Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
University of Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Geovanne P Mauro, PhD
geovanne.mauro@hc.fm.usp.br
+551126617058
Time Frame
Start Date: 2023-07-31
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 50
Treatments
Experimental: Single Arm
Single-dose radiation to involved-site
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo

This content was sourced from clinicaltrials.gov