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NCT05201781 · Janssen Research & Development, LLC

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

What this study is about

The purpose of this study is to collect long-term follow-up data on delayed side effects after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

View original scientific description

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

Interventions

DRUG

Cilta-cel

Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.

Primary outcome measures

Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy

Time frame: Up to 15 years

Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.

Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder

Time frame: Up to 15 years

Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.

Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder

Time frame: Up to 15 years

Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.

Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia

Time frame: From year 1 up to year 5

Number of participants with new incidence of Grade \>=3 hematologic disorder including hypogammaglobulinemia will be reported.

Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia

Time frame: From year 6 up to year 15

Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).

Number of Participants with New Incidence of Grade >= 3 Infection

Time frame: From year 1 up to year 5

Number of participants with new incidence of Grade \>=3 infection will be reported.

Number of Participants with Serious Infection

Time frame: From year 6 up to year 15

Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.

Number of Participants with Serious Adverse Events (SAEs)

Time frame: From year 1 up to year 5

A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Number of Participants with Related Serious Adverse Events Assessed by the Investigator

Time frame: From year 6 up to year 15

Number of participants with related serious adverse events assessed by the investigator will be reported. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
  • Participants who have provided informed consent for this study

Where

  • Phoenix, Arizona
  • Duarte, California
  • San Francisco, California
  • Stanford, California
  • Tampa, Florida
  • Atlanta, Georgia
  • Chicago, Illinois
  • Indianapolis, Indiana
  • Westwood, Kansas
  • Boston, Massachusetts
  • Detroit, Michigan
  • Rochester, Minnesota

And 12 more locations — see the full list below.

Related conditions & keywords

Multiple Myeloma

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations

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1 of 295 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Phoenix

Arizona

Location available
RECRUITING

Duarte

California

Location available
RECRUITING

San Francisco

California

Location available
RECRUITING

Stanford

California

Location available
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Atlanta

Georgia

Location available
RECRUITING

Chicago

Illinois

Location available
RECRUITING

Chicago

Illinois

Location available
RECRUITING

Indianapolis

Indiana

Location available

And 19 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Multiple Myeloma Trials by City

Browse all multiple myeloma clinical trials in these cities — not just this study.

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Looking for Multiple Myeloma Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Multiple Myeloma Treatment Options in Phoenix, Arizona

If you're searching for Multiple Myeloma treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Duarte, San Francisco and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Multiple Myeloma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 295 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Multiple Myeloma?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Multiple Myeloma

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Multiple Myeloma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05201781. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.