Multiple MyelomaNCT01947309
Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)
An observational study of Multiple Myeloma, run by Celgene at 17 sites in China.
Trial summary
The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Revlimid (lenalidomide)
- How many people
- 176 participants
- Where
- 17 sitesChina
- Study dates
- Nov 2013to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Chinese Patients with Multiple Myeloma Treated with Revlimid (Lenalidomide) in a Postmarketing setting
Who may be able to join
- Must understand and voluntarily sign written informed consent At least 18 years old at the time of signing informed consent Diagnosed with Multiple Myeloma Must have received at least one prior Multiple Myeloma treatment at the time of signing informed consent
Who cannot join
- None
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Peking Chao-Yang Hospital
Beijing, 100020
Peking University People's Hospital
Beijing, 100044
People's Liberation Army Hospital 307
Beijing, 100071
Beijing Hospital
Beijing, 100730
The Fisrt Hospital Of Jilin University
Changchun, 130031
Xiangya Hospital Central-South University
Changsha, 410008
Xinqiao Hospital, 3rd Military Medical University
Chongqing, 410008
NanFang Hospital of China Southern Medical University
Guangzhou, 510515
The First Affliated Hospital of Anhui Medical University
Hefei, 230032
Qilu Hospital of Shandong University
Jinan, 250012
The Affiliated Hospital of Mecical College Qingdao University
Qingdao, 266003
Shanghai Changzhen Hospital
Shanghai, 200003
The Second Affiliated Hospital Of China Medical University
Shenyang, 110004
The First Affiliated Hospital of Suzhou University
Suzhou, 215006
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, 830001
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
Wuhan, 430000
Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430030
About this study
Official title: A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China
The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).
Read the detailed description
This registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take REVLIMID as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of REVLIMID treatment.
The registry will capture data from 600 patients being prescribed REVLIMID in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.
- Conditions
- Multiple Myeloma
- Being tested
- Revlimid (lenalidomide)
- Keywords
- Revlimid, lenalidomide, multiple myeloma, PFS, Response Rates
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revlimid (lenalidomide)Drug
Revlimid (lenalidomide) as prescribed in usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma Patients Treated with Revlimid (lenalidomide) | Single Cohort of Multiple Myeloma Patients Treated with Revlimid Receives: Drug: Revlimid (lenalidomide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Assessment of PFS using IMWG Uniform Response Criteria
Measured: 2 years after enrollment of last patient
Response Rates
Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria
Measured: 2 years after enrollment of last patient
Secondary outcomes (4)
Overall Survival (OS)
Measured: Two years after last patient enrolled
Time to Response (TTR) and Duration of Response (DOR)
Measured: Two years after last patient enrolled
Duration of Treatment with Revlimid
Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID
Measured: Two years after last patient enrolled.
Safety Profile of Revlimid
All Adverse Events (AEs) and occurrence of second primary malignancies (SPM)
Measured: Two years after last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completionSep 2016
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu (Flora) Yao, MD, Study director, Celgene Pharmaceutical (Shanghai) Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947309
- Sponsor's protocol ID
- NIPMS-RV-CN-001
- Status last verified
- Jan 2017
- First submitted
- 18 Sep 2013
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang GM, Yang GZ, Huang ZX, Zhong YP, Jin FY, Liao AJ, Wang XM, Fu ZZ, Liu H, Li XL, Zhou JF, Zhang X, Hu Y, Meng FY, Huang XJ, Chen WM, Lu J. [A prospective multi-center trial of non-interventional and observational study of lenalidomide in Chinese patients with multiple myeloma]. Zhonghua Nei Ke Za Zhi. 2017 Jul 1;56(7):500-506. doi: 10.3760/cma.j.issn.0578-1426.2017.07.006. Chinese.
PubMed 28693058
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China
- ClinicalTrials.gov ID
- NCT01947309
- Acronym / sponsor ID
- NIPMS-RV-CN-001
- Conditions
- Multiple Myeloma
- Keywords
- Revlimid, lenalidomide, multiple myeloma, PFS, Response Rates
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 176 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).
Detailed description
This registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take REVLIMID as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of REVLIMID treatment.
The registry will capture data from 600 patients being prescribed REVLIMID in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma Patients Treated with Revlimid (lenalidomide) | – | Drug: Revlimid (lenalidomide)Single Cohort of Multiple Myeloma Patients Treated with Revlimid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Chinese Patients with Multiple Myeloma Treated with Revlimid (Lenalidomide) in a Postmarketing setting
Key inclusion criteria (1 listed)
- Must understand and voluntarily sign written informed consent At least 18 years old at the time of signing informed consent Diagnosed with Multiple Myeloma Must have received at least one prior Multiple Myeloma treatment at the time of signing informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revlimid (lenalidomide)Revlimid (lenalidomide) as prescribed in usual clinical practice | Drug | Multiple Myeloma Patients Treated with Revlimid (lenalidomide) |
Primary outcome
Progression Free Survival (PFS)
Time frame: 2 years after enrollment of last patient
Assessment of PFS using IMWG Uniform Response Criteria
Response Rates
Time frame: 2 years after enrollment of last patient
Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria
4 secondary outcomes
Overall Survival (OS)
Time frame: Two years after last patient enrolled
Time to Response (TTR) and Duration of Response (DOR)
Time frame: Two years after last patient enrolled
Duration of Treatment with Revlimid
Time frame: Two years after last patient enrolled.
Safety Profile of Revlimid
Time frame: Two years after last patient enrolled
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 28693058Wang GM, Yang GZ, Huang ZX, Zhong YP, Jin FY, Liao AJ, Wang XM, Fu ZZ, Liu H, Li XL, Zhou JF, Zhang X, Hu Y, Meng FY, Huang XJ, Chen WM, Lu J. [A prospective multi-center trial of non-interventional and observational study of lenalidomide in Chinese patients with multiple myeloma]. Zhonghua Nei Ke Za Zhi. 2017 Jul 1;56(7):500-506. doi: 10.3760/cma.j.issn.0578-1426.2017.07.006. Chinese.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu (Flora) Yao, MD study director
Celgene Pharmaceutical (Shanghai) Co. Ltd.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Celgene at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 2 years after enrollment of last patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.