Hypofractionation (Radiation) Trial for Multiple Myeloma

NCT06270888 | Recruiting Phase 1

• 1 other identifier: IRB23-1011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 (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

Multiple Myeloma

Keywords

multiple myeloma; radiation; bone marrow

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of Radiation of Per Fraction

  Maximum tolerated dose per fraction as assessed by rate of reported dose-limiting toxicities among participants.

  2 years

Secondary Outcomes (5)

• Rate of Grade 3 or Higher Adverse Events

  1 month from start of radiation

• Rate of Long-Term Adverse Events

  2 Years

• Overall Response Rate

  2 years

• Progression-free Survival

  2 years

• Local Control of the treated Lesion

  2 years

Study Arms (4)

Group 1 - Dose Schedule 1

EXPERIMENTAL

In this study, there will be 4 different radiation schedules, ranging from 1-10 daily treatments. Participants will be assigned to one of the dose schedules and they will know this ahead of time. The study doctor will tell each participant which study group and dose schedule they been assigned. For most participants, the actual time on the radiation treatment machine will be in the range of 30 to 60 minutes. The mold will be removed after the treatment. The number of treatments to each tumor will depend on which treatment group the participant is enrolled on: The longest possible treatment group would be 10 treatments in duration of about 2 weeks of treatment and the shortest possible treatment group would be 1 treatment.

Radiation: Radiation

Group 2 - Dose Schedule 2

EXPERIMENTAL

In this study, there will be 4 different radiation schedules, ranging from 1-10 daily treatments. Participants will be assigned to one of the dose schedules and they will know this ahead of time. The study doctor will tell each participant which study group and dose schedule they been assigned. For most participants, the actual time on the radiation treatment machine will be in the range of 30 to 60 minutes. The mold will be removed after the treatment. The number of treatments to each tumor will depend on which treatment group the participant is enrolled on: The longest possible treatment group would be 10 treatments in duration of about 2 weeks of treatment and the shortest possible treatment group would be 1 treatment.

Radiation: Radiation

Group 3 - Dose Schedule 3

EXPERIMENTAL

In this study, there will be 4 different radiation schedules, ranging from 1-10 daily treatments. Participants will be assigned to one of the dose schedules and they will know this ahead of time. The study doctor will tell each participant which study group and dose schedule they been assigned. For most participants, the actual time on the radiation treatment machine will be in the range of 30 to 60 minutes. The mold will be removed after the treatment. The number of treatments to each tumor will depend on which treatment group the participant is enrolled on: The longest possible treatment group would be 10 treatments in duration of about 2 weeks of treatment and the shortest possible treatment group would be 1 treatment.

Radiation: Radiation

Group 4 - Dose Schedule 4

EXPERIMENTAL

In this study, there will be 4 different radiation schedules, ranging from 1-10 daily treatments. Participants will be assigned to one of the dose schedules and they will know this ahead of time. The study doctor will tell each participant which study group and dose schedule they been assigned. For most participants, the actual time on the radiation treatment machine will be in the range of 30 to 60 minutes. The mold will be removed after the treatment. The number of treatments to each tumor will depend on which treatment group the participant is enrolled on: The longest possible treatment group would be 10 treatments in duration of about 2 weeks of treatment and the shortest possible treatment group would be 1 treatment.

Radiation: Radiation

Interventions

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.

Group 1 - Dose Schedule 1; Group 2 - Dose Schedule 2; Group 3 - Dose Schedule 3; Group 4 - Dose Schedule 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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.
• Type of Participant and Disease Characteristics
• Men or women ≥ 18 years of age.
• Have clinically confirmed relapsed/refractory Multiple Myeloma with up to 5 osseous lesions that can be treated with radiation therapy (SINS score ≤ 13 or Mirels' score ≤ 9) iii) Have undergone appropriate standard of care treatment options (in the opinion of the treating investigator).
• iv) Participants must have measurable disease as defined by RECIST Version 1.1, including at least one tumor lesion that meets criteria for radiation.
• cc to 65 cc of viable tumor approximately 5 cm in maximal dimension. Tumors larger than 65 cc can be partially treated but the whole tumor should receive at least the minimal prescribed dose confirmed by the study team.
• v) Participants must have an Eastern Cooperative Oncology Group performance status that is greater than or equal to 2 vi) Adequate organ function, as defined by lab values that will be confirmed by the study doctor.
• Age and Reproductive Status
• Participants must be males and females ≥ 18 years of age at the time of informed consent.
• Participants who are women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of study.
• c) Participants who are women must not be breastfeeding. d) Participants who are women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) and up to 5 months post last dose of study drug(s).
• e) Participants who are women of childbearing potential who are continuously not heterosexually active are exempted from contraceptive requirements but still must undergo pregnancy testing as described in this section.

You may not qualify if:

• Target Population
• Participants must not have SINS (spinal instability neoplastic score) less than 13 or Mirels' score less than 9 prior to starting radiation treatment
• Participants must not receive any concurrent anti-myeloma or systemic therapy of any form.
• Participants who have not recovered (i.e. greater than grade 1 or at baseline) from adverse events due to a previously administered agent will be excluded. Participants may receive concurrent steroids.
• i) Note: subjects with greater than grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• ii) Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• iii) Note: subjects with any grade alopecia are an exception to this criterion and may qualify for the study • Participants must not have had prior radiation therapy (defined as less than 10 percent of prior prescription dose) to the area planning to be treated with radiation.
• Participants who have had prior cytotoxic chemotherapy must not receive that therapy within 2 weeks of the initiation of radiation
• Participants who have had prior anti-cancer monoclonal antibody (mAb) or other small molecules must not receive that therapy within 7 days of the initiation of radiation
• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Yasmin Hasan, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Hasan, MD

CONTACT

(773) 702-2856; yhasan@radonc.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 21, 2024
• Study Start: September 8, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)