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Active, not recruitingNCT05336383Updated Oct 6, 2026

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

A Phase 2 interventional study of Radiation Therapy in Multiple Myeloma, Plasma Cell Neoplasm and Malignant Plasma Cell Neoplasm, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Updated Oct 6, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Objectives

Primary Objective:

  • The primary objective of the study is to evaluate the preliminary efficacy of salvage radiation therapy after BCMA CAR-T cell therapy in subjects with RRMM.

Secondary Objectives:

  • Evaluate the safety of and other efficacy parameters of radiation treatment after BCMA CAR-T cell therapy in subjects with RRMM

Exploratory Objectives:

  • Evaluate the immunophenotype and/or expression profile, and perform functional bulk and single cell analysis of CAR T cells, endogenous T cells as well as other immune cells in the blood, bone marrow and/or tumor tissue with BCMA CAR-T therapy and RT
  • Evaluate changes in the levels of cytokines, chemokines, and soluble factors in the blood with BCMA CAR-T therapy and RT
  • Evaluate changes in T cell receptor repertoire with BCMA CAR-T therapy and RT
  • Evaluate gut microbiome of patients treated with BCMA CAR-T therapy and RT
02

Conditions studied

  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Malignant Plasma Cell Neoplasm
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 30 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study 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

    Drug: Radiation Therapy

Interventions

  • DrugRadiation Therapy

    Given by Infusion

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR)

    Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma (Kumar, 2016)

    Time frame: through study completion, an average of 1 year

  2. Duration of response (DoR) among responders

    Time from first documentation of response (PR or greater) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05336383
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Apr 20, 2022
Start date
May 31, 2022
Primary completion
Dec 7, 2026 (estimated)
Completion
Dec 7, 2026 (estimated)
Last update
Oct 6, 2026

Study contacts

Penny Fang, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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