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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Single-dose of 8 Gy at involved-site radiotherapy
University of Sao Paulo
São Paulo, São Paulo, Brazil
RECRUITINGRetreatment rate at 6 months
Percentage of patients that needed a second corse of radiation for painful bone lesions
Time frame: 6 months after radiotherapy
Local control
Local control by Recist 1.1
Time frame: 6 months and 12 months
Progression-free survival
Progression-free survival
Time frame: 12 months
Overall survival
Overall survival
Time frame: 12 months
Bone event-free survival
by description from Raje et al. The Lancet 2018
Time frame: 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
Time frame: 1, 3, 6 and 12 months
Pain flair incidence
Enhanced pain by at least 2 levels at the numerical rating pain scale
Time frame: 1, 3, 6 and 12 months
Quality of life by EORCT QLQ-C30
Quality of life by EORCT QLQ-C30 questionnaire
Time frame: 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
Time frame: 1, 6 and 12 months
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