Status:
RECRUITING
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05996367
Start Date
July 31 2023
End Date
July 31 2029
Last Update
August 18 2023
Active Locations (1)
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1
University of Sao Paulo
São Paulo, São Paulo, Brazil, 05403-010