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Proton Beam Therapy

Shorter Radiation Therapy for Multiple Myeloma

Phase 1

Recruiting

Led By Yasmin Hasan, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Participants must be males and females ≥ 18 years of age at the time of informed consent

Participants who are women must not be breastfeeding

Must not have

Participants must not have had prior radiation therapy (defined as less than 10 percent of prior prescription dose) to the area planning to be treated with radiation

Participants must not have had uncontrolled or significant cardiovascular disease including, but not limited to, any of the following: myocardial infarction or stroke/transient ischemic attack within the past 6 months, uncontrolled angina within the past 3 months, any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes), history of other clinically significant heart disease (e.g. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, significant pericardial effusion, or myocarditis), cardiovascular disease-related requirement for daily supplemental oxygen therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people with multiple myeloma who are recommended to have radiation therapy. The doctors want to test if a shorter course of radiation treatment, with slightly higher daily doses, is safe and

Who is the study for?

This trial is for people with multiple myeloma who need radiation therapy. It's testing if a shorter course of higher-dose radiation (hypofractionation) over fewer days can be as safe and effective as the standard 2-3 week treatment.

What is being tested?

The study is examining hypofractionated radiation therapy, which means giving larger doses of radiation in each session but reducing the total number of sessions. The goal is to see if this approach maintains safety and effectiveness.

What are the potential side effects?

Potential side effects may include skin irritation, fatigue, mild swelling or pain at the treatment site. Higher doses per session could possibly increase these effects compared to traditional schedules.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am not currently breastfeeding.

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I am mostly bedridden due to my health condition.

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My multiple myeloma has returned or is not responding to treatment, and I have up to 5 bone lesions treatable with radiation.

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I have a tumor that can be measured and is suitable for radiation.

Exclusion Criteria

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

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I haven't had significant radiation therapy to the area that's now being considered for treatment.

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I have not had serious heart problems or needed daily oxygen for heart issues in the recent past.

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I do not have interstitial lung disease.

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I have never needed steroids for non-infectious lung inflammation.

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My spine is stable enough for radiation, based on specific medical scores.

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I do not have active Hepatitis B or C.

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I am not currently on any treatment for myeloma.

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I do not have a current seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose of Radiation of Per Fraction

Secondary study objectives

Local Control of the treated Lesion

Overall Response Rate

Progression-free Survival

+2 more

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT03043807

81%

fatigue

38%

hot flashes

38%

neuropathy

19%

alopecia;

19%

dysgeusia

15%

hiccups

15%

nausea

15%

skin alterations

12%

diarrhea

12%

gastritis

12%

edema (lower extremity)

12%

rash

12%

constipation

anxiety

xerosis

elevated ALT

hematochezia

cough

elevated AST

xerostomia

general body aches

pruritis

nail discoloration

fever

anemia

epistaxis

infusion related reaction

neutropenia

neutropenic fever

gastrointestinal reflux

pain (bilateral legs)

mucositis

pain (joint);

anorexia

nail ridging

weight gain

hematuria

urinary tract obstruction

oral candidiasis

insomnia

depression

dyspnea

arthritis

pain (pelvis)

memory impairment

heartburn

100%

80%

60%

40%

20%

Study treatment Arm

Chemohormonal and Definitive Therapy After Prostatectomy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4 - Dose Schedule 4Experimental Treatment1 Intervention

In this study, there will be 4 different radiation schedules, ranging from 1-10 daily treatments. Participants will be assigned to one of the dose schedules and they will know this ahead of time. The study doctor will tell each participant which study group and dose schedule they been assigned. For most participants, the actual time on the radiation treatment machine will be in the range of 30 to 60 minutes. The mold will be removed after the treatment. The number of treatments to each tumor will depend on which treatment group the participant is enrolled on: The longest possible treatment group would be 10 treatments in duration of about 2 weeks of treatment and the shortest possible treatment group would be 1 treatment.

Group II: Group 3 - Dose Schedule 3Experimental Treatment1 Intervention

Group III: Group 2 - Dose Schedule 2Experimental Treatment1 Intervention

Group IV: Group 1 - Dose Schedule 1Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 2

~780

0 / 13Eligibility criteria met