Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
8 septembre 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
792
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Dusseldorf, Allemagne, 40225
- University of Dusseldorf
-
Frankfurt am Main, Allemagne, 60488
- Krankenhaus Nordwest
-
Hamburg, Allemagne, 20246
- University of Hamburg-Eppendorf
-
Heidelberg, Allemagne, 69120
- Universität Heidelberg
-
Koblenz, Allemagne, 56068
- Stiftungsklinikum Mittelrhein
-
Munchen, Allemagne, 81377
- LMU Klinikum der Universität
-
Munster, Allemagne, 48129
- Universitätsklinikum Münster
-
Wurzburg, Allemagne, 97080
- Universitätsklinikum Würzburg
-
-
-
-
-
Antwerpen, Belgique, 2060
- Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
-
Brugge, Belgique, 8000
- AZ Sint-Jan AV
-
Brussels, Belgique, 1090
- UZ Brussel
-
Bruxelles, Belgique, 1000
- Institut Jules Bordet
-
Bruxelles, Belgique, 1200
- Cliniques universitaires Saint-Luc
-
Leuven, Belgique, 3000
- UZ Leuven
-
-
-
-
-
Pleven, Bulgarie, 5800
- University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"
-
Plovdiv, Bulgarie, 4002
- University Multiprofile Hospital for Active Treatment "Sveti Georgi"
-
Sofia, Bulgarie, 1606
- Military Medical Academy Multiprofile Hospital for Active Treatment
-
Sofia, Bulgarie, 1756
- Specialized Hospital for Active Treatment of Hematological Diseases
-
Varna, Bulgarie, 9010
- Multiprofile Hospital for Active Treatment "Sveta Marina"
-
-
-
-
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
-
-
-
-
-
Badalona, Espagne, 08916
- Hospital Universitario Germans Trias i Pujol
-
Barcelona, Espagne, 08036
- Hospital Clinic I Provincial
-
Salamanca, Espagne, 37007
- Hospital Universitario De Salamanca
-
San Sebastian, Espagne, 20014
- Hospital Donostia
-
Valencia, Espagne, 46026
- Hospital Universitario y Politeecnico La Fe
-
Zaragoza, Espagne, 50009
- Hospital Universitario Miguel Servet
-
-
-
-
-
Clamart, France, 92140
- Hospital Antoine Beclere
-
Le Mans, France, 72000
- Clinique Victor Hugo - Centre Jean Bernard
-
Lille, France, 59037
- Hôpital Claude Huriez
-
Mulhouse, France, 68070
- CH de Mulhouse, Hopital Emile Muller
-
Nantes, France, 44093
- CHU Nantes Hôtel Dieu
-
Paris, France, 75012
- Hôpital Saint-Antoine
-
Paris, France, 75015
- Groupe Hospitalier Necker - Enfants Malades
-
Toulouse, France, 31100
- Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)
-
Vandoeuvre-Les-Nancy, France, 54511
- Hopitaux de Brabois
-
-
-
-
-
Izhevsk, Fédération Russe, 426039
- First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
-
Moscow, Fédération Russe, 115478
- Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center
-
Moscow, Fédération Russe, 125101
- Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin
-
Moscow, Fédération Russe, 125167
- Federal State Budget Institution: Hematology Research Center under MoH
-
St. Petersburg, Fédération Russe, 191024
- FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B
-
St. Petersburg, Fédération Russe, 197022
- State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov
-
St. Petersburg, Fédération Russe, 197101
- SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant
-
St. Petersburg, Fédération Russe, 197341
- Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare
-
-
Komi Republic
-
Syktyvkar, Komi Republic, Fédération Russe, 167904
- State Medical Institution Komi Republican Oncological Center
-
-
-
-
-
Athens, Grèce, 11528
- Alexandra Hospital
-
Patras, Grèce, 26500
- University General Hospital of Patras
-
-
-
-
-
Budapest, Hongrie, H-1097
- St. Istvan and St. Laszlo Hospital of Budapest
-
Debrecen, Hongrie, H-4032
- University of Debrecen, Medical and Health Science Center
-
Gyor, Hongrie, H-9032
- Petz Aladar County Teaching Hospital
-
Gyula, Hongrie, H-5700
- Bekes County Pandy Kalman Hospital
-
Kaposvar, Hongrie, H-7400
- Kaposi Mór County Teaching Hospital
-
Pecs, Hongrie, H-7624
- University of Pecs
-
Szeged, Hongrie, H-6720
- University of Szeged, Albert Szent-Gyorgi Clinical Center
-
-
-
-
-
Haifa, Israël, 31096
- Rambam Medical Center
-
Jerusalem, Israël, 91120
- Hadassah Medical Center, Ein Kerem
-
Nahariya, Israël, 22100
- Western Gailee Hospital - Nahariya
-
Petach Tikva, Israël, 49100
- Rabin Medical Center
-
Ramat Gan, Israël, 52621
- The Chaim Sheba Medical Center
-
Rehovot, Israël, 76100
- Kaplan Medical Center
-
-
-
-
-
Milano, Italie, 20162
- Azienda Ospedallera Niguarda Ca Granda
-
Novara, Italie, 28100
- Azienda Ospedllero Maggiore della Carita
-
Pisa, Italie, 56216
- Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main
-
Roma, Italie, 00144
- Ospedale S. Eugenio
-
Torino, Italie, 10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
-
-
-
-
-
Wien, L'Autriche, 1090
- Medizinische Universität Wien
-
Wien, L'Autriche, 1171
- Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie
-
-
-
-
-
Rotterdam, Pays-Bas, 3015 CE
- Erasmus MC, Department of Haematology
-
-
-
-
-
Gdansk, Pologne, 80-952
- University Clinical Centre, Department of Hematologii Transplantologii
-
Gorzow Wielkopolski, Pologne, 66-400
- Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.
