NCT05996367

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-myeloma

Timeline
39mo left

Started Jul 2023

Longer than P75 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jul 2023Jul 2029

First Submitted

Initial submission to the registry

July 31, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

July 31, 2023

Last Update Submit

August 9, 2023

Conditions

Multiple Myeloma

Keywords

Multiple myelomaPalliative careRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Retreatment rate at 6 months

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

    6 months after radiotherapy

Secondary Outcomes (8)

  • Local control

    6 months and 12 months

  • Progression-free survival

    12 months

  • Overall survival

    12 months

  • Bone event-free survival

    6 months

  • Pain relief by the numerical rating pain scale

    1, 3, 6 and 12 months

  • +3 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL

Single-dose radiation to involved-site

Radiation: Single-dose involved-site radiotherapy

Interventions

Single-dose involved-site radiotherapyRADIATION

Single-dose of 8 Gy at involved-site radiotherapy

Single Arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Geovanne P Mauro, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geovanne P Mauro, PhD

CONTACT

+551126617058geovanne.mauro@hc.fm.usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 18, 2023

Study Start

July 31, 2023

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2029

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)