Active not recruitingPHASE3INTERVENTIONAL

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

This study looks at a new treatment called Cilta-cel, which is a type of CAR-T cell therapy, for people with multiple myeloma. Multiple myeloma is a cancer that affects certain white blood cells. This study compares Cilta-cel to two standard treatment combinations: Pomalidomide, Bortezomib, and Dexamethasone (PVd), or Daratumumab, Pomalidomide, and Dexamethasone (DPd). It's designed for patients aged 18 and over whose multiple myeloma has come back or is no longer responding to previous treatments, particularly lenalidomide. The main goal is to find out if Cilta-cel is more effective than the current standard treatments for these patients. Your doctor will help decide if this study might be right for you.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

419

Start

12 Jun 2020

Estimated completion

09 Apr 2029

Multiple Myeloma

Results

Results from this study

Posted May 2025

Results have been published for this study.

Primary outcome

Progression Free Survival (PFS)

PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease.

Full results on the registry

What is this study about?

This research study is about finding better treatments for multiple myeloma. This is a type of cancer that starts in a kind of white blood cell called a plasma cell. These cells are found in your bone marrow, the spongy tissue inside your bones where blood cells are made. When you have multiple myeloma, these plasma cells grow too much and can cause problems in your bones, kidneys, and immune system.

Doctors are testing a new treatment called Cilta-cel, which uses your own immune cells to fight the cancer. This is a special type of treatment called CAR-T cell therapy. They want to see if Cilta-cel works better than the treatments currently used for people whose multiple myeloma has returned or is no longer responding to their usual medicines. The standard treatments being compared are combinations of existing drugs: either Pomalidomide, Bortezomib, and Dexamethasone, or Daratumumab, Pomalidomide, and Dexamethasone.

The main aim of the study is to compare how well Cilta-cel works against these standard treatments. This means looking at things like how long people live, how long their cancer stays under control, and what side effects they might experience. This study is important because it could lead to a new and more effective treatment option for people with multiple myeloma that is difficult to treat.

Key takeaways

This study compares a new immune cell therapy (Cilta-cel) with current standard treatments.
It's for people with multiple myeloma that has come back or isn't responding to previous drugs.
The new therapy uses your body's own immune cells to fight the cancer.
Your health and treatment response will be closely monitored throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would typically need to be 18 years old or older. Doctors are looking for people who have multiple myeloma that has already been treated one to three times before, and these treatments must have included specific types of drugs called a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD).

Your cancer also needs to have come back or gotten worse, and it must not be responding well to lenalidomide, a common multiple myeloma drug, even if this was from an earlier treatment. The medical team will also check your blood test results to make sure your body, including your blood cell counts, is healthy enough to take part.

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 18 years old or older?
Has your multiple myeloma come back or gotten worse despite previous treatments?
Have you been treated for multiple myeloma one to three times before?
Has your cancer stopped responding well to lenalidomide?
Are your blood test results generally within a healthy range?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups and medical tests. These tests might include blood samples, urine samples, and scans to monitor your health and how your cancer is responding to treatment. You would receive either the new Cilta-cel therapy or one of the standard drug combinations. The specific schedule of visits and treatments would depend on which treatment group you are in, but it would be carefully explained to you by the study team.

After your main treatment phase, there would likely be a period of follow-up visits to continue monitoring your health and the long-term effects of the treatment. The total length of your participation, from beginning to end, would vary but could last for several months to a few years, including regular check-ins even after active treatment finishes.

Potential risks and benefits

Participating in any clinical study comes with potential benefits and potential risks. You might benefit from receiving a new and potentially more effective treatment for your multiple myeloma. However, new treatments like Cilta-cel can have side effects, some of which could be serious. The standard treatments also have known side effects. The study team will explain all potential risks and side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (88)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Mayo Clinic Cancer Center-Scottsdale
Verified postcode
Phoenix, United States
Stanford University Medical Center
Verified postcode
Stanford, United States
Colorado Blood Cancer Institute
Verified postcode
Denver, United States
Yale New Haven Hospital
Verified postcode
New Haven, United States
University Of Miami Leonard M Mille School Of Medicine SCCC
Verified postcode
Miami, United States
University of Iowa Hospitals and Clinics
Verified postcode
Iowa City, United States
University of Kansas
Verified postcode
Westwood, United States
University Of Maryland Medical Center
Verified postcode
Baltimore, United States
Mayo Clinic - Rochester
Verified postcode
Rochester, United States
Washington University School Of Medicine
Verified postcode
St Louis, United States
Hackensack University Medical Center
Verified postcode
Hackensack, United States

Common questions

What is multiple myeloma?

Multiple myeloma is a cancer that affects certain white blood cells (plasma cells) found in your bone marrow.

What is CAR-T cell therapy?

CAR-T cell therapy uses your own immune cells, modified in a lab, to find and kill cancer cells.

Who is this study for?

This study is for adults with multiple myeloma that has returned or is not responding to previous treatments, including lenalidomide.

Will I definitely get the new treatment?

No, participants are randomly assigned to either receive the new Cilta-cel therapy or one of the standard treatment combinations.

Can I stop participating in the study?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your future medical care.