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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1215-4398 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with newly diagnosed transplant-ineligible MM | 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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In total, 400 patients with a de novo diagnosis of multiple myeloma who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive, in a routine clinical practice setting in Spain, will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Giselle Lostaunau, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Santiago (CHUS) | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| H. Txagorritxu |
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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 |
| Vitoria-Gasteiz |
| Alava |
| 01009 |
| Spain |
| H. Son Espases | Palma | Balearic Islands | 07120 | Spain |
| ICO Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| H. Althaia | Manresa | Barcelona | 08243 | Spain |
| H. Mutua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| H. Jerez | Jerez de la Frontera | Cadiz | 11408 | Spain |
| H. Alvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| H. Cabueñes | Gijón | Principality of Asturias | 33394 | Spain |
| H. Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| H. del Mar | Barcelona | 0 8003 | Spain |
| H. Josep Trueta | Girona | 17007 | Spain |
| H. Arnau de Villanova | Lleida | 25198 | Spain |
| H- Virgen de la Victoria | Málaga | 29010 | Spain |
| H. Carlos Haya | Málaga | 29010 | Spain |
| H. Ourense (CHOU) | Ourense | 32005 | Spain |
| H. Virgen Macarena | Seville | 41009 | Spain |
| H. Joan XXIII | Tarragona | 43005 | Spain |
| H. Dr. Peset | Valencia | 46017 | Spain |
| H. La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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