Multiple MyelomaPrObe-LNCT02692339
Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma
An observational study of Multiple Myeloma, run by Celgene at 12 sites in Portugal.
Trial summary
Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product… 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?
- Lenalidomide and Dexamethasone
- How many people
- 22 participants
- Where
- 12 sitesPortugal
- Study dates
- 25 Feb 2016to 12 Dec 2018
- How long will I take part?
- 36 Months
- 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: Relapsed and/or Refractory multiple myeloma patient population
Who may be able to join
- Patients aged 18 years or higher.
- Patients who have voluntarily given written informed consent to participate in the study and have their data retrieved for the purposes of the study
- Patients diagnosed with 1st or 2nd relapsed or refractory multiple myeloma and indicated for 2nd or 3rd line Len/Dex treatment, according with the SmPC (patients who have received at least one prior therapy) -
Who cannot join
- Pregnant or lactating patients
- Female patients of childbearing potential unable or unwilling to use effective contraceptive methods, as stated in the summary of product characteristics:
- Implant.
- Levonorgestrel-releasing intrauterine system.
- Medroxyprogesterone acetate depot.
- Tubal sterilisation.
Show all 11Show fewer
- Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses.
- Ovulation inhibitory progesterone-only pills (i.e. desogestrel).
- Male patients unable to follow or comply with the required contraceptive measures stated in the SmPC (use of condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception [even if the man has had a vasectomy], during treatment and for 1 week after dose interruptions and/or cessation of treatment)
- Hypersensitivity to the active substance or any of the excipients
- Patients participating in a clinical trial -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Portugal12 sites
Hospital Garcia Orta, E.P.E.
Almada, 2805-267 Almada
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora, 2720-276 Amadora
Hospital Central de Faro
Faro, 8000-386 Faro
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, 1099-023 Lisboa
Centro Hospitalar Lisboa Central, EPE - Hospital de Sto. Ant. Capuchos
Lisbon, 1169-050 Lisboa
Fundação Champalimaud
Lisbon, 1400-038 Lisboa
Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-035 Lisboa
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001 Porto
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072 Porto
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, 4200-319 Porto
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4430-502 Vila Nova de Gaia
Hospital de São Teotónio, E.P.E.
Viseu, 3504-509 Viseu
About this study
Official title: Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma
Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product Characteristics (SmPC).
Read the detailed description
This study aims to assess the real-life safety of Lenalidomide/Dexamethasone (Len/Dex) in patients with (Relapsed or Refractory Multiple Myeloma (rrMM), by evaluation of adverse events of special interest (infections, gastrointestinal events, thrombocytopenia, neutropenia, febrile neutropenia, and thromboembolism). In addition, due to the scarce information regarding the impact of frailty in Len/Dex treatment in rrMM, this study will prospectively assess Len/Dex safety and effectiveness by patient frailty groups.
The following study assessments will be performed:
- Recruitment: patients will be recruited within 15 days after the start of Len/Dex (from day 1 to day 15). In case patients are not recruited at the day of Len/Dex start (day 1), baseline information respective to this day will be collected retrospectively.
- Treatment period: during this period, the following assessments will be carried out:
- Every 30 days (± 5 days) for adverse events, changes in concomitant medication and change in Len/Dex dose.
- Every 90 days (± 15 days) for the remaining information to be collected in the treatment period
- Assessment at the end of Len/Dex treatment (until 5 days after end of treatment).
Follow-up assessment 90 days (± 15 days) after the end of Len/Dex treatment.
No visits were predefined for this study. Study data is planned to be collected when the patient goes to the study site for a clinical routine visit. No assessments will be imposed for the purposes of this study. If the patient goes to the clinical routine visit at a date out of the time intervals predicted above, no information will be collected. Information will be collected in the context of routine clinical practice.
The patient will be followed until the end of Len/Dex treatment, death or discontinuation for any reason for a maximum period of 36 months, Patients within treatment after this maximum period will stop being followed in the study.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide, Dexamethasone
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Lenalidomide, Dexamethasone, Observational Study, Safety of Len/Dex
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle
DexamethasoneDrug
Also called Decadron
Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide/Dexamethasone | Standard of Care doses for relapsed/refractory multiple myeloma Receives: Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events of special interest during Len/Dex therapy
Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, i.e. any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Progression of the underlying disease of multiple myeloma is not considered an AE and should not be reported as an AE
Measured: Up to approximately 72 months
Secondary outcomes (4)
Incidence (number) of thromboembolism
Identification of the incidence of deep venous thrombosis and pulmonary embolism) during Lenalidomide and Dexamethasone study drug treatment.
