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

8 września 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

792

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Lek: Lenalidomid
25 mg doustnie w dniach 1-21
Inne nazwy:
  • Revlimid
Lek: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Eksperymentalny: 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.
Lek: Lenalidomid
25 mg doustnie w dniach 1-21
Inne nazwy:
  • Revlimid
Lek: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Lek: Carfilzomib
20 mg/m², 27 mg/m² intravenously
Inne nazwy:
  • PR-171
  • Kyprolis®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Progression-free Survival (PFS)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amgen

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

14 lipca 2010

Zakończenie podstawowe (Rzeczywisty)

16 czerwca 2014

Ukończenie studiów (Rzeczywisty)

5 grudnia 2017

Daty rejestracji na studia

Pierwszy przesłany

2 marca 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 marca 2010

Pierwszy wysłany (Oszacować)

4 marca 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 września 2022

Ostatnia weryfikacja

1 września 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PX-171-009

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