Actively Recruiting
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2023-08-18
50
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed plasma cell cancer with bone lesion treatable by radiotherapy
- Age between 18 and 85 years old
- Performance status on ECOG scale less than or equal to 2
- Not using systemic therapies for 4 weeks or on stable maintenance therapy with the same drug for at least 4 weeks before radiotherapy
You will not qualify if you...
- Refusal or inability to understand or sign consent form
- Pain less than 2 out of 10 on numeric pain rating scale
- Change in systemic treatment or use of bone metabolism drugs within 4 weeks before radiotherapy
- Technical inability to receive radiotherapy (weight over 115 kg, inability to position limb, intolerable pain during treatment)
- Previous cancer or prior cancer treatments
- Previous autoimmune diseases, even if controlled
- Current pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Sao Paulo
São Paulo, São Paulo, Brazil, 05403-010
Actively Recruiting
Research Team
G
Geovanne P Mauro, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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