RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-05-31
Study Completion:2026-12-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05336383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
  2. 2. Subject is diagnosed with multiple myeloma
  3. 3. Subject previously received treatment with standard of care BCMA CAR-T cell therapy
  4. 4. Day 30 or later PET scan or other imaging scan after CAR-T infusion shows active disease
  5. 5. Subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation
  6. 6. Able to provide informed consent
  1. 1. Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment
  2. 2. Subject is undergoing active treatment for another malignancy other than multiple myeloma
  3. 3. Pregnant women will be excluded from this study.

Contacts and Locations

Study Contact

Penny Fang, MD
CONTACT
(832) 260-1389
pfang@mdanderson.org

Principal Investigator

Penny Fang, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Penny Fang, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-31
Study Completion Date2026-12-07

Study Record Updates

Study Start Date2022-05-31
Study Completion Date2026-12-07

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Malignant Plasma Cell Neoplasm