Back to resultsProspective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Single-dose involved-site radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Palliative care, Radiotherapy
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.
Sites / Locations
- University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Single-dose radiation to involved-site
Outcomes
Primary Outcome Measures
Retreatment rate at 6 months
Percentage of patients that needed a second corse of radiation for painful bone lesions
Secondary Outcome Measures
Local control
Local control by Recist 1.1
Progression-free survival
Progression-free survival
Overall survival
Overall survival
Bone event-free survival
by description from Raje et al. The Lancet 2018
Pain relief by the numerical rating pain scale
reduction on opioid and single analgesics intake and altered value in the rating pain scale
Pain flair incidence
Enhanced pain by at least 2 levels at the numerical rating pain scale
Quality of life by EORCT QLQ-C30
Quality of life by EORCT QLQ-C30 questionnaire
Quality of life by EORCT QLQ-C30 and MY-24
Quality of life by EORCT MY-24 myeloma complementary questionnaires
Full Information
NCT ID
NCT05996367
First Posted
July 31, 2023
Last Updated
August 9, 2023
Sponsor
Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05996367
Brief Title
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
Official Title
Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
July 31, 2028 (Anticipated)
Study Completion Date
July 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, Palliative care, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Single-dose radiation to involved-site
Intervention Type
Radiation
Intervention Name(s)
Single-dose involved-site radiotherapy
Intervention Description
Single-dose of 8 Gy at involved-site radiotherapy
Primary Outcome Measure Information:
Title
Retreatment rate at 6 months
Description
Percentage of patients that needed a second corse of radiation for painful bone lesions
Time Frame
6 months after radiotherapy
Secondary Outcome Measure Information:
Title
Local control
Description
Local control by Recist 1.1
Time Frame
6 months and 12 months
Title
Progression-free survival
Description
Progression-free survival
Time Frame
12 months
Title
Overall survival
Description
Overall survival
Time Frame
12 months
Title
Bone event-free survival
Description
by description from Raje et al. The Lancet 2018
Time Frame
6 months
Title
Pain relief by the numerical rating pain scale
Description
reduction on opioid and single analgesics intake and altered value in the rating pain scale
Time Frame
1, 3, 6 and 12 months
Title
Pain flair incidence
Description
Enhanced pain by at least 2 levels at the numerical rating pain scale
Time Frame
1, 3, 6 and 12 months
Title
Quality of life by EORCT QLQ-C30
Description
Quality of life by EORCT QLQ-C30 questionnaire
Time Frame
1, 6 and 12 months
Title
Quality of life by EORCT QLQ-C30 and MY-24
Description
Quality of life by EORCT MY-24 myeloma complementary questionnaires
Time Frame
1, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geovanne P Mauro, PhD
Phone
+551126617058
Email
geovanne.mauro@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geovanne P Mauro, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geovanne Mauro, PhD
Phone
+551126617058
Email
geovanne.mauro@hc.fm.usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
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