Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.
CANDOR
A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
2 other identifiers
interventional
466
18 countries
111
Brief Summary
Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2017
Longer than P75 for phase_3
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 18, 2017
CompletedStudy Start
First participant enrolled
June 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2019
CompletedResults Posted
Study results publicly available
September 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedMay 9, 2025
May 1, 2025
2.1 years
May 9, 2017
July 13, 2020
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only)
Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent.
From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Secondary Outcomes (13)
Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only)
From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee
12 Months (8- to 13-month window)
Overall Survival
Up to 58 months after the first participant was enrolled (at FA DCO, a median of 40.29 weeks of treatment [any study drug] in the Kd group and 79.29 weeks of treatment [any study drug] in the KdD group; FA DCO was 15 Apr 2022)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only)
From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
- +8 more secondary outcomes
Study Arms (2)
Kd - Carfilzomib and Dexamethasone
ACTIVE COMPARATORCarfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
KdD - Carfilzomib, Dexamethasone and Daratumumab
EXPERIMENTALCarfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg was further continued on Cycles 7+: day 1 only.
Interventions
Commercially available oral and IV formulas were obtained by investigative sites. Amgen supplied IV or PO dexa for some countries (Poland, Hungry, Romania, Bulgaria, Korea). Dosage modification rules applied based on participant age (participants \> 75 years were given lower doses), dexa-related toxicities, and discontinuation of carfilzomib.
Daratumumab was supplied as a concentrated solution for infusion in single-use vials.
Carfilzomib for infusion was supplied as a lyophilized, sterile product in single-use vials. The lyophilized product was reconstituted with preservative-free sterile water for injection, the reconstituted solution contained carfilzomib 2 mg/mL. IV injections lasted approximately 30 minutes. Dose could be modified based on a \>20% change in body weight or toxicity.
Eligibility Criteria
You may qualify if:
- Criteria 1 Relapsed or progressive multiple myeloma after last treatment
- Criteria 2 Males or females ≥ 18 years of age
- Criteria 3 Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:
- IgG multiple myeloma: serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL,
- IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL,
- urine M-protein ≥ 200 mg/24 hours,
- in subjects without measurable serum or urine M- protein, serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
- Criteria 4 Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy
- Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a partial response (PR) to most recent therapy with carfilzomib, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodies during this 6-month carfilzomib treatment free interval)
- Criteria 6 Prior therapy with anti-CD38 antibodies is allowed as long as the patient had at least a PR to most recent therapy with CD38 antibody, was not removed due to toxicity, did not relapse within 60 days from intensive treatment (at least every other week) of CD38 antibody therapy, and will have at least a 6 month CD38 antibody treatment-free interval from last dose received until first study treatment
You may not qualify if:
- Criteria 1 Waldenström macroglobulinemia
- Criteria 2 Multiple myeloma of IgM subtype
- Criteria 3 POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Criteria 4 Plasma cell leukemia (\> 2.0 \* 10\^9/L circulating plasma cells by standard differential)
- Criteria 5 Myelodysplastic syndrome
- Criteria 6 Known moderate or severe persistent asthma within the past 2 years
- Criteria 7 Known chronic obstructive pulmonary disease (COPD) with a FEV1 \< 50% of predicted normal
- Criteria 8 Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of \> 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (113)
Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center - Multiple Myeloma Research Consortium
Chicago, Illinois, 60637-6613, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, 10021, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Gabrail Cancer Center, LLC
Dover, Ohio, 44622, United States
Charleston Oncology
Charleston, South Carolina, 29414, United States
Baylor Charles A Sammons Cancer Center at Dallas
Dallas, Texas, 75246, United States
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
St Vincents Hospital Sydney
St Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Epworth Healthcare
East Melbourne, Victoria, 3002, Australia
St Vincents Hospital Melbourne
Fitzroy, VIC, Victoria, 3065, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, 3220, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Grand Hôpital de Charleroi
Charleroi, 6000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia, 1431, Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia, 1756, Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, 708 52, Czechia
Fakultni nemocnice Plzen
Pilsen, 304 60, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Centre Hospitalier Départemental les Oudairies
La Roche-sur-Yon, 85925, France
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay, 78157, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, 59037, France
Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, 86021, France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, 54511, France
General Hospital Evangelismos
Athens, 10676, Greece
Alexandra Hospital
Athens, 11528, Greece
General University Hospital of Patras Panagia i Voithia
Pátrai, 26504, Greece
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki, 54007, Greece
Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6725, Hungary
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
Tesshokai Kameda General Hospital
Kamogawa-shi, Chiba, 296-8602, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Ogaki Municipal Hospital
Ogaki-shi, Gifu, 503-8502, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa-shi, Gunma, 377-0280, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Saitama Medical Center
Kawagoe-shi, Saitama, 350-8550, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
Tokushima Prefectural Central Hospital
Tokushima, Tokushima, 770-8539, Japan
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935, Japan
InterHem
Bialystok, 15-732, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie
Chorzów, 41-500, Poland
Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli
Lublin, 20-090, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu
Poznan, 60-569, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-367, Poland
Policlinica de Diagnostic Rapid
Brasov, 500152, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Fundeni Clinical Institute
Bucharest, 022328, Romania
Coltea Clinical Hospital
Bucharest, 030171, Romania
Bucharest Emergency University Hospital
Bucharest, 050098, Romania
Profesor Dr Ion Chiricuta Institut of Oncology
Cluj-Napoca, 400124, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko
Nizhny Novgorod, 603126, Russia
SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov
Petrozavodsk, 185019, Russia
State Budget Educational Institution of High Professional Skills Samara State Medical University
Samara, 443079, Russia
Clinic of professional pathology and hematology
Saratov, 410028, Russia
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hospital Clinico Universitario de Salamanca
Salamanca, Castilla León, 37007, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Cataluña, 08916, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña, 08036, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06590, Turkey (Türkiye)
Ege University Faculty of Medicine
Izmir, 35040, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, 55139, Turkey (Türkiye)
St James University Hospital
Leeds, LS9 7TF, United Kingdom
University College London Hospital
London, NW1 2PG, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
Related Publications (9)
Quach H, Nooka A, Samoylova O, Venner CP, Kim K, Facon T, Spencer A, Usmani SZ, Grosicki S, Suzuki K, Delimpasi S, Weisel K, Obreja M, Zahlten-Kumeli A, Mateos MV. Carfilzomib, dexamethasone and daratumumab in relapsed or refractory multiple myeloma: results of the phase III study CANDOR by prior lines of therapy. Br J Haematol. 2021 Aug;194(4):784-788. doi: 10.1111/bjh.17541. Epub 2021 May 28. No abstract available.
PMID: 34046887BACKGROUNDSiegel D, Weisel K, Zahlten-Kumeli A, Medhekar R, Ding B, Leleu X. Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma. Leuk Lymphoma. 2021 Dec;62(12):3002-3010. doi: 10.1080/10428194.2021.1941927. Epub 2021 Jun 26.
PMID: 34180331BACKGROUNDSuzuki K, Min CK, Kim K, Lee JJ, Shibayama H, Ko PS, Huang SY, Li SS, Ding B, Khurana M, Iida S. Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial. Int J Hematol. 2021 Dec;114(6):653-663. doi: 10.1007/s12185-021-03204-9. Epub 2021 Aug 19.
PMID: 34410635BACKGROUNDUsmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Gavriatopoulou M, Oriol A, Rabin N, Nooka A, Qi M, Beksac M, Jakubowiak A, Ding B, Zahlten-Kumeli A, Yusuf A, Dimopoulos M. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study. Lancet Oncol. 2022 Jan;23(1):65-76. doi: 10.1016/S1470-2045(21)00579-9. Epub 2021 Dec 3.
PMID: 34871550BACKGROUNDLandgren O, Weisel K, Rosinol L, Touzeau C, Turgut M, Hajek R, Mollee P, Kim JS, Shu N, Hu X, Li C, Usmani SZ. Subgroup analysis based on cytogenetic risk in patients with relapsed or refractory multiple myeloma in the CANDOR study. Br J Haematol. 2022 Sep;198(6):988-993. doi: 10.1111/bjh.18233. Epub 2022 May 24.
PMID: 35608261BACKGROUNDDimopoulos M, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Yang H, Klippel Z, Zahlten-Kumeli A, Usmani SZ. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. Lancet. 2020 Jul 18;396(10245):186-197. doi: 10.1016/S0140-6736(20)30734-0.
PMID: 32682484BACKGROUNDLeleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.
PMID: 33112184BACKGROUNDUsmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Shu X, Li C, Dimopoulos M. Final analysis of carfilzomib, dexamethasone, and daratumumab vs carfilzomib and dexamethasone in the CANDOR study. Blood Adv. 2023 Jul 25;7(14):3739-3748. doi: 10.1182/bloodadvances.2023010026.
PMID: 37163358BACKGROUNDWeisel K, Mateos MV, Landgren O, Leleu X, Quach H, Bennett L, Talpes M, Majer I, Patel S, Usmani SZ. Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma Treated With Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone: An Analysis of Patient-Reported Outcomes From the Phase 3 CANDOR Trial. Clin Lymphoma Myeloma Leuk. 2025 Aug;25(8):590-605. doi: 10.1016/j.clml.2025.02.005. Epub 2025 Feb 19.
PMID: 40087058BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 18, 2017
Study Start
June 13, 2017
Primary Completion
July 14, 2019
Study Completion
April 15, 2022
Last Updated
May 9, 2025
Results First Posted
September 11, 2020
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request