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Trial Title:
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
NCT ID:
NCT05996367
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple myeloma
Palliative care
Radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Single-dose involved-site radiotherapy
Description:
Single-dose of 8 Gy at involved-site radiotherapy
Arm group label:
Single Arm
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 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Sao Paulo
Address:
City:
São Paulo
Zip:
05403-010
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Geovanne Mauro, PhD
Phone:
+551126617058
Email:
geovanne.mauro@hc.fm.usp.br
Start date:
July 31, 2023
Completion date:
July 31, 2029
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996367
