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

Study Overview
=================
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.

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

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Radiation: Single-dose involved-site radiotherapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Single-dose radiation to involved-site | Radiation: Single-dose involved-site radiotherapy<br>* Single-dose of 8 Gy at involved-site radiotherapy<br>|

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 |
| --- | --- | --- |
| Local control | Local control by Recist 1.1 | 6 months and 12 months | 
| Progression-free survival | Progression-free survival | 12 months | 
| Overall survival | Overall 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple myeloma, Palliative care, Radiotherapy