-
Katowice, Pologne, 40-027
- Independent Public Teaching Hospital of Medical University of Silesia in Katowice
-
Lodz, Pologne, 93-510
- Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
-
Suwalki, Pologne, 16-400
- Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach
-
Torun, Pologne, 87-100
- Nicolaus Copernicus Municipal Specialist Hospital
-
Warszawa, Pologne, 02-781
- Maria Sklodowska-Curie Institute of Oncology
-
Zamosc, Pologne, 22-400
- Zamojski Non-Public Hospital
-
-
-
-
-
Bucharest, Roumanie, 022328
- Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation
-
Bucharest, Roumanie, 030-171
- Coltea Clinical Hospital
-
Bucharest, Roumanie, 050098
- Bucharest University Emergency Hospital
-
Iasi, Roumanie, 700483
- Regional Institute of Iasi
-
-
-
-
-
London, Royaume-Uni, SW17 0QT
- St. Georges Hospital
-
London, Royaume-Uni, EC1A 7BE
- St. Bartholomew's Hospital
-
London, Royaume-Uni, NW3 2QG
- Royal Free Hampstead
-
Nottingham, Royaume-Uni, NG5 1PB
- Nottingham University Hospitals (City Campus)
-
Sutton, Royaume-Uni, SM2 5PT
- Royal Marsden Hospital
-
Wolverhampton, Royaume-Uni, WV10 OQP
- The Royal Wolverhampton Hospital NHS Trust
-
-
-
-
-
Belgrade, Serbie, 11000
- Clinical Center of Serbia, Clinic of Hematology
-
Belgrade, Serbie, 11000
- Clinical Hospital Center Bezanijska Kosa
-
Belgrade, Serbie, 11000
- Military Medical Academy, Clinic of Hematology
-
Nis, Serbie, 18 000
- Clinical Center Nis, Clinic of Hematology
-
Novi Sad, Serbie, 21 000
- Clinical Center of Vojvodina, Clinic of Hematology
-
-
-
-
-
Goteborg, Suède, SE-41345
- Sahlgrenska Universitetssjukhuset
-
Stockholm, Suède, SE-14186
- Karolinska Universitetsjukhuset i Huddinge
-
Stockholm, Suède, SE-17176
- Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum
-
-
-
-
-
Brno, Tchéquie, 625 00
- University Hospital Brno, Department of Internal Medicine - Hematooncology
-
Hradec Kralove, Tchéquie, 500 05
- University Hospital Hradec Kralove
-
Olomouc, Tchéquie, 775 20
- University Hospital Olomouc
-
Praha 10, Tchéquie, 100 34
- University Hospital Kralovske Vinohrady - Prague
-
Praha 2, Tchéquie, 128 08
- General University Hospital Prague
-
-
-
-
Arizona
-
Scottsdale, Arizona, États-Unis, 85259
- Mayo Clinic
-
-
California
-
Burbank, California, États-Unis, 91505
- Providence St. Joseph Medical Center
-
Santa Rosa, California, États-Unis, 94503
- St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare
-
Stanford, California, États-Unis, 94305
- Stanford University
-
-
Colorado
-
Denver, Colorado, États-Unis, 80218
- Colorado Blood Cancer Institute
-
-
Florida
-
Lecanto, Florida, États-Unis, 34461
- Cancer and Blood Disease Center
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60612
- Rush University Medical Center
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46202
- Indiana University Health Melvin and Bren Simon Cancer Center
-
-
Kansas
-
Kansas City, Kansas, États-Unis, 66160
- University of Kansas Cancer Center
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109
- The University of Michigan - Comprehensive Cancer Center
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
-
-
New Jersey
-
Hackensack, New Jersey, États-Unis, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
-
-
New York
-
New York, New York, États-Unis, 10016
- Nyu Clinical Cancer Center
-
New York, New York, États-Unis, 10021
- Weill Cornell Medical College
-
-
Tennessee
-
Chattanooga, Tennessee, États-Unis, 37404
- Associates in Oncology and Hematology
-
-
Texas
-
Amarillo, Texas, États-Unis, 79106
- The Don & Sybil Harrington Cancer Center
-
Dallas, Texas, États-Unis, 75246
- Baylor Sammons Cancer Center
-
Dallas, Texas, États-Unis, 75390-8565
- UT Southwestern Medical Center at Dallas
-
Houston, Texas, États-Unis, 77030
- The University of Texas, MD Anderson Cancer Center
-
Temple, Texas, États-Unis, 76508
- Scott and White Memorial Hospital
-
-
Washington
-
Seattle, Washington, États-Unis, 98109
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, États-Unis, 53226
- Froedtert & Medical College of Wisconsin
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Symptomatic multiple myeloma
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)
- Prior treatment with at least one, but no more than three, regimens for multiple myeloma
- Documented relapse or progressive disease on or after any regimen
- Achieved a response to at least one prior regimen
- Age ≥ 18 years
- Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- 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
- Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization
- Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization
- 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
- Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization
- Written informed consent in accordance with federal, local, and institutional guidelines
- Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
- Male subjects must agree to practice contraception
Exclusion Criteria:
- If previously treated with bortezomib (alone or in combination), progression during treatment
