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| ID | Type | Description | Link |
|---|---|---|---|
| MUST | Other Identifier | Alias Study Number |
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Multiple myeloma (MM) is a type of cancer of the white blood cells, called plasma cells. These plasma cells help in fighting infections.
TCR-MM is when the cancer does not get treated with the 3 main classes of medicines used to treat this disease.
The purpose of this study is to learn about the present clinical practice in Italy and describe the standard of care that will be given to patients with TCR-MM, and their treatment costs, in around 25 centers who treat patients with blood diseases.
Standard of care (SoC) is the treatment that is accepted as a proper treatment for a certain type of disease and that is widely used by doctors.
The study is seeking for participants who are:
The main data source for the study will be the patient medical record. No clinical visits, examinations, or procedures are required as part of this study.
In Italy, MM represents 1.6 percent of all cancers diagnosed in men and 1.5 percent of those diagnosed in women. The 2020 Italian epidemiological data show 5759 new diagnosis of MM. Most MM patients relapse or become refractory to various therapeutic approaches and typically cycle through many lines of treatment. Survival among patients refractory to newer therapies, including PIs, IMiDs and anti-CD38 mAbs, is very low and measured in months. An Italian real life data collection is important to analyse the current therapeutic approaches in TCR patients and the costs incurred by the therapy based on the different treatments.
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| Measure | Description | Time Frame |
|---|---|---|
| Real-World Overall Response Rate (ORR) for each TCR MM therapy | The proportion of patients with confirmed Stringent Complete Response (sCR), Complete Response (CR), Very good partial response (VGPR), Partial Response (PR) by investigators per the International Myeloma Working Group (IMWG) criteria | 3-18 months |
| Real-World Progression Free Survival (PFS) | The time from initiation of therapy until Progressive Disease (PD) by investigators per IMWG criteria or death due to any cause, whichever occurs first. | 3-18 months |
| Real-World Overall Survival (OS) | Time from initiation of therapy until death due to any cause. | 3-18 months |
| Real-World Duration of response (DOR) | For participants with an objective response (OR) per IMWG criteria, as the time from the first documentation of OR by investigators that is subsequently confirmed, until PD per IMWG criteria, or death due to any cause, whichever occurs first. | 3-18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients must have evidence of the following criteria in their medical records at the date of first dose of first treatment after TCR MM eligibility to be included in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. - Ospedali Riuniti di Ancona | Torrette | Aviano | 60126 | Italy | ||
| A.O.U. Policlinico S.Orsola Malpighi |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Bologna |
| BO |
| 40138 |
| Italy |
| "IRCCS "" Casa Sollievo della Sofferenza""tOpera di San Pio da Pietrelcina U.O.C di Ematologia" | San Giovanni Rotondo | Foggia | 71013 | Italy |
| AOU Policlinico Umberto I | Rome | Lazio | 00161 | Italy |
| Fondazione IRCCS Policlinico Sa Matteo U.O.C. Ematologia | Pavia | Lombardy | 27100 | Italy |
| A.O.U Policlinico G. Rodolico S. Marco | Catania | Sicily | 95123 | Italy |
| A.O.U. Policlinico Paolo Giaccone | Palermo | Sicily | 90129 | Italy |
| A.O.O.R. Villa Sofia Cervello, U.O. Oncoematologia | Palermo | Sicily | 90146 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Clinica di Oncologia Medica Policlinico San Martino | Genova | 16132 | Italy |
| IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola (FC) | 47014 | Italy |
| A.O.U. Policlinico Università degli Studi di Napoli "Federico II" | Naples | 80131 | Italy |
| Azienda Ospedaliero-Universitaria Maggiore della Carita | Novara | 28100 | Italy |
| Azienda Ospedaliero - Universitaria Di Parma | Parma | 43126 | Italy |
| Ospedale Civile dello Spirito Santo | Pescara | 65124 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia | Rimini | 47923 | Italy |
| Irccs Crob | Rionero in Vulture | 85028 | Italy |
| San Giovanni Di Dio E Ruggi D'Aragona Hospital | Salerno | 84131 | Italy |
| Busto Arsizio Hospital | Varese | 21052 | Italy |
| 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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