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Recruiting NCT05336383

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

Phase II Interventional Multiple Myeloma Plasma Cell Neoplasm Malignant Plasma Cell Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation Therapy.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Plasma Cell Neoplasm, Malignant Plasma Cell Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Interventions

  • Drug Radiation Therapy
    Given by Infusion

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT05336383 · 2021-1139 · NCI-2022-03304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