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

NCT05336383 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-1139NCI-2022-03304
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Plasma Cell Neoplasm; Malignant Plasma Cell Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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)

  through study completion, an average of 1 year

• 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

  through study completion, an average of 1 year

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

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

Radiation Therapy DRUG

Given by Infusion

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Penny Fang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Penny Fang, MD

CONTACT

(832) 260-1389; pfang@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: May 31, 2022
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)