Measured: Up to approximately 72 months
Duration of Len/Dex treatment over the course of the study
Defined as the time between the start of Len/Dex treatment until discontinuation or death (whichever occurs first)
Measured: Up to approximately 72 months
Number of patients with good and poor compliance to lenalidomide and dexamethasone
Compliance will be measured by the capsule/tablet count, after the end of study treatment
Measured: Up to approximately 72 months
Type and frequency of prophylaxis treatment for prevention of thromboembolism
Type and frequency of prophylaxis treatment for prevention of thromboembolism during Lenalidomide/Dexamethasone study treatment.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start25 Feb 2016
- Primary completion12 Dec 2018
- Study completion12 Dec 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
- 22 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabel Boaventura, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692339
- Sponsor's protocol ID
- CC-5013-MM-028
- Acronym
- PrObe-L
- Status last verified
- Jun 2022
- First submitted
- 22 Feb 2016
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02692339
- Acronym / sponsor ID
- PrObe-L / CC-5013-MM-028
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Lenalidomide, Dexamethasone, Observational Study, Safety of Len/Dex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 26 Feb 2016 (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.
Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product Characteristics (SmPC).
Detailed description
This study aims to assess the real-life safety of Lenalidomide/Dexamethasone (Len/Dex) in patients with (Relapsed or Refractory Multiple Myeloma (rrMM), by evaluation of adverse events of special interest (infections, gastrointestinal events, thrombocytopenia, neutropenia, febrile neutropenia, and thromboembolism). In addition, due to the scarce information regarding the impact of frailty in Len/Dex treatment in rrMM, this study will prospectively assess Len/Dex safety and effectiveness by patient frailty groups.
The following study assessments will be performed:
- Recruitment: patients will be recruited within 15 days after the start of Len/Dex (from day 1 to day 15). In case patients are not recruited at the day of Len/Dex start (day 1), baseline information respective to this day will be collected retrospectively.
- Treatment period: during this period, the following assessments will be carried out:
- Every 30 days (± 5 days) for adverse events, changes in concomitant medication and change in Len/Dex dose.
- Every 90 days (± 15 days) for the remaining information to be collected in the treatment period
- Assessment at the end of Len/Dex treatment (until 5 days after end of treatment).
Follow-up assessment 90 days (± 15 days) after the end of Len/Dex treatment.
No visits were predefined for this study. Study data is planned to be collected when the patient goes to the study site for a clinical routine visit. No assessments will be imposed for the purposes of this study. If the patient goes to the clinical routine visit at a date out of the time intervals predicted above, no information will be collected. Information will be collected in the context of routine clinical practice.
The patient will be followed until the end of Len/Dex treatment, death or discontinuation for any reason for a maximum period of 36 months, Patients within treatment after this maximum period will stop being followed in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide/Dexamethasone | – | Drug: Lenalidomide, Drug: DexamethasoneStandard of Care doses for relapsed/refractory multiple myeloma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsed and/or Refractory multiple myeloma patient population
Key inclusion criteria (3 listed)
- Patients aged 18 years or higher.
- Patients who have voluntarily given written informed consent to participate in the study and have their data retrieved for the purposes of the study
- Patients diagnosed with 1st or 2nd relapsed or refractory multiple myeloma and indicated for 2nd or 3rd line Len/Dex treatment, according with the SmPC (patients who have received at least one prior therapy) -
Key exclusion criteria (11 listed)
- Pregnant or lactating patients
- Female patients of childbearing potential unable or unwilling to use effective contraceptive methods, as stated in the summary of product characteristics:
- Ovulation inhibitory progesterone-only pills (i.e. desogestrel).
- Hypersensitivity to the active substance or any of the excipients
- Patients participating in a clinical trial -
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 |
|---|---|---|
| LenalidomideAlso: RevlimidStandard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle | Drug | Lenalidomide/Dexamethasone |
| DexamethasoneAlso: DecadronStandard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle | Drug | Lenalidomide/Dexamethasone |
Primary outcome
Number of Adverse events of special interest during Len/Dex therapy
Time frame: Up to approximately 72 months
Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, i.e. any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Progression of the underlying disease of multiple myeloma is not considered an AE and should not be reported as an AE
4 secondary outcomes
Incidence (number) of thromboembolism
Time frame: Up to approximately 72 months
Duration of Len/Dex treatment over the course of the study
Time frame: Up to approximately 72 months
Number of patients with good and poor compliance to lenalidomide and dexamethasone
Time frame: Up to approximately 72 months
Type and frequency of prophylaxis treatment for prevention of thromboembolism
Time frame: Up to 36 months
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 30 Jun 2022.
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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.
Isabel Boaventura, MD study director
Celgene
12 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 12 sites in Portugal.
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 11 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Portugal. 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?
Number of Adverse events of special interest during Len/Dex therapy (time frame: Up to approximately 72 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 30 Jun 2022.