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Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In 2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without description of several important oncological outcomes. This is a single-arm prospective cohort study. This study aims to describe these outcomes, including retreatment rate and bone events. Also, as secondary objectives, describe the quality of life and use of analgesic medications in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Single-dose radiation to involved-site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-dose involved-site radiotherapy | Radiation | Single-dose of 8 Gy at involved-site radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retreatment rate at 6 months | Percentage of patients that needed a second corse of radiation for painful bone lesions | 6 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Local control | Local control by Recist 1.1 | 6 months and 12 months |
| Progression-free survival | Progression-free survival | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geovanne P Mauro, PhD | Contact | +551126617058 | geovanne.mauro@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Geovanne P Mauro, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | Recruiting | São Paulo | São Paulo | 05403-010 | Brazil |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Overall survival | Overall survival | 12 months |
| Bone event-free survival | by description from Raje et al. The Lancet 2018 | 6 months |
| Pain relief by the numerical rating pain scale | reduction on opioid and single analgesics intake and altered value in the rating pain scale | 1, 3, 6 and 12 months |
| Pain flair incidence | Enhanced pain by at least 2 levels at the numerical rating pain scale | 1, 3, 6 and 12 months |
| Quality of life by EORCT QLQ-C30 | Quality of life by EORCT QLQ-C30 questionnaire | 1, 6 and 12 months |
| Quality of life by EORCT QLQ-C30 and MY-24 | Quality of life by EORCT MY-24 myeloma complementary questionnaires | 1, 6 and 12 months |
| 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 |