10 Participants Needed

Cilta-cel + Talquetamab for Multiple Myeloma

(MonumenTAL-8 Trial)

Recruiting at 8 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
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

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are in Cohort 2, you should not have taken a strong CYP450 inducer recently. It's best to discuss your current medications with the trial team.

Is the combination of Cilta-cel and Talquetamab safe for humans?

Cilta-cel, a type of CAR T-cell therapy, has been approved for treating multiple myeloma and generally has a tolerable safety profile, with side effects that are mostly manageable. It has shown consistent safety over time, although patients may experience a range of adverse effects from mild to severe.12345

What makes the treatment Cilta-cel + Talquetamab unique for multiple myeloma?

Cilta-cel is a personalized CAR T-cell therapy that targets BCMA on cancer cells, offering deep and long-lasting responses in patients with relapsed or refractory multiple myeloma, even after many other treatments have failed. It is unique because it uses the patient's own modified T-cells to attack the cancer, and it has shown better efficacy compared to similar treatments like ide-cel.12346

What data supports the effectiveness of the treatment Cilta-cel + Talquetamab for Multiple Myeloma?

Ciltacabtagene autoleucel (cilta-cel) has shown strong and lasting responses in patients with multiple myeloma who have already tried many other treatments, and it has been approved by the FDA for this use. Patients have reported improvements in their quality of life after receiving this treatment.12367

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 people with high-risk multiple myeloma. Participants must have had at least three prior treatments and show disease progression or lack of response to the last therapy. Newly diagnosed patients ineligible for stem cell transplant can join too. They should be fairly active (ECOG score 0-1) and women able to bear children need a negative pregnancy test.

Inclusion Criteria

I have been diagnosed with multiple myeloma and it can be measured.
* Cohorts 1 and 3: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy. Cohort 2: Be newly diagnosed MM and considered ineligible for high-dose chemotherapy with autologous stem cell transplant (ASCT)
I am fully active or restricted in physically strenuous activity but can do light work.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants with newly diagnosed multiple myeloma undergo daratumumab, lenalidomide, and dexamethasone (DRd) induction therapy

8-12 weeks

Bridging Therapy

Participants with relapsed and/or refractory multiple myeloma receive multiple cycles of talquetamab bridging therapy

4-8 weeks

CAR-T Therapy

Participants receive Ciltacabtagene Autoleucel (Cilta-cel) therapy

1-2 weeks

Consolidation Treatment

Participants receive multiple cycles of talquetamab consolidation treatment

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years and 5 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ciltacabtagene Autoleucel
  • Talquetamab
Trial Overview The study tests the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in combination with other drugs like Lenalidomide, Dexamethasone, and Daratumumab in treating high-risk multiple myeloma. It aims to find out how well these combinations work.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) TherapyExperimental Treatment2 Interventions

Ciltacabtagene Autoleucel is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Carvykti for:
🇪🇺
Approved in European Union as Carvykti for:

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) significantly improved progression-free survival in patients with lenalidomide-refractory multiple myeloma, with a median progression-free survival not reached in the cilta-cel group compared to 11.8 months in the standard-care group, based on a phase 3 trial with 419 participants.
The cilta-cel group also showed higher overall response rates (84.6% vs. 67.3%) and complete response rates (73.1% vs. 21.8%) compared to standard care, although most patients experienced grade 3 or 4 adverse events, including cytokine release syndrome.
Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma.San-Miguel, J., Dhakal, B., Yong, K., et al.[2023]
Ciltacabtagene autoleucel (cilta-cel) has been approved by the FDA as a fifth-line treatment option for patients with relapsed or refractory multiple myeloma, marking a significant advancement in therapy options for this challenging condition.
Cilta-cel is notable for being the second chimeric antigen receptor T-cell therapy targeting BCMA to receive regulatory approval within a year, highlighting the rapid development of innovative treatments in this area.
Cilta-cel OK'd for Multiple Myeloma.[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]
Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. [2023]
Cilta-cel OK'd for Multiple Myeloma. [2022]
Ciltacabtagene autoleucel for the treatment of multiple myeloma. [2023]
Component Costs of CAR-T Therapy in Addition to Treatment Acquisition Costs in Patients with Multiple Myeloma. [2023]
Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma. [2022]
Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security