Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma
PrObe-L
Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma
1 other identifier
observational
22
1 country
12
Brief 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 Characteristics (SmPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2016
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2016
CompletedStudy Start
First participant enrolled
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2018
CompletedJune 30, 2022
June 1, 2022
2.8 years
February 22, 2016
June 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to approximately 72 months
Secondary Outcomes (4)
Incidence (number) of thromboembolism
Up to approximately 72 months
Duration of Len/Dex treatment over the course of the study
Up to approximately 72 months
Number of patients with good and poor compliance to lenalidomide and dexamethasone
Up to approximately 72 months
Type and frequency of prophylaxis treatment for prevention of thromboembolism
Up to 36 months
Study Arms (1)
Lenalidomide/Dexamethasone
Standard of Care doses for relapsed/refractory multiple myeloma
Interventions
Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle
Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
Eligibility Criteria
Relapsed and/or Refractory multiple myeloma patient population
You may qualify if:
- 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) -
You may not qualify if:
- 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.
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (12)
Hospital Garcia Orta, E.P.E.
Almada, 2805-267 Almada, Portugal
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora, 2720-276 Amadora, Portugal
Hospital Central de Faro
Faro, 8000-386 Faro, Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, 1099-023 Lisboa, Portugal
Centro Hospitalar Lisboa Central, EPE - Hospital de Sto. Ant. Capuchos
Lisbon, 1169-050 Lisboa, Portugal
Fundação Champalimaud
Lisbon, 1400-038 Lisboa, Portugal
Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-035 Lisboa, Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001 Porto, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072 Porto, Portugal
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, 4200-319 Porto, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4430-502 Vila Nova de Gaia, Portugal
Hospital de São Teotónio, E.P.E.
Viseu, 3504-509 Viseu, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabel Boaventura, MD
Celgene
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
February 26, 2016
Study Start
February 25, 2016
Primary Completion
December 12, 2018
Study Completion
December 12, 2018
Last Updated
June 30, 2022
Record last verified: 2022-06