295 Participants Needed

Long-term Follow-up for Cilta-cel in Multiple Myeloma

Recruiting at 56 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is ciltacabtagene autoleucel (cilta-cel) safe for humans?

Ciltacabtagene autoleucel (cilta-cel) has been shown to have a tolerable safety profile in patients with multiple myeloma, with adverse effects ranging from mild to life-threatening, but mostly manageable. It has a consistent safety profile over a longer follow-up period.12345

What data supports the effectiveness of the treatment Cilta-cel in multiple myeloma?

Cilta-cel, a type of CAR-T cell therapy, has shown strong and lasting responses in patients with multiple myeloma who have already tried other treatments, according to studies like CARTITUDE-1. It has been effective in improving patients' quality of life and has a safety profile that is generally manageable.12567

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals who have previously received at least one dose of ciltacabtagene autoleucel (cilta-cel) in a company-sponsored study for multiple myeloma and have consented to participate in this long-term follow-up.

Inclusion Criteria

Participants who have provided informed consent for this stud
You have previously taken cilta-cel in a study sponsored by the company.
Participants who have provided informed consent for this study

Timeline for a Trial Participant

Initial Follow-up

Participants are monitored for safety and effectiveness after treatment with cilta-cel, focusing on new incidences of serious adverse events and infections.

5 years
At least 1 visit per year

Extended Follow-up

Participants continue to be monitored for long-term safety, including serious hematologic disorders and adverse events.

10 years
At least 1 visit per year

Long-term Safety Monitoring

Participants are assessed for delayed adverse events and long-term safety profile of cilta-cel, including monitoring for new malignancies and autoimmune disorders.

15 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cilta-cel
Trial Overview The study focuses on collecting data over an extended period to monitor delayed side effects and understand the long-term safety of cilta-cel, which is used to treat multiple myeloma.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cilta-celExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Ciltacabtagene autoleucel (cilta-cel) therapy significantly improved health-related quality of life (HRQoL) in patients with relapsed/refractory multiple myeloma, with a notable decrease in reported symptoms such as pain and fatigue from 85.2% at baseline to 22.2% by Day 184.
The majority of patients (70.8%) felt that cilta-cel met or exceeded their treatment expectations, highlighting its efficacy and the positive impact of a long treatment-free period on their overall health perception.
Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study.Cohen, AD., Hari, P., Htut, M., et al.[2023]
Ciltacabtagene autoleucel (cilta-cel) demonstrated a significantly higher overall response rate (84% vs. 28%) and longer progression-free survival in patients with relapsed/refractory multiple myeloma compared to standard non-CAR-T therapies, based on a comparison of 113 patients in the CARTITUDE-1 study and 190 patients from the MAMMOTH dataset.
In the modified intent-to-treat population, cilta-cel showed an even more impressive overall response rate of 96% compared to 30% in the MAMMOTH cohort, indicating its potential as a highly effective treatment option for patients who have exhausted other therapies.
Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma.Costa, LJ., Lin, Y., Cornell, RF., et al.[2022]
Ciltacabtagene autoleucel (cilta-cel) is a CAR T-cell therapy that effectively targets B-cell maturation antigen (BCMA) in patients with relapsed or refractory multiple myeloma, showing early and long-lasting responses based on the Phase 1b/2 CARTITUDE-1 study.
While cilta-cel has a tolerable safety profile with manageable adverse effects, it generally demonstrates better efficacy compared to another CAR T-cell therapy, idecabtagene vicleucel (ide-cel), although both therapies have comparable adverse events.
Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma.Chekol Abebe, E., Yibeltal Shiferaw, M., Tadele Admasu, F., et al.[2022]

Citations

Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study. [2023]
Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma. [2022]
Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma. [2022]
Ciltacabtagene Autoleucel, an Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up. [2023]
Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. [2023]
Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician's Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. [2022]
Cilta-cel OK'd for Multiple Myeloma. [2022]
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