Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma

Not Applicable

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Radiation: Single-dose involved-site radiotherapy

• Registration Number: NCT05996367
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-31
• Study First Submitted: 2023-07-31
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Primary Completion: 2028-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Single-dose involved-site radiotherapy	Single-dose radiation to involved-site

Primary Outcome Measures

Name	Time	Method
Retreatment rate at 6 months	6 months after radiotherapy	Percentage of patients that needed a second corse of radiation for painful bone lesions

Secondary Outcome Measures

Name	Time	Method
Pain flair incidence	1, 3, 6 and 12 months	Enhanced pain by at least 2 levels at the numerical rating pain scale
Pain relief by the numerical rating pain scale	1, 3, 6 and 12 months	reduction on opioid and single analgesics intake and altered value in the rating pain scale
Overall survival	12 months	Overall survival
Local control	6 months and 12 months	Local control by Recist 1.1
Progression-free survival	12 months	Progression-free survival
Bone event-free survival	6 months	by description from Raje et al. The Lancet 2018
Quality of life by EORCT QLQ-C30	1, 6 and 12 months	Quality of life by EORCT QLQ-C30 questionnaire
Quality of life by EORCT QLQ-C30 and MY-24	1, 6 and 12 months	Quality of life by EORCT MY-24 myeloma complementary questionnaires

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil