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

Primary Purpose

Multiple Myeloma, Plasma Cell Neoplasm, Malignant Plasma Cell Neoplasm

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Radiation Therapy

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05336383

First Posted

April 13, 2022

Last Updated

October 5, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05336383

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 31, 2022 (Actual)

Primary Completion Date

December 7, 2023 (Anticipated)

Study Completion Date

December 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma, Plasma Cell Neoplasm, Malignant Plasma Cell Neoplasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiation Therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Radiation Therapy

Intervention Description

Given by Infusion

Primary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

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

Title

Duration of response (DoR) among responders

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Penny Fang, MD

Phone

(832) 260-1389

pfang@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Penny Fang, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Penny Fang, MD

Phone

832-260-1389

pfang@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Penny Fang, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

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

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