Recruiting
Phase 2

Salvage Radiation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05336383

Conditions

Multiple Myeloma

Plasma Cell Neoplasm

Malignant Plasma Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Plasma Cell Neoplasm

Malignant Plasma Cell Neoplasm

Study ID

NCT05336383

Start date

May 31, 2022

Status verified date

Apr, 2026

Completion date

Dec 7, 2026

Anticipated

Primary completion date

Dec 7, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
2. Subject is diagnosed with multiple myeloma
3. Subject previously received treatment with standard of care BCMA CAR-T cell therapy
4. Day 30 or later PET scan or other imaging scan after CAR-T infusion shows active disease
5. Subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation
6. Able to provide informed consent

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment
2. Subject is undergoing active treatment for another malignancy other than multiple myeloma
3. Pregnant women will be excluded from this study.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation Therapy

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

Interventions

Radiation Therapy

Given by Infusion

Primary outcome measure

  • Overall response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]
  • Duration of response (DoR) among responders [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Penny Fang, MD

(832) 260-1389pfang@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Penny Fang, MD

832-260-1389pfang@mdanderson.org

Principal Investigator:

Penny Fang, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.