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Radiation Therapy for Multiple Myeloma

Phase 2

Recruiting

Led By Penny Fang, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is diagnosed with multiple myeloma

Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is a Phase II study to determine the preliminary safety and efficacy of salvage radiation treatment after BCMA CAR-T therapy in subjects with RRMM.

Who is the study for?

This trial is for adults over 18 with relapsed refractory multiple myeloma (RRMM) who have had standard BCMA CAR-T cell therapy but still show active disease on scans. They must be able to consent and have at least one treatable myeloma lesion. Pregnant women or those planning chemotherapy within two weeks of radiation are excluded.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of salvage radiation treatment after BCMA CAR-T therapy in patients with RRMM. Up to five areas can receive radiation, with doses adjusted by the physician. The main goals are to see how many respond to treatment and how long their response lasts.See study design

What are the potential side effects?

Potential side effects from salvage radiation may include skin irritation, fatigue, nausea, loss of appetite, and localized pain where the radiation is targeted. Long-term risks could involve damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple myeloma.

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I am 18 years old or older.

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I have a myeloma lesion treatable with radiation.

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I have been treated with BCMA CAR-T cell therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of response (DoR) among responders

Overall response rate (ORR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation TherapyExperimental Treatment1 Intervention

Radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20Gy (or equivalent dose in 2Gy fractions of 10-21Gy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,316 Total Patients Enrolled

76 Trials studying Multiple Myeloma

5,787 Patients Enrolled for Multiple Myeloma

Penny Fang, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Penny FangPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05336383 — Phase 2

Multiple Myeloma Research Study Groups: Radiation Therapy

Multiple Myeloma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT05336383 — Phase 2

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336383 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Radiation Therapy attained official endorsement from the FDA?

"The safety of Radiation Therapy is rated a 2 because, while there are some indications that it is safe, no data has been collected to prove the treatment's effectiveness."

Answered by AI

What is the current capacity of this clinical trial to accept participants?

"Affirmative. Clinicaltrials.gov's information indicates that this study, which was introduced on the 31st of May 2022, is presently recruiting. The trial aims to enlist 30 individuals from a single clinical site."

Answered by AI

Is there capacity for enrolment in this research project?

"Affirmative, clinicaltrials.gov has data confirming that this medical trial is presently enrolling patients. It was originally listed on May 31st 2022 and the last update to its information occurred July 9th 2022; 30 participants are needed from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma

2022. "Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05336383.