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Radiation Therapy

Low-Dose Radiotherapy for Multiple Myeloma with Bone Pain

N/A

Recruiting

Led By Adam Garsa, 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

Must not have

Index lesion has received prior radiation therapy or prior palliative surgery

Pathologic fracture or impending fracture at the site of the index lesion or planned surgical fixation of the bone at the index lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after completion of radiation therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My main tumor was treated with radiation or surgery for symptom relief.

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I have a broken bone or one that might break where my cancer is or I need surgery to fix a bone where my cancer is.

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My cancer is affecting my spine or skull.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain response

Secondary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met