RECRUITING

Hypofractionation (Radiation) Trial for Multiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

An i3+3 Phase I Hypofractionation Trial for Multiple Myeloma

Quick Facts

Study Start:2024-02-21

Study Completion:2028-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06270888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 accordance with local regulatory and institutional guidelines. This consent must be obtained before the performance of any protocol-related procedures that are not considered part of normal participant care. * Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. 2. Type of Participant and Disease Characteristics 1. General	1. Target Population * Participants must not have a known history of non-infectious pneumonitis that required steroids for treatment. * Participants must not have evidence of interstitial lung disease. * Participants must not have a current seizure disorder. * Participants must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. * If known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C is detected then patient is not eligible for treatment of liver lesions * 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. * Participants may not concomitantly use statins while on study. However, a patient using statins for over 3 months prior to study drug administration and in stable status without creatine kinase (CK) rise may be permitted to enroll. * Participants may not have current or history of clinically significant muscle disorders (e.g. myositis), recent unresolved muscle injury, or any condition known to elevate serum creatine kinase (CK) levels. * Participants must not be prisoners or be involuntarily incarcerated. * Participants must not be compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Inclusion Criteria

Exclusion 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 accordance with local regulatory and institutional guidelines. This consent must be obtained before the performance of any protocol-related procedures that are not considered part of normal participant care.
* Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
2. Type of Participant and Disease Characteristics
1. General

1. Target Population
* Participants must not have a known history of non-infectious pneumonitis that required steroids for treatment.
* Participants must not have evidence of interstitial lung disease.
* Participants must not have a current seizure disorder.
* Participants must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
* If known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C is detected then patient is not eligible for treatment of liver lesions
* 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.
* Participants may not concomitantly use statins while on study. However, a patient using statins for over 3 months prior to study drug administration and in stable status without creatine kinase (CK) rise may be permitted to enroll.
* Participants may not have current or history of clinically significant muscle disorders (e.g. myositis), recent unresolved muscle injury, or any condition known to elevate serum creatine kinase (CK) levels.
* Participants must not be prisoners or be involuntarily incarcerated.
* Participants must not be compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Contacts and Locations

Study Contact

Yasmin Hasan, MD

CONTACT

(773) 702-2856

yhasan@radonc.uchicago.edu

Principal Investigator

Yasmin Hasan, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

The University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Yasmin Hasan, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-21

Study Completion Date2028-05-01

Study Record Updates

Study Start Date2024-02-21

Study Completion Date2028-05-01

Terms related to this study

Keywords Provided by Researchers

multiple myeloma
radiation
bone marrow

Additional Relevant MeSH Terms

Multiple Myeloma