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

8. September 2022 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

792

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Arzneimittel: Lenalidomid
25 mg oral an den Tagen 1–21
Andere Namen:
  • Revlimid
Arzneimittel: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Experimental: 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.
Arzneimittel: Lenalidomid
25 mg oral an den Tagen 1–21
Andere Namen:
  • Revlimid
Arzneimittel: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Arzneimittel: Carfilzomib
20 mg/m², 27 mg/m² intravenously
Andere Namen:
  • PR-171
  • Kyprolis®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free Survival (PFS)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Amgen

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

14. Juli 2010

Primärer Abschluss (Tatsächlich)

16. Juni 2014

Studienabschluss (Tatsächlich)

5. Dezember 2017

Studienanmeldedaten

Zuerst eingereicht

2. März 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. März 2010

Zuerst gepostet (Schätzen)

4. März 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. September 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. September 2022

Zuletzt verifiziert

1. September 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

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  • PX-171-009

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