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
- Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
- Prior carfilzomib treatment
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Waldenström's macroglobulinemia or IgM myeloma
- Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
- Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
- 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
- Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
- Pregnant or lactating females
- Major surgery within 21 days prior to randomization
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
- Known human immunodeficiency virus infection
- Active hepatitis B or C infection
- 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
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
- 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
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
- Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
- 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
- Ongoing graft-vs-host disease
- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization
- 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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
25 mg par voie orale les jours 1 à 21
Autres noms:
40 mg orally or IV on days 1, 8, 15, 22
|
|
Expérimental: 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.
|
25 mg par voie orale les jours 1 à 21
Autres noms:
40 mg orally or IV on days 1, 8, 15, 22
20 mg/m², 27 mg/m² intravenously
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-free Survival (PFS)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Dimopoulos M, Wang M, Maisnar V, Minarik J, Bensinger W, Mateos MV, Obreja M, Blaedel J, Moreau P. Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study. J Hematol Oncol. 2018 Apr 4;11(1):49. doi: 10.1186/s13045-018-0583-7.
- Avet-Loiseau H, Fonseca R, Siegel D, Dimopoulos MA, Spicka I, Masszi T, Hajek R, Rosinol L, Goranova-Marinova V, Mihaylov G, Maisnar V, Mateos MV, Wang M, Niesvizky R, Oriol A, Jakubowiak A, Minarik J, Palumbo A, Bensinger W, Kukreti V, Ben-Yehuda D, Stewart AK, Obreja M, Moreau P. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma. Blood. 2016 Sep 1;128(9):1174-80. doi: 10.1182/blood-2016-03-707596. Epub 2016 Jul 20.
- Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Ro S, Aggarwal S, Moreau P, Palumbo A. Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. Blood Cancer J. 2017 Apr 21;7(4):e554. doi: 10.1038/bcj.2017.31.
- Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Palumbo A, Obreja M, Aggarwal S, Moreau P. Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study. Br J Haematol. 2017 May;177(3):404-413. doi: 10.1111/bjh.14549. Epub 2017 Feb 17.
- Jakubowiak AJ, Campioni M, Benedict A, Houisse I, Tichy E, Giannopoulou A, Aggarwal SK, Barber BL, Panjabi S. Cost-effectiveness of adding carfilzomib to lenalidomide and dexamethasone in relapsed multiple myeloma from a US perspective. J Med Econ. 2016 Nov;19(11):1061-1074. doi: 10.1080/13696998.2016.1194278. Epub 2016 Jun 16.
- Stewart AK, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Buchanan J, Cocks K, Yang X, Xing B, Zojwalla N, Tonda M, Moreau P, Palumbo A. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma. J Clin Oncol. 2016 Nov 10;34(32):3921-3930. doi: 10.1200/JCO.2016.66.9648.
- Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.
- Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.
- Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.
- Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5.
- Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.
- Siegel DS, Dimopoulos MA, Ludwig H, Facon T, Goldschmidt H, Jakubowiak A, San-Miguel J, Obreja M, Blaedel J, Stewart AK. Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 10;36(8):728-734. doi: 10.1200/JCO.2017.76.5032. Epub 2018 Jan 17.
- Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.
- Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 juillet 2010
Achèvement primaire (Réel)
16 juin 2014
Achèvement de l'étude (Réel)
5 décembre 2017
Dates d'inscription aux études
Première soumission
2 mars 2010
Première soumission répondant aux critères de contrôle qualité
2 mars 2010
Première publication (Estimation)
4 mars 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 septembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2022
Dernière vérification
1 septembre 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Maladies hématologiques
- Troubles hémorragiques
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Myélome multiple
- Tumeurs, plasmocyte
- Effets physiologiques des médicaments
- Agents autonomes
- Agents du système nerveux périphérique
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Facteurs immunologiques
- Antiémétiques
- Agents gastro-intestinaux
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Dexaméthasone
- Lénalidomide
Autres numéros d'identification d'étude
- PX-171-009
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .