Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270888
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-05
Brief Title:
Hypofractionation Radiation Trial for Multiple Myeloma
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
An i33 Phase I Hypofractionation Trial for Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None