NCT05336383Active, not recruitingPhase 2
Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
This study 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. The study population will consist of subjects with RRMM previously treated with SOC BCMA CAR-T cell therapy with active disease on the D30+ PET or other imaging scan after CAR-T infusion. Patients who are planned for salvage chemotherapy less than 14 days after completion of radiation treatment will be excluded. 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). Final dose, target, and technique are per treating radiation physician discretion within these guidelines. Thirty patients will be enrolled. The co-primary endpoints are objective response rate (ORR) at 6 months and duration of response (DOR) among responders.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 13 Apr 2022
- Start date
- 31 May 2022
- Primary completion date
- 7 Dec 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Multiple myeloma
- NCT number
- NCT05336383
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 31 May 2022 to the primary completion date, 7 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment
Other illness
- Subject is undergoing active treatment for another malignancy other than multiple myeloma
Other
- The presence of any of the following will exclude a subject from enrollment:
- Pregnant women will be excluded from this study.
Who the study is looking for
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
- Subject is diagnosed with multiple myeloma
- Subject previously received treatment with standard of care BCMA CAR-T cell therapy
- Day 30 or later PET scan or other imaging scan after CAR-T infusion shows active disease
- Subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation
- Able to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.