Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06270888

Hypofractionation (Radiation) Trial for Multiple Myeloma

Led by University of Chicago · Updated on 2026-03-30

30

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study if for people who have been diagnosed with multiple myeloma and their doctors are recommending radiation to help treat it. Typically, radiation consists of 2-3 weeks of external beam radiation therapy. Doctors leading this study would like to see if a shorter radiation course (i.e., hypofractionation) for pelvic radiation is safe for multiple myeloma. Because participants in this study will receive a shortened radiation course, each daily treatment dose that is delivered would be slightly higher than normal. This higher daily dose would be delivered because the study team would like to see if higher doses of radiation are as safe given over a shorter number of days compared to 2-3 weeks. The purpose of this study is to make sure that hypofractionation is safe and effective for individuals with multiple myeloma.

CONDITIONS

Official Title

Hypofractionation (Radiation) Trial for Multiple Myeloma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study procedures
  • Men or women aged 18 years or older
  • Clinically confirmed relapsed or refractory multiple myeloma with up to 5 bone lesions suitable for radiation
  • Measurable disease with tumor lesions between 0.25 cc to 65 cc in size
  • Eastern Cooperative Oncology Group performance status of 2 or better
  • Adequate organ function confirmed by lab tests
  • Women of childbearing potential must have a negative pregnancy test within 72 hours before starting and agree to use contraception during and up to 5 months after treatment
  • Men sexually active with women of childbearing potential must agree to contraception during and up to 7 months after treatment and avoid sperm donation
  • Women who are breastfeeding or pregnant are excluded
Not Eligible

You will not qualify if you...

  • Spinal instability neoplastic score (SINS) greater than 13 or Mirels' score greater than 9
  • Receiving concurrent anti-myeloma or systemic therapy
  • Not recovered from adverse events related to prior treatments (except steroids, neuropathy grade 2 or less, or alopecia)
  • Prior radiation therapy delivering more than 10% dose to the planned treatment area
  • Chemotherapy within 2 weeks or monoclonal antibody/small molecule therapy within 7 days before radiation
  • Known additional malignancies that could interfere with study results unless approved by investigator
  • History of non-infectious pneumonitis requiring steroids or evidence of interstitial lung disease
  • Current seizure disorder
  • Any condition or abnormality interfering with participation or study results as judged by investigator
  • Psychiatric or substance abuse disorders interfering with cooperation
  • Pregnant, breastfeeding, or planning to conceive or father children during the study and 120 days after last dose
  • Active Hepatitis B or C infection if treating liver lesions
  • Significant cardiovascular disease including recent heart attack, stroke, uncontrolled angina, serious arrhythmias, severe heart failure, or oxygen dependency
  • Concurrent use of statins unless stable for over 3 months without CK rise
  • Clinically significant muscle disorders or conditions elevating creatine kinase levels
  • Prisoners or involuntarily incarcerated individuals
  • Compulsory detention for psychiatric or physical illness

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

Y

Yasmin Hasan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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