NCT06270888

Hypofractionation (Radiation) Trial for Multiple Myeloma

An i3+3 Phase I Hypofractionation Trial for Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. In this study, there will be 4 different radiation schedules, ranging from 1-10 daily treatments. Participants in this study will be assigned to one of the dose schedules, and they will know this ahead of time. The study team will evaluate whether the shorter course of radiation is safe by monitoring and evaluating any side effects participants have that are related to the radiation schedule. As part of the research-related activities, the study team will monitor participants' side effects using assessments by their doctors; this will occur before, during, and after radiation therapy for a total of 2 years after radiation.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
RADIATION	Radiation	Radiation given for cancer treatment. Radiation is usually an outpatient procedure completed over the course of 1-6 weeks. High-energy radiation will be delivered to a focused area of the body using a treatment machine called a linear accelerator. Unlike surgery, there are no invasive procedures other than inserting an IV during the radiation planning session. Radiation uses a mold that is customized to fit your body. This mold will be made in the radiation planning session and be used during treatment to keep you from moving. The mold is necessary for very accurate targeting of your tumor. During the procedure, the radiation therapy team will also confirm the exact location that needs to be treated using x-rays.

Timeline

• Start date: 2025-09-08
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-02-21
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States