Relapsed/Refractory Multiple MyelomaLEGENDNCT02608515
A Retrospective Chart Review Study of the Outcomes of 2nd Line Therapy With LEn/Dex in Greek Patients With R/R Multiple MyEloma and the Treatment PatterNs Following Progressive Disease
An observational study of Relapsed/Refractory Multiple Myeloma, run by Genesis Pharma S.A. at 1 site in Greece.
Trial summary
This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- How many people
- 207 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2015to 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: A total of approximately 220 patients with RRMM that started second-line treatment with lenalidomide/dexamethasone between 01 January 2009 to 01 March 2014 and who fulfill all study-specific eligibility criteria at the investigators' discretion will be included in this study
Who may be able to join
- Subjects must fulfill ALL of the following criteria:
- Subjects of both genders, aged 18 years or older
- Subjects must have a relapsed or refractory MM diagnosis according to IMWG or EBMT criteria
- Subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' Summary of Product Characteristics (SmPC) between 01 January 2009 and 01 March 2014
- Subjects must have available medical files/records and detailed historical data on their disease course and clinical management
- Provision of signed ICF for collecting and analyzing medical data pertinent to the objectives of this study
Who cannot join
- For the candidate subjects NONE of the following criteria should apply:
- Prior malignancy (within the 3 years preceding initial diagnosis of MM)
- Concurrent administration of anti-cancer regimens for malignancies other than MM between the time of initial MM diagnosis and time of second relapse
- Subject participation in an interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Chart Review Study of the Outcomes of Second Line Therapy With LEnalidomide/Dexamethasone in Greek Patients With Relapsed/Refractory Multiple MyEloma and the Treatment PatterNs Following Progressive Disease, "The LEGEND Study"
This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse
PFS rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kiki Karvounis, Study director, Medical Department of Genesis Pharma SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608515
- Sponsor's protocol ID
- NIPMS-GENESIS-MM-GRC-002
- Acronym
- LEGEND
- Status last verified
- May 2018
- First submitted
- 17 Nov 2015
- Last updated
- 22 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review Study of the Outcomes of Second Line Therapy With LEnalidomide/Dexamethasone in Greek Patients With Relapsed/Refractory Multiple MyEloma and the Treatment PatterNs Following Progressive Disease, "The LEGEND Study"
- ClinicalTrials.gov ID
- NCT02608515
- Acronym / sponsor ID
- LEGEND / NIPMS-GENESIS-MM-GRC-002
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Genesis Pharma S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Nov 2015 (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.
This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of approximately 220 patients with RRMM that started second-line treatment with lenalidomide/dexamethasone between 01 January 2009 to 01 March 2014 and who fulfill all study-specific eligibility criteria at the investigators' discretion will be included in this study
Key inclusion criteria (6 listed)
- Subjects of both genders, aged 18 years or older
- Subjects must have a relapsed or refractory MM diagnosis according to IMWG or EBMT criteria
- Subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' Summary of Product Characteristics (SmPC) between 01 January 2009 and 01 March 2014
- Subjects must have available medical files/records and detailed historical data on their disease course and clinical management
- Provision of signed ICF for collecting and analyzing medical data pertinent to the objectives of this study
Key exclusion criteria (4 listed)
- Prior malignancy (within the 3 years preceding initial diagnosis of MM)
- Concurrent administration of anti-cancer regimens for malignancies other than MM between the time of initial MM diagnosis and time of second relapse
- Subject participation in an interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse
Time frame: 12 months
PFS rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Published ManuscriptLink provided by the sponsor.
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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.
Kiki Karvounis study director
Medical Department of Genesis Pharma SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Multiple Myeloma, run by Genesis Pharma S.A. at 1 site in Greece.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2018.