Multiple Myeloma
Conditions
Keywords
Revlimid, lenalidomide, multiple myeloma, PFS, Response Rates
Brief summary
The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).
Detailed description
This registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take REVLIMID as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of REVLIMID treatment. The registry will capture data from 600 patients being prescribed REVLIMID in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.
Interventions
Revlimid (lenalidomide) as prescribed in usual clinical practice
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must understand and voluntarily sign written informed consent At least 18 years old at the time of signing informed consent Diagnosed with Multiple Myeloma Must have received at least one prior Multiple Myeloma treatment at the time of signing informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 2 years after enrollment of last patient | Assessment of PFS using IMWG Uniform Response Criteria |
| Response Rates | 2 years after enrollment of last patient | Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Two years after last patient enrolled | — |
| Time to Response (TTR) and Duration of Response (DOR) | Two years after last patient enrolled | — |
| Duration of Treatment with Revlimid | Two years after last patient enrolled. | Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID |
| Safety Profile of Revlimid | Two years after last patient enrolled | All Adverse Events (AEs) and occurrence of second primary malignancies (SPM) |
Countries
China
Outcome results
None listed