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Radiation Therapy

Low-Dose Radiotherapy for Multiple Myeloma with Bone Pain

N/A

Recruiting

Led By Leslie Ballas, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Painful bone metastasis (index lesion) that has a radiographic correlate

Eastern Cooperative Oncology Group (ECOG) 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after completion of radiation therapy

Awards & highlights

Study Summary

This trial is testing how well low-dose radiotherapy works to treat bone pain in patients with multiple myeloma that has spread to the bone.

Who is the study for?

This trial is for patients with multiple myeloma and painful bone metastases. Participants must have a pain score of at least 2, confirmed diagnosis, and be able to consent. They can have had any number of prior treatments but should not be pregnant or have received radiation on the index lesion.Check my eligibility

What is being tested?

The study is examining the effectiveness of low-dose radiotherapy in alleviating bone pain caused by multiple myeloma that has spread to bones. It aims to see if this approach is more convenient and results in fewer side effects than traditional doses.See study design

What are the potential side effects?

Low-dose radiotherapy may cause skin irritation at the treatment site, fatigue, mild swelling or discomfort around treated bones, and a slight risk of more serious complications like damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a painful bone metastasis that shows up on scans.

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I am able to get out of my bed or chair and move around.

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I have been diagnosed with multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after completion of radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after completion of radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after completion of radiation therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain response

Secondary outcome measures

Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)

Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC QLQ-C30)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (low-dose radiation therapy)Experimental Treatment3 Interventions

Patients receive low-dose radiation therapy at consecutive business days 1 and 2 in the absence of disease progression or unacceptable toxicity. Patients with no pain relief may receive additional radiotherapy at 4 weeks following initial radiotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,188 Total Patients Enrolled

3 Trials studying Multiple Myeloma

69 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,906 Total Patients Enrolled

579 Trials studying Multiple Myeloma

189,031 Patients Enrolled for Multiple Myeloma

Leslie Ballas, MDPrincipal InvestigatorUniversity of Southern California

Media Library

Low-Dose Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03858205 — N/A

Multiple Myeloma Research Study Groups: Treatment (low-dose radiation therapy)

Multiple Myeloma Clinical Trial 2023: Low-Dose Radiotherapy Highlights & Side Effects. Trial Name: NCT03858205 — N/A

Low-Dose Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03858205 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographical areas is this scientific research being conducted?

"This trial is now welcoming participants at 8 distinct sites, including Boston, Los Angeles and Minneapolis. To reduce the strain of travel on yourself or your family if you decide to join this medical study, it is advised to select a site proximal to you."

Answered by AI

Is this research endeavor currently enrolling participants?

"Affirmative. Clinicaltrials.gov documents that this clinical research is actively recruiting participants, having been initially posted on March 11th 2019 and last amended February 25th 2022. In total, 8 sites are aiming to recruit 100 individuals for the trial."

Answered by AI

What is the present enrollment figure for this research project?

"This medical trial necessitates the enrollment of 100 qualified individuals. Patients in Boston, MA and Los Angeles, CA can access the study's resources at Dana-Farber Cancer Institute and USC / Norris Comprehensive Cancer Center respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma

2019. "Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03858205.