AvailableEXPANDED_ACCESS

Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma

This is a special program offering a treatment called cilta-cel for adults with multiple myeloma, a cancer affecting plasma cells. The treatment being offered here didn't quite meet the usual quality standards for the commercial version of cilta-cel, but doctors believe it might still help patients who have very serious or life-threatening myeloma and few other treatment options. It's for those who cannot easily get the standard cilta-cel treatment. The program aims to make this therapy available when other options, like manufacturing new cells or other cancer treatments, aren't possible or effective. Doctors will carefully decide if this treatment is right for each patient, weighing the potential benefits against any risks.

At a glance

Status

Available

Sponsor

Janssen Scientific Affairs, LLC

Multiple Myeloma

What is this study about?

This program is about a specific treatment called cilta-cel for a type of blood cancer called multiple myeloma. Multiple myeloma affects cells in your bone marrow. Cilta-cel is a very advanced treatment where some of a patient's own immune cells are collected, specially changed in a lab to recognise and fight cancer cells, and then given back to the patient. It's a bit like training your own body to become a super-fighter against the cancer.

Usually, cilta-cel treatment, known commercially as CARVYKTI, has very strict quality checks. This particular program offers cilta-cel that didn't quite meet those usual quality standards. However, doctors believe that for some patients with serious or life-threatening multiple myeloma who have no other good treatment choices, this 'out-of-spec' cilta-cel might still offer a chance for improvement where no other option exists. It's important to understand this isn't the standard commercial version, but it's being offered with careful medical thought.

The main reason for this program is to help patients who have severe multiple myeloma, can't get the standard cilta-cel treatment through their local health system, and for whom other ways of making the treatment or other cancer drugs aren't working or aren't possible. The goal is to provide a potential treatment where few other options remain, always with close medical supervision and in situations where doctors believe the benefits outweigh the risks for the individual patient.

Key takeaways

This program offers a special version of cilta-cel for very serious multiple myeloma.
It's for patients who can't get standard cilta-cel or other treatments.
The treatment offered didn't pass all standard quality checks but is medically reviewed.
Your doctor must decide if the benefits outweigh the risks for you.
It's an option for those with severe, life-threatening forms of the disease.

Who may be eligible?

To be considered for this special program, you would first need to be an adult, aged 18 or over.

Doctors would need to confirm that you have multiple myeloma that is very serious or life-threatening. They would also need to feel that other treatments, or getting a new batch of cilta-cel, are not suitable or possible for you. The medical team would then look at your individual health to decide if the potential benefits of this specific treatment are greater than any possible risks. They must agree that this treatment is truly in your best interest.

Finally, you would need to be able to fully understand what taking part means and agree to it by giving your informed consent. If you are a woman who could become pregnant, you would also need to have negative pregnancy tests before starting certain parts of the treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Do you have multiple myeloma that your doctor says is very serious or life-threatening?
Has your doctor said that other cancer treatments or making new cells for you are not possible or won't work?
Are you able to understand and agree to take part in this program?
If you are a woman who could get pregnant, are you able to have negative pregnancy tests?

Answer every question to see your result.

What does participation involve?

This program is not a typical clinical trial that follows a set plan for everyone. Instead, it's about providing a specific treatment (cilta-cel OOS Therapy) to individuals who desperately need it. The exact details of your involvement, including hospital visits, tests, and follow-up, would be decided by your treating doctor based on what's best for your specific health needs. It would involve careful monitoring by your medical team to see how the treatment is affecting you and to manage any side effects. The total duration of your participation would depend on your individual response to the treatment and your doctor's ongoing medical assessment.

Potential risks and benefits

The potential benefit of this program is that it offers a chance for treatment with cilta-cel for patients with very serious multiple myeloma who have limited other options. While this specific treatment didn't meet all standard quality checks, it is still believed by doctors to potentially help. However, all medical treatments carry risks, and cilta-cel can have significant side effects, some of which can be serious. Your doctor will discuss these in detail. It's very important to remember that as a patient, you always have the right to withdraw from the program at any time if you change your mind or if the treatment is not suitable for you.

Locations (138)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Available
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Available
Cancer Treatment Center of America Phoenix
Verified postcode
Goodyear, United States· Available
HonorHealth Cancer Transplant Institute
Verified postcode
Scottsdale, United States· Available
Mayo Clinic
Verified postcode
Scottsdale, United States· Available
University of Arizona Cancer Center
Verified postcode
Tucson, United States· Available
The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy
Verified postcode
Little Rock, United States· Available
Alta Bates Medical Center Cancer Center
Verified postcode
Berkeley, United States· Available
City of Hope
Verified postcode
Duarte, United States· Available
University of California at San Diego
Verified postcode
La Jolla, United States· Available
USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Available
Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Available

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.

What is cilta-cel?

Cilta-cel is an advanced treatment where your own immune cells are specially trained to find and destroy cancer cells in your body.

Why is this cilta-cel 'out-of-spec'?

This means the treatment didn't quite meet all the usual strict quality checks for the commercially available version, but doctors still believe it could be helpful for patients with severe conditions.

Is this a standard treatment?

No, this is not the standard version of cilta-cel. It's being offered through a special program for patients who have very serious conditions and no other suitable options.

Who decides if I can have this treatment?

Your own doctor, in consultation with a medical review team, will carefully assess if this treatment is the best option for you.

How to find out more

Study Contact

janssenmedinfo@its.jnj.com 1-800-526-7736 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.