An i3+3 Phase I Hypofractionation Trial for Multiple Myeloma
University of Chicago
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- For entry into the study, the following criteria must be met prior to dosing on Day 1. No exceptions will be granted. Eligibility criteria for this study have been carefully considered to ensure the safety of the study participants and that the results of the study can be used. It is imperative that participants fully meet all eligibility criteria. 1. Signed Written Informed Consent * Participants must be able to give self-consent and then sign and date an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent in accor…
Interventions
- RadiationRadiation
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.
Location
- The University of Chicago Comprehensive Cancer CenterChicago, Illinois