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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05336383
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18.2
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Plasma Cell Neoplasm; Malignant Plasma Cell Neoplasm	Drug: Radiation Therapy	Phase 2

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 31, 2022
• Anticipated Primary Completion Date: Dec 7, 2023
• Anticipated Study Completion Date: Dec 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
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; Given by Infusion

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Penny Fang, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05336383
• Other Study ID Numbers: 2021-1139; NCI-2022-03304
• First Posted: Apr 20, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma

Study Results

No Results Posted as of Jul 12, 2022