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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996367
• Other study ID #: NP 465/23
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: July 31, 2029

Study information

• Verified date: August 2023
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Geovanne P Mauro, PhD
• Phone: +551126617058
• Email: geovanne.mauro[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2029
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Radiation:
• Single-dose involved-site radiotherapy
Single-dose of 8 Gy at involved-site radiotherapy

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retreatment rate at 6 months	Percentage of patients that needed a second corse of radiation for painful bone lesions	6 months after radiotherapy
Secondary	Local control	Local control by Recist 1.1	6 months and 12 months
Secondary	Progression-free survival	Progression-free survival	12 months
Secondary	Overall survival	Overall survival	12 months
Secondary	Bone event-free survival	by description from Raje et al. The Lancet 2018	6 months
Secondary	Pain relief by the numerical rating pain scale	reduction on opioid and single analgesics intake and altered value in the rating pain scale	1, 3, 6 and 12 months
Secondary	Pain flair incidence	Enhanced pain by at least 2 levels at the numerical rating pain scale	1, 3, 6 and 12 months
Secondary	Quality of life by EORCT QLQ-C30	Quality of life by EORCT QLQ-C30 questionnaire	1, 6 and 12 months
Secondary	Quality of life by EORCT QLQ-C30 and MY-24	Quality of life by EORCT MY-24 myeloma complementary questionnaires	1, 6 and 12 months