Is NCT07665307 recruiting in New York, NY?

Yes, NCT07665307 is currently recruiting participants at its New York, NY location. This multiple myeloma clinical trial is actively enrolling qualified participants.

How do I join the multiple myeloma clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Multiple Myeloma Clinical Trial in New York, NY

About This Multiple Myeloma Study in New York

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.

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07665307) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Myeloma Treatment Options in New York, NY

If you're searching for multiple myeloma treatment options in New York, NY, this clinical trial (NCT07665307) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple myeloma clinical trials near you to find additional studies recruiting in your area.

Multiple Myeloma Clinical Trial in New York, NY

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