Single-dose radiotherapy for painful bone lesions in multiple myeloma
Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
This study tests if a single dose of radiotherapy can help relieve pain from bone lesions in people with multiple myeloma and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT05996367 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with multiple myeloma who experience painful bone lesions. It investigates the effectiveness of a single dose of radiotherapy (8 Gy) in managing pain and describes important oncological outcomes such as retreatment rates and bone events. Additionally, the study aims to assess the quality of life and the use of analgesic medications among participants. It is a single-arm prospective cohort study, meaning all participants will receive the same treatment without a comparison group.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 with biopsy-confirmed multiple myeloma and painful bone lesions treatable with radiotherapy.
Not a fit: Patients with pain levels below 2/10 on the numeric pain rating scale or those with significant technical incapacity for treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide effective pain relief and improve the quality of life for patients suffering from painful bone lesions due to multiple myeloma.
How similar studies have performed: Previous studies have shown the effectiveness of single-dose radiotherapy for similar conditions, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- University of Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Geovanne P Mauro, PhD — University of Sao Paulo
- Study coordinator: Geovanne P Mauro, PhD
- Email: geovanne.mauro@hc.fm.usp.br
- Phone: +551126617058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.