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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Radiation: Single-dose involved-site radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geovanne P Mauro, PhD; Phone Number: +551126617058; Email: geovanne.mauro@hc.fm.usp.br

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403-010
      • Recruiting
      • University of Sao Paulo
      • Contact: Geovanne Mauro, PhD; Phone Number: +551126617058; Email: geovanne.mauro@hc.fm.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Single-dose radiation to involved-site	Radiation: Single-dose involved-site radiotherapy; Single-dose of 8 Gy at involved-site radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retreatment rate at 6 months	Percentage of patients that needed a second corse of radiation for painful bone lesions	6 months after radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	12 months
Local control	Local control by Recist 1.1	6 months and 12 months
Progression-free survival	Progression-free survival	12 months
Bone event-free survival	by description from Raje et al. The Lancet 2018	6 months
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
Pain flair incidence	Enhanced pain by at least 2 levels at the numerical rating pain scale	1, 3, 6 and 12 months
Quality of life by EORCT QLQ-C30	Quality of life by EORCT QLQ-C30 questionnaire	1, 6 and 12 months
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

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Geovanne P Mauro, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Multiple myeloma; Palliative care; Radiotherapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: NP 465/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No