Multiple Myeloma
Conditions
Keywords
Multiple myeloma, Palliative care, Radiotherapy
Brief summary
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.
Interventions
RADIATIONSingle-dose involved-site radiotherapy
Single-dose of 8 Gy at involved-site radiotherapy
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy; * Age between 18 and 85 years old; * Performance on the ECOG scale less than or equal to 2. * Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same drug for at least 4 weeks before radiotherapy.
Exclusion criteria
* Refusing to sign or inability to understand the consent term; * Pain less than 2/10 on the numeric pain rating scale; * Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment; * Technical incapacity for the treatment, including, but not limited to, weight greater than 115Kg, inability to abduct the limb to be treated in appendicular bones, intolerable pain to remain in the treatment position; * Previous cancer and previous oncological treatments; * Previous autoimmune diseases, even if controlled; * Current pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retreatment rate at 6 months | 6 months after radiotherapy | Percentage of patients that needed a second corse of radiation for painful bone lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control | 6 months and 12 months | Local control by Recist 1.1 |
| Progression-free survival | 12 months | Progression-free survival |
| Overall survival | 12 months | Overall survival |
| Bone event-free survival | 6 months | by description from Raje et al. The Lancet 2018 |
| Pain relief by the numerical rating pain scale | 1, 3, 6 and 12 months | reduction on opioid and single analgesics intake and altered value in the rating pain scale |
| Pain flair incidence | 1, 3, 6 and 12 months | Enhanced pain by at least 2 levels at the numerical rating pain scale |
| Quality of life by EORCT QLQ-C30 | 1, 6 and 12 months | Quality of life by EORCT QLQ-C30 questionnaire |
| Quality of life by EORCT QLQ-C30 and MY-24 | 1, 6 and 12 months | Quality of life by EORCT MY-24 myeloma complementary questionnaires |
Countries
Brazil
Contacts
Primary ContactGeovanne P Mauro, PhD
Outcome results
None listed