Multiple MyelomaREVIEWNCT02528838
An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.
An observational study of Multiple Myeloma, run by Celgene.
Trial summary
The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2011to 15 Jan 2018
- 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: Patients already successfully, i.e. with currently stable disease or meeting the criteria for complete response, very good partial response or partial response, on-treatment for maximally up to 6 cycles with lenalidomide at each site will be enrolled into the study. In all cases, the decision to treat the patient with lenalidomide was already made prior to the decision to enter the subject into the study.
Who may be able to join
- Patients over 18 years of age who understand and voluntarily sign an informed consent form.
- Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for > 2 cycles and < 6 cycles.
- Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment.
Who cannot join
- Refusal to participate in the study.
- Women who are pregnant or breast-feeding.
- Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
- Hypersensitivity to the active substance or to any of the excipients.
About this study
Official title: A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)
The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Non-interventional, Observational, Lenalidomide, REVIEW, Post-authorization, Netherlands
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Revlimid according to clinical practice | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE)
Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible
Measured: Up to approximatly 4 years
Secondary outcomes (5)
Quality of Life
Quality of life will be measured by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QL Q-C30) and EORTC QLQ-MY20
Measured: Up to approximatly 24 months
Lenalidomide usage patterns
Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice
Measured: Up to approximatly 4 years
Lenalodomide dose modifications
Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice
Measured: Up to approximatly 4 years
Reasons for discontinuation of lenalidomide
Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice
Measured: Up to approximatly 4 years
Clinical outcome
Clinical outcome will be measured using routine assessment criteria (i.e. IMWG)
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start1 May 2011
- Primary completion30 Jun 2016
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeroen Stevens, MSc, Study director, Celgene BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528838
- Sponsor's protocol ID
- NIPMS-Celgene-NETH-001
- Acronym
- REVIEW
- Status last verified
- May 2020
- First submitted
- 6 Aug 2015
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)
- ClinicalTrials.gov ID
- NCT02528838
- Acronym / sponsor ID
- REVIEW / NIPMS-Celgene-NETH-001
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Non-interventional, Observational, Lenalidomide, REVIEW, Post-authorization, Netherlands
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 May 2011 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 19 Aug 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.
The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Revlimid according to clinical practice | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already successfully, i.e. with currently stable disease or meeting the criteria for complete response, very good partial response or partial response, on-treatment for maximally up to 6 cycles with lenalidomide at each site will be enrolled into the study. In all cases, the decision to treat the patient with lenalidomide was already made prior to the decision to enter the subject into the study.
Key inclusion criteria (3 listed)
- Patients over 18 years of age who understand and voluntarily sign an informed consent form.
- Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for > 2 cycles and < 6 cycles.
- Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment.
Key exclusion criteria (4 listed)
- Refusal to participate in the study.
- Women who are pregnant or breast-feeding.
- Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
- Hypersensitivity to the active substance or to any of the excipients.
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
Adverse Event (AE)
Time frame: Up to approximatly 4 years
Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible
5 secondary outcomes
Quality of Life
Time frame: Up to approximatly 24 months
Lenalidomide usage patterns
Time frame: Up to approximatly 4 years
Lenalodomide dose modifications
Time frame: Up to approximatly 4 years
Reasons for discontinuation of lenalidomide
Time frame: Up to approximatly 4 years
Clinical outcome
Time frame: Up to approximately 4 years
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 27 May 2020.
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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.
Jeroen Stevens, MSc study director
Celgene BV
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Celgene.
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 3 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Adverse Event (AE) (time frame: Up to approximatly 4 years). 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 27 May 2020.