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

Phase 2

Recruiting

• Conditions: Malignant Plasma Cell Neoplasm; Multiple Myeloma; Plasma Cell Neoplasm
• Interventions: Drug: Radiation Therapy

• Registration Number: NCT05336383
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Study Start: 2022-05-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-12-07
• Study Completion: 2026-12-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation Therapy	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

Primary Outcome Measures

Name	Time	Method
Duration of response (DoR) among responders	through study completion, an average of 1 year	Time from first documentation of response (PR or greater) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Overall response rate (ORR)	through study completion, an average of 1 year	Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma (Kumar, 2016)

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States