Low-dose radiation and cyclophosphamide before cell therapy for myeloma with kidney impairment
Tests low-dose body radiation with cyclophosphamide before cilta-cel in myeloma with kidney impairment.
Plain-language title generated from the registry record
Registry title: Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function
Key facts
- Where
- St Louis, United StatesSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma and reduced kidney function who qualify for the CAR T therapy cilta-cel. It tests low-dose total body irradiation plus cyclophosphamide before the CAR T cells.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Multiple myeloma confirmed by tissue tests. Kidney function reduced: eGFR below 45 (MDRD formula). Fit enough for daily activity: ECOG performance status 1 or lower. Meets the standard indication for cilta-cel per FDA approval.
- Earlier treatment
- If a person had an earlier autologous stem cell transplant, the graft had to contain at least 2.0 x 106 CD34+ cells/kg. Enough stored own stem cells (at least 2.0 x 106 CD34+ cells/kg) must be available. Cannot be taking any other investigational drug now.
- Biomarker or test result
- Blood count: ANC at least 1.0 k/cumm. People with HIV, hepatitis B or hepatitis C can join only if the virus is controlled or undetectable, as the record describes.
Main reasons for not taking part
- Another cancer that could interfere with judging safety or effect of the treatment
- Uncontrolled illness, such as active infection or unstable heart problems
- Heart disease worse than New York Heart Association class 2B
- Pregnant or breastfeeding
- HIV, hepatitis B or hepatitis C that is not controlled as the record requires
Read by machine on 9 November 2026.
Where in United States
- Washington University School of MedicineSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Washington University School of Medicine
- Trial code
- NCT06623630
- Record updated
- 11 March 2026
- Original description
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.Read full original descriptionShow less
A Pilot Safety and Feasibility Study of Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function
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).
Inclusion: Histologically confirmed diagnosis of multiple myeloma; Renal insufficiency, defined as eGFR < 45 by MDRD formula; At least 18 years of age; ECOG performance status ≤ 1; Meets standard of care indication for cilta-cel (per FDA approval); ANC ≥ 1.0 k/cumm. If neutropenia is present at initial screening but is judged to be attributable to bridging and/or leading therapies, patients can be re-tested within the screening period to confirm eligibility; Patients with a history of prior autologous hematopoietic cell transplant (AHCT) must have received a graft containing ≥2.0 x 106 CD34+ cells/kg body weight; Availability of adequate cryopreserved autologous stem cells (≥2.0 x 106 CD34+ cells/kg body weight) to allow for an autologous stem cell boost in case of prolonged cytopenias; Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately; Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion: Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial; Currently receiving any other investigational agents; Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better; HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible; History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible; Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible; Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.