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

• Sponsor: Instituto do Cancer do Estado de São Paulo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05996367
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Radiation: Single-dose involved-site radiotherapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
• Actual Study Start Date: Jul 31, 2023
• Anticipated Primary Completion Date: Jul 31, 2028
• Anticipated Study Completion Date: Jul 31, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Retreatment rate at 6 months [6 months after radiotherapy]

   Percentage of patients that needed a second corse of radiation for painful bone lesions

Secondary Outcome Measures

1. Local control [6 months and 12 months]

   Local control by Recist 1.1

2. Progression-free survival [12 months]

   Progression-free survival

3. Overall survival [12 months]

   Overall survival

4. Bone event-free survival [6 months]

   by description from Raje et al. The Lancet 2018

5. Pain relief by the numerical rating pain scale [1, 3, 6 and 12 months]

   reduction on opioid and single analgesics intake and altered value in the rating pain scale

6. Pain flair incidence [1, 3, 6 and 12 months]

   Enhanced pain by at least 2 levels at the numerical rating pain scale

7. Quality of life by EORCT QLQ-C30 [1, 6 and 12 months]

   Quality of life by EORCT QLQ-C30 questionnaire

8. Quality of life by EORCT QLQ-C30 and MY-24 [1, 6 and 12 months]

   Quality of life by EORCT MY-24 myeloma complementary questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sao Paulo	São Paulo	Sao Paulo	Brazil	05403-010

Sponsors and Collaborators

• Instituto do Cancer do Estado de São Paulo

Investigators

• Principal Investigator: Geovanne P Mauro, PhD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geovanne Pedro Mauro, Primary Investigator, Instituto do Cancer do Estado de São Paulo
• ClinicalTrials.gov Identifier: NCT05996367
• Other Study ID Numbers: NP 465/23
• First Posted: Aug 18, 2023
• Last Update Posted: Aug 18, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Geovanne Pedro Mauro, Primary Investigator, Instituto do Cancer do Estado de São Paulo: Multiple myeloma; Palliative care; Radiotherapy
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 18, 2023