Multiple MyelomaNCT07665307
Delayed Toxicities Post-CAR-T
An observational study of Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
This is an observational umbrella protocol evaluating toxicities after CAR-T therapy with ciltacabtagene autoleucel (cilta-cel) for RRMM, with a goal to identify key inflammatory features contributing to toxicities, define non-invasive biomarkers to guide clinical monitoring, and evaluate treatment strategies to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jul 2026to 18 Jun 2029
- Phase
- Observational
- 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
Study population: Participants with documented diagnosis of MM and be eligible for commercial CAR-T therapy with cilta-cel.
Who may be able to join
- Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with cilta-cel. Patients planned for standard of care cilta-cel whose cell product is considered out of specification after manufacture will still be eligible to proceed with the current study protocol if proceeding with cilta-cel infusion
- All patients must have ECOG Performance Status ≤ 2.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Subjects with active plasma cell leukemia (defined as either 5% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L)
- Subjects with active Central Nervous System (CNS) involvement with multiple myeloma
- Cardiac conditions including:
- New York Heart Associated class 3 or 4 congestive heart failure
Show all 40Show fewer
- Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment
- History of clinically significant ventricular arrhythmia
- History of severe non-ischemic cardiomyopathy
- Stroke or seizure within 6 months of enrollment
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
- Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk, per the discretion of the treating physician or PI
- Patients with a positive PCR test for hepatitis B virus or hepatitis C virus indicating active infection. Patients with positive serologic testing indicating exposure will need confirmatory testing by PCR.
- Patients who are seropositive for HIV
- Prior or concurrent malignancy, except for the following:
- Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.
- Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.
- Localized prostate cancer (N0M0):
- with a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance,
- with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence; or
- any history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence per the discretion of the treating physician or PI
- Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
- Breast cancer: adequately treated lobular carcinoma in situ, or ductal carcinoma in situ, or history of localized breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence.
- Any other cancer from which the subject has been disease free for > 3 years prior to study entry, or considered cured with minimal risk of disease recurrence.
- Prior treatment with CAR-T
- Prior allogeneic stem cell transplant
- Major cardiac surgery within 8 weeks prior to cilta-cel; all other major surgery within 4 weeks prior to cilta-cel.
- Patients who are pregnant or breastfeeding
- Subjects with following physical and laboratory test findings:
- Absolute neutrophil count < 1 x 109/L without growth factor support within 1 week, or absolute neutrophil count < 0.5 x 109/L for patients with documented Duffy-null blood typing
- Platelets < 50 x 109/L without transfusion support within 1 week
- Creatinine clearance < 30 ml/min according to the Cockroft-Gault formula:
- Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dl]
- Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dl]
- Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)
- AST or ALT ≥ 3x ULN
- Corrected serum calcium > 13.5 mg/dL
- Are also excluded:
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mount Sinai
New York, New York, 10029
Vikram Madan, MPH, vikram.madan@mssm.edu
Nicole Devito, nicole.devito@mountsinai.org
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Maximilian Merz, merzm@mskcc.org
Maximilian Merz
- Recruiting
UCSF Medical Center
San Francisco, California, 94143
Ajai Chari, ajai.chari@ucsf.edu
Anupama Kumar, anupama.kumar@ucsf.edu
About this study
Official title: An Umbrella Observational Study to Determine Novel Actionable Biomarkers, Mechanisms, and Mitigation of Rare Chimeric Antigen Receptor T Cell (CAR-T) Toxicities in Relapsed/Refractory Multiple Myeloma (RRMM)
This is an observational umbrella protocol evaluating toxicities after CAR-T therapy with ciltacabtagene autoleucel (cilta-cel) for RRMM, with a goal to identify key inflammatory features contributing to toxicities, define non-invasive biomarkers to guide clinical monitoring, and evaluate treatment strategies to reduce morbidity for patients. Toxicities of interest will include neurotoxicity, hematologic, and gastrointestinal events. Patients planned to receive cilta-cel as part of their standard of care multiple myeloma therapy will be enrolled. All patients will have baseline evaluation at the time of leukapheresis and cilta-cel infusion, as well as longitudinal blood, bone marrow, cerebrospinal fluid (CSF), and gastrointestinal (GI) samples collected for translational assessment. Patients who experience toxicities of interest as evaluated by their clinical team will undergo additional evaluation and sample collection, as guided by the involved organ system (e.g. CSF for neurologic toxicity, endoscopic evaluation with colonic biopsies for colitis), with monitoring for resolution of symptoms on therapy. Additional patients from Mount Sinai or other centers [University of California San Francisco (UCSF), Memorial Sloan Kettering Cancer Center (MSKCC)] who have previously been or will be treated with cilta-cel and are participating in institutional biobanks will similarly be included for ongoing sample collected per local protocols, and samples from patients experiencing toxicities of interest will be sent to Mount Sinai for analysis to supplement the prospective cohort.
