Status:
COMPLETED
Retrospective and Prospective Study of POmalidomide Plus LoW Dose Dexa Efficacy in RRMM Patients Under Real-Life Conditions
Lead Sponsor:
Genesis Pharma S.A.
Conditions:
Relapse/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
The importance of real-world evidence studies stems from the following considerations. The study population of a specific clinical trial needs to meet strict inclusion and exclusion criteria, which re...
Eligibility Criteria
Inclusion
- Patients eligible for inclusion in this study have to meet all of the following criteria:
- Adult subjects (aged ≥18 years) of either gender.
- Subjects with a documented RRMM diagnosis according to IMWG or EBMT criteria prior to Pom/LoDex treatment.
- Subjects who have been initiated on Pom/LoDex treatment as per the product's Summary of Product Characteristics (SmPC) between 01 January 2016 and 28 February 2019, after having received at least two prior therapies including both lenalidomide and bortezomib and whose disease progressed after the last treatment.\*
- Note: Retrospective patients who at the time of their enrollment in the study have already completed 3 or more cycles with Pom/LoDex must have available at least one post-baseline response assessment
- Subjects with available medical files/records and detailed historical data on their disease course and clinical management.
- Provision of signed informed consent form (ICF) for collecting and analyzing medical data pertinent to the objectives of this study.\*\*
- Note: For retrospective subjects who are deceased at the date of enrollment into the study a waiver of consent will be requested by the Hospital Scientific Committee and/or Administrative Board of each participating site to either implement a hospital ICF already in place or provide written approval of this study- specific waiver. In the occasion that waiver of consent is not granted by the Scientific Committee and/or Administrative Board of the study site, deceased subjects will not be enrolled in the study.
- Exclusion Criteria:
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Prior malignancy (within the 3 years preceding initial diagnosis of MM).
- Concurrent administration of anti-cancer regimens for malignancies other than MM.
- Subjects currently participating or who have participated, during the treatment phase, in any investigational program with interventions outside of routine clinical practice.
Exclusion
Key Trial Info
Start Date :
November 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03353545
Start Date
November 16 2017
End Date
February 28 2020
Last Update
May 12 2021
Active Locations (1)
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1
Ag.Andreas General Hospital
Pátrai, Greece