Actively Recruiting
Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function
Led by Washington University School of Medicine · Updated on 2026-03-11
16
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
A
American Cancer Society, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal function, leading to an urgent, unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population. In addition, renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations. This study is testing the hypotheses that: 1. low-dose total body irradiation (TBI) in combination with cyclophosphamide (Cy) as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function 2. low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansion/persistence and disease response rates as those seen with standard lymphodepleting chemotherapy (fludarabine / cyclophosphamide).
CONDITIONS
Official Title
Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of multiple myeloma.
- Renal insufficiency, defined as eGFR < 45 by MDRD formula.
- At least 18 years of age.
- ECOG performance status 64 1.
- Meets standard of care indication for cilta-cel (per FDA approval).
- Absolute neutrophil count (ANC) 65 1.0 k/cumm; retesting allowed if neutropenia is due to bridging or leading therapies.
- Prior autologous hematopoietic cell transplant with graft containing 652.0 x 10^6 CD34+ cells/kg body weight if applicable.
- Availability of adequate cryopreserved autologous stem cells (652.0 x 10^6 CD34+ cells/kg body weight) for autologous stem cell boost if needed.
- Women of childbearing potential and men must agree to use adequate contraception during study participation.
- Ability to understand and willingness to sign informed consent; legally authorized representatives may consent on behalf of participants.
You will not qualify if you...
- Prior or concurrent malignancy that could interfere with safety or efficacy assessment, except those not meeting this definition.
- Currently receiving other investigational agents.
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, or unstable arrhythmia.
- Cardiac function below New York Heart Association Class 2B.
- Pregnant or breastfeeding; women must have a negative pregnancy test within 14 days of study entry.
- HIV infection without effective anti-retroviral therapy and undetectable viral load for 6 months.
- Detectable chronic hepatitis B virus on suppressive therapy.
- Untreated or uncured hepatitis C infection or detectable viral load; treated and cured HCV patients are eligible.
- Ongoing treatment for HCV with undetectable viral load are eligible.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Michael J Slade, M.D., MSCI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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