A Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma in Spain

Study Overview
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Brief Summary
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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.

Official Title
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Retrospective Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma Between 2012 and 2016, Treated According to Routine Clinical Practice in Spain

Conditions
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Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with newly diagnosed transplant-ineligible MM<br>Adult Patients with newly diagnosed MM who were not suitable candidates for ASCT who started first-line treatment for the study disease in a routine clinical practice setting between 2012 and 2016, inclusive. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the first-line treatment regimens | 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) | Up to approximately 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain | 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 | Up to approximately 5 months | 
| Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain | Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each MM subtype group | Up to approximately 5 months | 
| Progression-free survival (PFS) | Is described as time from start of treatment until disease progression or death | Up to approximately 5 months | 
| Overall survival (OS) | Is described as time from start of the treatment until death | Up to approximately 5 months | 
| Overall response rate | Is based on IMWG criteria | Up to approximately 5 months | 
| Duration of response | Is described as time from start of the treatment until end of first line treatment | Up to approximately 5 months | 
| Patients who receive second-line treatment | Proportion of patients who receive second-line treatment | Up to approximately 5 months | 
| Patients who underwent dose adjustment or switched treatment | Proportion of patients who underwent dose adjustment or switched treatment | Up to approximately 5 months | 
| Patients who discontinued treatment | Proportion of patients who discontinued treatment | Up to approximately 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant, Multiple Myeloma, Spain