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

8 settembre 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

792

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Droga: Lenalidomide
25 mg per via orale nei giorni 1-21
Altri nomi:
  • Revimid
Droga: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Sperimentale: 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.
Droga: Lenalidomide
25 mg per via orale nei giorni 1-21
Altri nomi:
  • Revimid
Droga: Dexamethasone
40 mg orally or IV on days 1, 8, 15, 22
Droga: Carfilzomib
20 mg/m², 27 mg/m² intravenously
Altri nomi:
  • PR-171
  • Kyprolis®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 luglio 2010

Completamento primario (Effettivo)

16 giugno 2014

Completamento dello studio (Effettivo)

5 dicembre 2017

Date di iscrizione allo studio

Primo inviato

2 marzo 2010

Primo inviato che soddisfa i criteri di controllo qualità

2 marzo 2010

Primo Inserito (Stima)

4 marzo 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 settembre 2022

Ultimo verificato

1 settembre 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PX-171-009

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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