Cilta-cel for Multiple Myeloma

(CARTITUDE-10 Trial)

Recruiting at 7 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must be taking: DRd, VRd, DVRd

Disqualifiers: Frailty, Allergies, Oxygen, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of ciltacabtagene autoleucel, a type of cell therapy, for individuals with newly diagnosed multiple myeloma, a type of blood cancer. The study compares two methods of preparing the body for treatment: one without fludarabine and another with a combination of cyclophosphamide and fludarabine, both chemotherapy drugs. Individuals diagnosed with multiple myeloma who have completed some initial therapy might be suitable candidates, particularly if they cannot or choose not to undergo high-dose chemotherapy with a stem cell transplant. The trial seeks participants who have at least partially responded to their initial treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ciltacabtagene autoleucel, or cilta-cel, maintains a consistent safety record across various studies. In a large group of patients treated with cilta-cel, 89% responded positively, and 70% achieved a complete response, meaning their disease was undetectable on tests. These studies also indicate that cilta-cel's safety remains stable over time, even in real-world settings outside of clinical trials.

While cilta-cel is generally well-tolerated, it can cause side effects like any treatment. Some patients experience mild to moderate effects, but serious side effects can also occur. Discussing potential risks with the trial team is important, as they can provide more details based on the latest research and individual health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Ciltacabtagene Autoleucel, or cilta-cel, for multiple myeloma because it offers a novel approach compared to standard treatments like proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. Unlike these traditional therapies, cilta-cel is a CAR-T cell therapy, which genetically modifies a patient's own T-cells to specifically target and attack myeloma cells. This personalized approach could potentially lead to more effective and longer-lasting remissions. Additionally, cilta-cel is given as a one-time infusion, which contrasts with the ongoing treatment schedules required by current therapies, potentially reducing the treatment burden for patients.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that ciltacabtagene autoleucel, or cilta-cel, holds promise in treating multiple myeloma, a type of blood cancer. In earlier studies, nearly 89% of patients who received this treatment responded positively, with 70% showing no detectable cancer afterward. This trial will evaluate cilta-cel in two different cohorts. In Cohort A, participants will receive a conditioning regimen of cyclophosphamide followed by cilta-cel infusion. In Cohort B, participants will receive a conditioning regimen of cyclophosphamide and fludarabine followed by cilta-cel infusion. This approach is particularly important for patients whose cancer has returned or did not respond to other treatments. The treatment modifies a patient's own immune cells to enhance their ability to fight cancer, making it a personalized therapy. While not everyone benefits, these results suggest cilta-cel can be very effective for many people with multiple myeloma. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed multiple myeloma who can't have high-dose chemo with stem cell transplant due to age, health issues, or personal choice. They must be relatively active (ECOG score 0-1), have had 3-5 cycles of specific induction therapy with a partial response at least, and meet certain disease measurement criteria.

Inclusion Criteria

I am not eligible for intense chemotherapy with stem cell transplant due to my age, health conditions, or personal choice.

I am fully active or restricted in physically strenuous activity but can do light work.

I've had 3-5 cycles of specific cancer treatment and my condition has partially improved.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen) prior to the main treatment

4-8 weeks

Conditioning and Treatment

Participants receive a conditioning regimen of cyclophosphamide (and fludarabine for Cohort B) for 3 days, followed by cilta-cel IV infusion on Day 1

1 week

Post-treatment

Participants enter the post-treatment phase starting on Day 113, lasting until end of study or cohort completion

Up to 3 years and 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years and 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Ciltacabtagene Autoleucel

Trial Overview The study tests the effectiveness and safety of Ciltacabtagene Autoleucel (cilta-cel) in two scenarios: one without Fludarabine in lymphodepletion (reducing white blood cells before treatment) and another where cilta-cel follows a regimen including Cyclophosphamide and Fludarabine.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 4 Interventions

Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide and fludarabine daily for 3 days, followed by Ciltacel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

Group II: Cohort A Experimental Treatment 3 Interventions

Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

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

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/2411.2/532383/Real-World-Efficacy-Outcomes-of-Ciltacabtagene

Real-World Efficacy Outcomes of Ciltacabtagene Autoleucel in ... Real-world efficacy outcomes of Ciltacabtagene Autoleucel in relapsed refractory multiple myeloma: a comparative study with the Cartitude-1 trial.

2. clinical-lymphoma-myeloma-leukemia.com clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(25)04226-0/fulltext

A Comparative Study with the Cartitude-1 Trial Forty-five percent of RW patients did not meet the inclusion criteria for C-1. The overall response rate was lower in the RW group (88% vs. 97%, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39365257/

Safety and efficacy of standard-of-care ciltacabtagene ... Overall and complete response rates were as follows: all patients who received cilta-cel (N = 236), 89% and 70%; patients receiving conforming ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00760

Long-Term (≥5-Year) Remission and Survival After ... We describe overall survival (OS), ≥5-year progression-free outcomes, associated biomarkers, and safety, with a median study follow-up of 61.3 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265025042260

Real-World Efficacy Outcomes of Ciltacabtagene ... Real-World Efficacy Outcomes of Ciltacabtagene Autoleucel in Relapsed Refractory Multiple Myeloma: A Comparative Study with the Cartitude-1 ...

6. ashpublications.org ashpublications.org/blood/article/145/1/85/518044/Safety-and-efficacy-of-standard-of-care

Safety and efficacy of standard-of-care ciltacabtagene ... Prior BCMA-TT was associated with inferior survival outcomes in our cohort, particularly for patients who received prior BCMA-TT within 6 months ...

7. multiplemyelomahub.com multiplemyelomahub.com/medical-information/real-world-data-on-the-safety-and-efficacy-of-cilta-cel-in-patients-with-rrmm

Real-world data on the safety and efficacy of cilta-cel in ... We summarize results from a retrospective analysis assessing the safety and efficacy of ciltacabtagene autoleucel in a real-world population ...