Multiple MyelomaPhase 1NCT06623630
Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function
A Phase 1 study testing Cyclophosphamide, Ciltacabtagene Autoleucel and Total body irradiation in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cyclophosphamide, Ciltacabtagene Autoleucel and Total body irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to 31 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Michael J Slade, M.D., MSCI, 314-454-8304, sladem@wustl.edu
Michael J Slade, M.D., MSCI
About this study
Official title: 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:
- 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
- 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
- Multiple Myeloma
- Being tested
- Cyclophosphamide, Ciltacabtagene Autoleucel, Total body irradiation
- Keywords
- Chimeric antigen receptor T cells, Radiation, Immunotherapy, Renal failure
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Standard of care
Ciltacabtagene AutoleucelDrug
Also called Carvykti, cilta-cel
Standard of care
Total body irradiationRadiation
Also called TBI
Radiation doses delivered to the entire body
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide + Cilta-Cel + TBI | Experimental | All patients will undergo T-cell collection and CAR T manufacturing as per standard of care. Patients will receive cyclophosphamide per standard of care Day -5 to Day -3. They will subsequently receive TBI on Day -1 then and will receive cilta-cel infusion on Day 0. Receives: Drug: Cyclophosphamide; Drug: Ciltacabtagene Autoleucel; Radiation: Total body irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Toxicities considered possibly, probably, or definitely related to TBI-based lymphodepletion as graded per CTCAE v 5.0.
Measured: Through 28 days post cilta-cel
Secondary outcomes (16)
Incidence of treatment related adverse events (TEAEs)
- Graded per CTCAE v 5.0.
- All AEs will be collected from start of treatment through Day 28. After Day 28, only late toxicities of interest will be tracked and recorded.
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Incidence of cytokine release syndrome (CRS)
Measured: Through day 100
Incidence of immune effector cell associated neurotoxicity syndrome (ICANS)
Graded per ASTCT criteria
Measured: Through day 100
Best overall response by IMWG criteria
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Response rate by IMWG criteria
Measured: Day 28 post cilta-cel
Response rate by IMWG criteria
Measured: Day 100 post cilta-cel
Response rate by IMWG criteria
Measured: 1 year post cilta-cel
Measurable residual disease (MRD) as measured by ClonoSeq
Measured: Day 28 post cilta-cel
Measurable residual disease (MRD) as measured by ClonoSeq
Measured: Day 100 post cilta-cel
Measurable residual disease (MRD) as measured by ClonoSeq
Measured: 1 year post cilta-cel
Median duration of response (DoR)
Duration of response (DoR) is defined as the time from onset of response to progression or death due to any reason, whichever occurs earlier.
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Duration of response
Duration of response (DoR) is defined as the time from onset of response to progression or death due to any reason, whichever occurs earlier.
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from start of treatment (Day 0) until date of disease progression.
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Overall survival (OS)
Overall survival (OS) is defined as the time from start of treatment (Day 0) until date of death.
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Area under the curve (AUC) for CAR T expansion as measured by multiparameter flow cytometry.
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Area under the curve (AUC) for CAR T expansion as measured by quantitative polymerase chain reaction (qPCR).
Measured: Through completion of follow-up (estimated to 1 year and 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start4 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Cures Within Reach
- Responsible party
- Sponsor
- Investigators
- Michael J Slade, M.D., MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623630
- Sponsor's protocol ID
- 202410010
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06623630
- Acronym / sponsor ID
- 202410010
- Conditions
- Multiple Myeloma
- Keywords
- Chimeric antigen receptor T cells, Radiation, Immunotherapy, Renal failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Cures Within Reach
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide + Cilta-Cel + TBI | Experimental | Drug: Cyclophosphamide, Drug: Ciltacabtagene Autoleucel, Radiation: Total body irradiationAll patients will undergo T-cell collection and CAR T manufacturing as per standard of care. Patients will receive cyclophosphamide per standard of care Day -5 to Day -3. They will subsequently receive TBI on Day -1 then and will receive cilta-cel infusion on Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideStandard of care | Drug | Cyclophosphamide + Cilta-Cel + TBI |
| Ciltacabtagene AutoleucelAlso: Carvykti, cilta-celStandard of care | Drug | Cyclophosphamide + Cilta-Cel + TBI |
| Total body irradiationAlso: TBIRadiation doses delivered to the entire body | Radiation | Cyclophosphamide + Cilta-Cel + TBI |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: Through 28 days post cilta-cel
Toxicities considered possibly, probably, or definitely related to TBI-based lymphodepletion as graded per CTCAE v 5.0.
16 secondary outcomes
Incidence of treatment related adverse events (TEAEs)
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Incidence of cytokine release syndrome (CRS)
Time frame: Through day 100
Incidence of immune effector cell associated neurotoxicity syndrome (ICANS)
Time frame: Through day 100
Best overall response by IMWG criteria
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Response rate by IMWG criteria
Time frame: Day 28 post cilta-cel
Response rate by IMWG criteria
Time frame: Day 100 post cilta-cel
Response rate by IMWG criteria
Time frame: 1 year post cilta-cel
Measurable residual disease (MRD) as measured by ClonoSeq
Time frame: Day 28 post cilta-cel
Measurable residual disease (MRD) as measured by ClonoSeq
Time frame: Day 100 post cilta-cel
Measurable residual disease (MRD) as measured by ClonoSeq
Time frame: 1 year post cilta-cel
Median duration of response (DoR)
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Duration of response
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Progression-free survival (PFS)
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Overall survival (OS)
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Area under the curve (AUC) for CAR T expansion as measured by multiparameter flow cytometry.
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Area under the curve (AUC) for CAR T expansion as measured by quantitative polymerase chain reaction (qPCR).
Time frame: Through completion of follow-up (estimated to 1 year and 1 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Slade, M.D., MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Ciltacabtagene Autoleucel and Total body irradiation in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J Slade, M.D., MSCI (314-454-8304, sladem@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: Through 28 days post cilta-cel). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.