Multiple MyelomaPhase 1NCT06270888
Hypofractionation (Radiation) Trial for Multiple Myeloma
A Phase 1 study testing Radiation in people with Multiple Myeloma, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 1 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- General inclusion criteria:
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- 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).
- Participants must have measurable disease as defined by RECIST Version 1.1, including at least one tumor lesion that meets criteria for radiation.
- . 0.25 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.
- 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.
- 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).
- 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.
- Participants who are males and who are sexually active with 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 7 months post last dose of study drug(s). In addition, male participants must be willing to refrain from sperm donation during this time.
- Participants who are azoospermic males are exempt from contraceptive requirements.
- Investigators shall counsel women of childbearing potential , and male participants who are sexually active with women of childbearing potential , on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of < 1% when used consistently and correctly.
Who cannot join
- 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.
- Note: subjects with greater than grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
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- 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 additional malignancy that could confuse analysis of on-study treatment. Inclusion of all study participants with more than one malignancy must be discussed and approved by the PI.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Cancer Clinical Trials Office, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
About this study
Official title: An i3+3 Phase I Hypofractionation Trial for Multiple Myeloma
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.
Read the 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
- Being tested
- Radiation
- Keywords
- multiple myeloma, radiation, bone marrow
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Radiation of Per Fraction
Maximum tolerated dose per fraction as assessed by rate of reported dose-limiting toxicities among participants.
Measured: 2 years
Secondary outcomes (5)
Rate of Grade 3 or Higher Adverse Events
The rate of grade 3 or higher adverse events as defined by Common Terminology Criteria for Adverse Events 5.0 that occur within 1 month from the start of radiation.
Measured: 1 month from start of radiation
Rate of Long-Term Adverse Events
The rate of long-term adverse events (after 1 month) from the end of radiation measured by an assessment of spinal osseous lesions using spinal instability neoplastic score (SINS) criteria and computed tomography (CT) imaging at first follow up.
Measured: 2 Years
Overall Response Rate
Overall response rate as assessed by clinical notes/ study records.
Measured: 2 years
Progression-free Survival
Progression-free as assessed by clinical notes/study records.
Measured: 2 years
Local Control of the treated Lesion
Local control of the treated lesion as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start8 Sep 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasmin Hasan, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270888
- Sponsor's protocol ID
- IRB23-1011
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An i3+3 Phase I Hypofractionation Trial for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06270888
- Acronym / sponsor ID
- IRB23-1011
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, radiation, bone marrow
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Dose Schedule 1 | Experimental | Radiation: RadiationIn 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. |
| Group 2 - Dose Schedule 2 | Experimental | Radiation: RadiationIn 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. |
| Group 3 - Dose Schedule 3 | Experimental | Radiation: RadiationIn 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. |
| Group 4 - Dose Schedule 4 | Experimental | Radiation: RadiationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Type of Participant and Disease Characteristics
- Age and Reproductive Status
- Investigators shall counsel women of childbearing potential , and male participants who are sexually active with women of childbearing potential , on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of < 1% when used consistently and correctly.
Key exclusion criteria (28 listed)
- Target Population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationRadiation 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. | Radiation | Group 1 - Dose Schedule 1, Group 2 - Dose Schedule 2, Group 3 - Dose Schedule 3, Group 4 - Dose Schedule 4 |
Primary outcome
Maximum Tolerated Dose of Radiation of Per Fraction
Time frame: 2 years
Maximum tolerated dose per fraction as assessed by rate of reported dose-limiting toxicities among participants.
5 secondary outcomes
Rate of Grade 3 or Higher Adverse Events
Time frame: 1 month from start of radiation
Rate of Long-Term Adverse Events
Time frame: 2 Years
Overall Response Rate
Time frame: 2 years
Progression-free Survival
Time frame: 2 years
Local Control of the treated Lesion
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasmin Hasan, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiation in people with Multiple Myeloma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmin Hasan, MD ((773) 702-2856, yhasan@radonc.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of Radiation of Per Fraction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.