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

NCT ID: NCT05996367

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2029-07-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Single-dose radiation to involved-site

Group Type: EXPERIMENTAL

Single-dose involved-site radiotherapy

Intervention Type: RADIATION

Single-dose of 8 Gy at involved-site radiotherapy

Interventions

Single-dose involved-site radiotherapy

Single-dose of 8 Gy at involved-site radiotherapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Geovanne Pedro Mauro

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geovanne P Mauro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Geovanne P Mauro, PhD

Role: CONTACT

geovanne.mauro@hc.fm.usp.br

+551126617058

Facility Contacts

Geovanne Mauro, PhD

Role: primary

geovanne.mauro@hc.fm.usp.br

+551126617058

Other Identifiers

NP 465/23

Identifier Type: -

Identifier Source: org_study_id