinic of Hematology
      • Belgrade, Сербия, 11000
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Сербия, 11000
        • Military Medical Academy, Clinic of Hematology
      • Nis, Сербия, 18 000
        • Clinical Center Nis, Clinic of Hematology
      • Novi Sad, Сербия, 21 000
        • Clinical Center of Vojvodina, Clinic of Hematology
  • Соединенное Королевство
      • London, Соединенное Королевство, SW17 0QT
        • St. Georges Hospital
      • London, Соединенное Королевство, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, Соединенное Королевство, NW3 2QG
        • Royal Free Hampstead
      • Nottingham, Соединенное Королевство, NG5 1PB
        • Nottingham University Hospitals (City Campus)
      • Sutton, Соединенное Королевство, SM2 5PT
        • Royal Marsden Hospital
      • Wolverhampton, Соединенное Королевство, WV10 OQP
        • The Royal Wolverhampton Hospital NHS Trust
  • Соединенные Штаты
    • Arizona
      • Scottsdale, Arizona, Соединенные Штаты, 85259
        • Mayo Clinic
    • California
      • Burbank, California, Соединенные Штаты, 91505
        • Providence St. Joseph Medical Center
      • Santa Rosa, California, Соединенные Штаты, 94503
        • St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare
      • Stanford, California, Соединенные Штаты, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, Соединенные Штаты, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • Lecanto, Florida, Соединенные Штаты, 34461
        • Cancer and Blood Disease Center
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46202
        • Indiana University Health Melvin and Bren Simon Cancer Center
    • Kansas
      • Kansas City, Kansas, Соединенные Штаты, 66160
        • University of Kansas Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Соединенные Штаты, 48109
        • The University of Michigan - Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, Соединенные Штаты, 55905
        • Mayo Clinic
    • New Jersey
      • Hackensack, New Jersey, Соединенные Штаты, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • New York, New York, Соединенные Штаты, 10016
        • NYU Clinical Cancer Center
      • New York, New York, Соединенные Штаты, 10021
        • Weill Cornell Medical College
    • Tennessee
      • Chattanooga, Tennessee, Соединенные Штаты, 37404
        • Associates in Oncology and Hematology
    • Texas
      • Amarillo, Texas, Соединенные Штаты, 79106
        • The Don & Sybil Harrington Cancer Center
      • Dallas, Texas, Соединенные Штаты, 75246
        • Baylor Sammons Cancer Center
      • Dallas, Texas, Соединенные Штаты, 75390-8565
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, Соединенные Штаты, 77030
        • The University of Texas, MD Anderson Cancer Center
      • Temple, Texas, Соединенные Штаты, 76508
        • Scott and White Memorial Hospital
    • Washington
      • Seattle, Washington, Соединенные Штаты, 98109
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, Соединенные Штаты, 53226
        • Froedtert & Medical College of Wisconsin
  • Франция
      • Clamart, Франция, 92140
        • Hospital Antoine Beclere
      • Le Mans, Франция, 72000
        • Clinique Victor Hugo - Centre Jean Bernard
      • Lille, Франция, 59037
        • Hôpital Claude Huriez
      • Mulhouse, Франция, 68070
        • CH de Mulhouse, Hopital Emile Muller
      • Nantes, Франция, 44093
        • CHU Nantes Hôtel Dieu
      • Paris, Франция, 75012
        • Hopital Saint-Antoine
      • Paris, Франция, 75015
        • Groupe Hospitalier Necker - Enfants Malades
      • Toulouse, Франция, 31100
        • Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)
      • Vandoeuvre-Les-Nancy, Франция, 54511
        • Hôpitaux de Brabois
  • Чехия
      • Brno, Чехия, 625 00
        • University Hospital Brno, Department of Internal Medicine - Hematooncology
      • Hradec Kralove, Чехия, 500 05
        • University Hospital Hradec Kralove
      • Olomouc, Чехия, 775 20
        • University Hospital Olomouc
      • Praha 10, Чехия, 100 34
        • University Hospital Kralovske Vinohrady - Prague
      • Praha 2, Чехия, 128 08
        • General University Hospital Prague
  • Швеция
      • Goteborg, Швеция, SE-41345
        • Sahlgrenska Universitetssjukhuset
      • Stockholm, Швеция, SE-14186
        • Karolinska Universitetsjukhuset i Huddinge
      • Stockholm, Швеция, SE-17176
        • Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Symptomatic multiple myeloma

  2. Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization):

    • Serum M-protein ≥ 0.5 g/dL
    • Urine Bence-Jones protein ≥ 200 mg/24 hours
    • For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL)
  3. Prior treatment with at least one, but no more than three, regimens for multiple myeloma
  4. Documented relapse or progressive disease on or after any regimen
  5. Achieved a response to at least one prior regimen
  6. Age ≥ 18 years
  7. Life expectancy ≥ 3 months
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  9. Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization
  10. Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization
  11. Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization
  12. Platelet count ≥ 50 × 10^9/L (≥ 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization
  13. Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization
  14. Written informed consent in accordance with federal, local, and institutional guidelines
  15. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
  16. Male subjects must agree to practice contraception

Exclusion Criteria:

  1. If previously treated with bortezomib (alone or in combination), progression during treatment

  2. If previously treated with a lenalidomide and dexamethasone (len/dex) combination:

    • Progression during the first 3 months of initiating treatment
    • Any progression during treatment if the len/dex combination was the subject's most recent line of therapy
  3. Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
  4. Prior carfilzomib treatment
  5. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  6. Waldenström's macroglobulinemia or IgM myeloma
  7. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
  8. Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
  9. Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
  10. Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
  11. Pregnant or lactating females
  12. Major surgery within 21 days prior to randomization
  13. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
  14. Known human immunodeficiency virus infection
  15. Active hepatitis B or C infection
  16. Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
  17. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
  18. Other malignancy, including myelodysplastic syndromes (MDS), 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 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 or benign tumors of the adrenal or pancreas
  19. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
  20. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
  21. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
  22. Ongoing graft-vs-host disease
  23. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization
  24. 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Lenalidomide and Dexamethasone (Rd)
Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22.
Лекарство: Леналидомид
25 мг перорально в дни 1-21
Другие имена:
  • Ревлимид
Лекарство: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Экспериментальный: Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, escalating to 27 mg/m² on days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 from cycle 1 through cycle 18 and from cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 from cycle 1 through cycle 18 and from cycle 19 and higher.
Лекарство: Леналидомид
25 мг перорально в дни 1-21
Другие имена:
  • Ревлимид
Лекарство: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Лекарство: Carfilzomib
20 mg/m², 27 mg/m² intravenously
Другие имена:
  • ПР-171
  • Кипролис®

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Progression-free Survival (PFS)
Временное ограничение: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Survival
Временное ограничение: From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
Overall Response Rate
Временное ограничение: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Disease Control Rate
Временное ограничение: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Duration of Response
Временное ограничение: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
Duration of Disease Control
Временное ограничение: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Временное ограничение: Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18

Соавторы и исследователи

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Спонсор

Amgen

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Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

14 июля 2010 г.

Первичное завершение (Действительный)

16 июня 2014 г.

Завершение исследования (Действительный)

5 декабря 2017 г.

Даты регистрации исследования

Первый отправленный

2 марта 2010 г.

Впервые представлено, что соответствует критериям контроля качества

2 марта 2010 г.

Первый опубликованный (Оценивать)

4 марта 2010 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 сентября 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

8 сентября 2022 г.

Последняя проверка

1 сентября 2022 г.

Дополнительная информация

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Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • PX-171-009

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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