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, myeloma, car-t toxicity, neurotoxicity, car-t, cilta-cel
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients who are planned to go for CAR-T to treat their multiple myeloma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cilta-cel peak expansion (Cmax)
Cilta-cel peak expansion (Cmax), using the maximum percentage of circulating CD3+ T cells with the cilta-cel construct measured by flow cytometry from day of infusion through day +28 post cilta-cel infusion
Measured: 28 days post infusion
Cilta-cel peak expansion (Cmax)
Cilta-cel peak expansion (Cmax), using the maximum absolute count (cells/µL) of cells with the cilta-cel construct, measured by flow cytometry from day of infusion through day +28 post cilta-cel infusion
Measured: 28 days post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Jul 2026
- Primary completion18 Jun 2029 (estimated)
- Study completion18 Jun 2029 (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 Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir Parekh, Icahn School of Medicine at Mount Sinai
- Investigators
- Samir Parekh, Principal investigator, Professor , MD/PHD, Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665307
- Sponsor's protocol ID
- STUDY-26-00444
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Umbrella Observational Study to Determine Novel Actionable Biomarkers, Mechanisms, and Mitigation of Rare Chimeric Antigen Receptor T Cell (CAR-T) Toxicities in Relapsed/Refractory Multiple Myeloma (RRMM)
- ClinicalTrials.gov ID
- NCT07665307
- Acronym / sponsor ID
- STUDY-26-00444
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, myeloma, car-t toxicity, neurotoxicity, car-t, cilta-cel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 18 Jun 2029 (estimated)
- Study completion
- 18 Jun 2029 (estimated)
- First posted
- 24 Jun 2026 (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.
This is an observational umbrella protocol evaluating toxicities after CAR-T therapy with ciltacabtagene autoleucel (cilta-cel) for RRMM, with a goal to identify key inflammatory features contributing to toxicities, define non-invasive biomarkers to guide clinical monitoring, and evaluate treatment strategies to reduce morbidity for patients. Toxicities of interest will include neurotoxicity, hematologic, and gastrointestinal events. Patients planned to receive cilta-cel as part of their standard of care multiple myeloma therapy will be enrolled. All patients will have baseline evaluation at the time of leukapheresis and cilta-cel infusion, as well as longitudinal blood, bone marrow, cerebrospinal fluid (CSF), and gastrointestinal (GI) samples collected for translational assessment. Patients who experience toxicities of interest as evaluated by their clinical team will undergo additional evaluation and sample collection, as guided by the involved organ system (e.g. CSF for neurologic toxicity, endoscopic evaluation with colonic biopsies for colitis), with monitoring for resolution of symptoms on therapy. Additional patients from Mount Sinai or other centers [University of California San Francisco (UCSF), Memorial Sloan Kettering Cancer Center (MSKCC)] who have previously been or will be treated with cilta-cel and are participating in institutional biobanks will similarly be included for ongoing sample collected per local protocols, and samples from patients experiencing toxicities of interest will be sent to Mount Sinai for analysis to supplement the prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –Patients who are planned to go for CAR-T to treat their multiple myeloma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with documented diagnosis of MM and be eligible for commercial CAR-T therapy with cilta-cel.
Key inclusion criteria (5 listed)
- Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with cilta-cel. Patients planned for standard of care cilta-cel whose cell product is considered out of specification after manufacture will still be eligible to proceed with the current study protocol if proceeding with cilta-cel infusion
- All patients must have ECOG Performance Status ≤ 2.
Key exclusion criteria (40 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Subjects with active plasma cell leukemia (defined as either 5% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L)
- Subjects with active Central Nervous System (CNS) involvement with multiple myeloma
- Cardiac conditions including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cilta-cel peak expansion (Cmax)
Time frame: 28 days post infusion
Cilta-cel peak expansion (Cmax), using the maximum percentage of circulating CD3+ T cells with the cilta-cel construct measured by flow cytometry from day of infusion through day +28 post cilta-cel infusion
Cilta-cel peak expansion (Cmax)
Time frame: 28 days post infusion
Cilta-cel peak expansion (Cmax), using the maximum absolute count (cells/µL) of cells with the cilta-cel construct, measured by flow cytometry from day of infusion through day +28 post cilta-cel infusion
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 10 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Samir Parekh principal investigator
Professor , MD/PHD, Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 3 sites 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 5 inclusion and 40 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 Vikram Madan (347.835.3446, vikram.madan@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cilta-cel peak expansion (Cmax) (time frame: 28 days post infusion). The study lists 2 primary outcomes in all. 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 10 Aug 2026.