Carfilzomib in Combination With Dexamethasone (Kd) in Chinese Patients With Relapsed & Refractory Multiple Myeloma
An Open-label, Single-arm, Phase 3 Study of Carfilzomib in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma in China
2 other identifiers
interventional
126
1 country
17
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and overall response rate of carfilzomib in combination with dexamethasone for the treatment of multiple myeloma in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Typical duration for phase_3
17 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
November 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 24, 2017
CompletedStudy Start
First participant enrolled
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2018
CompletedResults Posted
Study results publicly available
November 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2021
CompletedMay 25, 2022
April 1, 2022
1.6 years
November 11, 2016
November 4, 2019
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR) After at Least 6 Cycles of Treatment Assessed by the Independent Review Committee
ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria. sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \< 5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein \<100 mg/24 hrs. If disease measurable only by SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). PR: ≥ 50% reduction of serum M-protein and ≥ 90% reduction in urine M-protein or to \< 200 mg/24 hrs, or a ≥ 50% decrease in dFLC. A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline.
Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 5 November 2018; median follow-up time for progression was 8.9 months.
Secondary Outcomes (21)
Overall Response Rate (ORR) After at Least 6 Cycles of Treatment Assessed by the Investigator
Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 05 November 2018; median follow-up time for progression was 10.3 months.
Overall Response Rate After at Least 12 Cycles of Treatment Assessed by the Independent Review Committee
Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 12 cycles or discontinued treatment; the data cut-off date was 15 March 2019; median follow-up time for progression was 12.8 months.
Overall Response Rate After at Least 12 Cycles of Treatment Assessed by the Investigator
Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 12 cycles or discontinued treatment; the data cut-off date was 15 March 2019; median follow-up time for progression was 13.1 months.
Clinical Benefit Rate After at Least 6 Cycles of Treatment Assessed by the Independent Review Committee
Response was assessed every 28 days until disease progression; CBR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 05 November 2018; median follow-up time for progression was 8.9 months.
Clinical Benefit Rate After at Least 6 Cycles of Treatment Assessed by the Investigator
Response was assessed every 28 days until disease progression; CBR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 05 November 2018; median follow-up time for progression was 10.3 months.
- +16 more secondary outcomes
Study Arms (1)
Carfilzomib with Dexamethasone
EXPERIMENTALParticipants will receive carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants will also receive 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle. Participants will receive treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, non-compliance, or intercurrent illness or worsening of a chronic condition, whichever occurs first.
Interventions
20 mg intravenous (IV) or oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23 in 28-day cycles.
Infusion of IV carfilzomib on days 1, 2, 8, 9, 15 and 16 in each 28-day cycle.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Onyx Therapeutics, Inc.collaborator
Study Sites (17)
Beijing Chao Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangzhou First Peoples Hospital
Guangzhou, Guangdong, 510180, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuang University
Chengdu, Sichuan, 610041, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Peking Union Medical College Hospital
Beijing, 100730, China
Shanghai Changzheng Hospital
Shanghai, 200003, China
Related Publications (1)
Du J, Fang B, Li J, Jin J, Wang S, Zou D, Cai Z, Wang H, Hu J, Li W, Fu C, Shao Z, Xia Z, Liu P, Niu T, Tang ET, Kimball AS, Hou J, Chen W. A study of carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma in China. Int J Hematol. 2021 Mar;113(3):422-429. doi: 10.1007/s12185-020-03044-z. Epub 2021 Jan 3.
PMID: 33389656BACKGROUND
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2016
First Posted
January 24, 2017
Study Start
March 31, 2017
Primary Completion
November 5, 2018
Study Completion
June 4, 2021
Last Updated
May 25, 2022
Results First Posted
November 21, 2019
Record last verified: 2022-04
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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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