Multiple Myeloma
Conditions
Keywords
Transplant, Multiple Myeloma, Spain
Brief summary
This is an observational, post-authorization, retrospective, multicenter study (PAS-OD) that will be conducted in approximately 20 centers in Spain. In all cases, only data recorded prior to the date of study start will be collected to ensure its retrospective nature, thus reflecting real clinical practice, avoiding any influence on the physician's clinical practice.
Interventions
None listed
Sponsors
Celgene
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 18 years * Patients with newly diagnosed MM who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive. * Patients who give informed consent before data collection begins.
Exclusion criteria
* Patients who participated in a clinical trial for first-line treatment of MM during the study period. * Patients who are alive, but do not give their IC. * Patients with MM who did not receive treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of the first-line treatment regimens | Up to approximately 5 months | Number of patients in the different first-line treatment regimens, in terms of the main drug used in patients diagnosed de novo with MM who were not candidates for autologous stem cell transplantation (ASCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients who underwent dose adjustment or switched treatment | Up to approximately 5 months | Proportion of patients who underwent dose adjustment or switched treatment |
| Patients who discontinued treatment | Up to approximately 5 months | Proportion of patients who discontinued treatment |
| Progression-free survival (PFS) | Up to approximately 5 months | Is described as time from start of treatment until disease progression or death |
| Patients who receive second-line treatment | Up to approximately 5 months | Proportion of patients who receive second-line treatment |
| Overall response rate | Up to approximately 5 months | Is based on IMWG criteria |
| Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain | Up to approximately 5 months | Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each staging group: Stage I, II and III (ISS) and ISS R |
| Duration of response | Up to approximately 5 months | Is described as time from start of the treatment until end of first line treatment |
| Overall survival (OS) | Up to approximately 5 months | Is described as time from start of the treatment until death |
Countries
Spain
Outcome results
None listed