Salvage radiation treatment after CAR-T therapy for relapsed multiple myeloma
Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma
PHASE2 · M.D. Anderson Cancer Center · NCT05336383
This study is testing if radiation treatment can help people with relapsed multiple myeloma feel better after they’ve had CAR-T therapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | CAR-T, chemotherapy, radiation, CAR T |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05336383 on ClinicalTrials.gov |
What this trial studies
This Phase II study aims to evaluate the safety and efficacy of salvage radiation therapy following B-cell maturation antigen (BCMA) CAR-T cell therapy in patients with relapsed refractory multiple myeloma (RRMM). Participants will have active disease as indicated by imaging scans after CAR-T infusion and will receive radiation treatment targeting plasmacytomas. The study will enroll 30 patients and assess the objective response rate and duration of response among responders at 6 months. Additional exploratory objectives include analyzing immune cell profiles and changes in cytokines and microbiome.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with RRMM who have previously received BCMA CAR-T therapy and show active disease on imaging.
Not a fit: Patients who are scheduled for salvage chemotherapy less than 14 days after radiation treatment or those with other active malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with RRMM who have not responded adequately to CAR-T therapy.
How similar studies have performed: While this approach is novel in the context of combining salvage radiation with CAR-T therapy for RRMM, similar studies in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Penny Fang, MD — M.D. Anderson Cancer Center
- Study coordinator: Penny Fang, MD
- Email: pfang@mdanderson.org
- Phone: (832) 260-1389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Plasma Cell Neoplasm, Malignant Plasma Cell Neoplasm