Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma (PrObe-L)
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|ClinicalTrials.gov Identifier: NCT02692339|
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: Lenalidomide Drug: Dexamethasone|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||36 Months|
|Official Title:||Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||February 25, 2016|
|Estimated Primary Completion Date :||September 29, 2023|
|Estimated Study Completion Date :||September 29, 2023|
Standard of Care doses for relapsed/refractory multiple myeloma
Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle
Other Name: Revlimid
Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
Other Name: Decadron
- 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
- Incidence (number) of thromboembolism [ Time Frame: Up to approximately 72 months ]Identification of the incidence of deep venous thrombosis and pulmonary embolism) during Lenalidomide and Dexamethasone study drug treatment.
- Duration of Len/Dex treatment over the course of the study [ Time Frame: Up to approximately 72 months ]Defined as the time between the start of Len/Dex treatment until discontinuation or death (whichever occurs first)
- Number of patients with good and poor compliance to lenalidomide and dexamethasone [ Time Frame: Up to approximately 72 months ]Compliance will be measured by the capsule/tablet count, after the end of study treatment
- Type and frequency of prophylaxis treatment for prevention of thromboembolism [ Time Frame: Up to 36 months ]Type and frequency of prophylaxis treatment for prevention of thromboembolism during Lenalidomide/Dexamethasone study treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692339
|Contact: Sara Vieiraemail@example.com|
|Hospital Garcia Orta, E.P.E.||Not yet recruiting|
|Almada, Portugal, 2805-267 Almada|
|Hospital Professor Doutor Fernando Fonseca, E.P.E.||Not yet recruiting|
|Amadora, Portugal, 2720-276 Amadora|
|Hospital Central de Faro||Not yet recruiting|
|Faro, Portugal, 8000-386 Faro|
|Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE||Not yet recruiting|
|Lisboa, Portugal, 1099-023 Lisboa|
|Centro Hospitalar Lisboa Central, EPE - Hospital de Sto. Ant. Capuchos||Not yet recruiting|
|Lisboa, Portugal, 1169-050 Lisboa|
|Lisboa, Portugal, 1400-038 Lisboa|
|Centro Hospitalar Lisboa Norte, EPE - Hospital Santa Maria||Recruiting|
|Lisboa, Portugal, 1649-035 Lisboa|
|Centro Hospitalar do Porto - Hospital de Santo António||Recruiting|
|Porto, Portugal, 4099-001 Porto|
|Instituto Português de Oncologia do Porto Francisco Gentil, EPE||Not yet recruiting|
|Porto, Portugal, 4200-072 Porto|
|Centro Hospitalar de São João, EPE - Hospital de São João||Recruiting|
|Porto, Portugal, 4200-319 Porto|
|Centro Hospitalar de Vila Nova de Gaia||Not yet recruiting|
|Vila Nova de Gaia, Portugal, 4430-502 Vila Nova de Gaia|
|Hospital de São Teotónio, E.P.E.||Not yet recruiting|
|Viseu, Portugal, 3504-509 Viseu|
|Study Director:||Isabel Boaventura, MD||Celgene|