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

2022年9月8日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (実際)

792

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
薬：レナリドミド
1～21日目に25mgを経口投与
他の名前：
  • レブラミド
薬：Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
実験的：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.
薬：レナリドミド
1～21日目に25mgを経口投与
他の名前：
  • レブラミド
薬：Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
薬：Carfilzomib
20 mg/m², 27 mg/m² intravenously
他の名前：
  • PR-171
  • カイプロリス®

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression-free Survival (PFS)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Amgen

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2010年7月14日

一次修了 (実際)

2014年6月16日

研究の完了 (実際)

2017年12月5日

試験登録日

最初に提出

2010年3月2日

QC基準を満たした最初の提出物

2010年3月2日

最初の投稿 (見積もり)

2010年3月4日

学習記録の更新

投稿された最後の更新 (実際)

2022年9月21日

QC基準を満たした最後の更新が送信されました

2022年9月8日

最終確認日

2022年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PX-171-009

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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