NCT05996367Recruiting
Prospective Cohort of 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
Source: ClinicalTrials.gov · Last updated 18 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 31 Jul 2023
- Start date
- 31 Jul 2023
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Diseases
- Multiple myeloma
- NCT number
- NCT05996367
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 31 Jul 2023 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment;
- Previous autoimmune diseases, even if controlled;
Other illness
- Previous cancer and previous oncological treatments;
Other
- Refusing to sign or inability to understand the consent term;
- Pain less than 2/10 on the numeric pain rating scale;
- 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;
- Current pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.