Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-dose involved-site radiotherapy.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
Overview
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
- Radiation Single-dose involved-site radiotherapy
Single-dose of 8 Gy at involved-site radiotherapy
Primary outcome measures
- Retreatment rate at 6 months [Time frame: 6 months after radiotherapy]
Secondary outcome measures (8)
- Local control [Time frame: 6 months and 12 months]
- Progression-free survival [Time frame: 12 months]
- Overall survival [Time frame: 12 months]
- Bone event-free survival [Time frame: 6 months]
- Pain relief by the numerical rating pain scale [Time frame: 1, 3, 6 and 12 months]
- Pain flair incidence [Time frame: 1, 3, 6 and 12 months]
- Quality of life by EORCT QLQ-C30 [Time frame: 1, 6 and 12 months]
- Quality of life by EORCT QLQ-C30 and MY-24 [Time frame: 1, 6 and 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- University of Sao Paulo — São Paulo
Identifiers
NCT: NCT05996367 · NP 465/23