Cilta-cel + Talquetamab for Multiple Myeloma
(MonumenTAL-8 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety of two treatments, Cilta-cel (a type of CAR-T cell therapy) and Talquetamab, for individuals with multiple myeloma, a type of blood cancer. It targets those who have tried at least three previous treatments without improvement. Participants who have undergone CAR-T therapy before are not eligible. The trial focuses on individuals with a measurable disease who have not received certain specific therapies. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ciltacabtagene autoleucel (cilta-cel) is approved for treating some patients with multiple myeloma, a type of blood cancer. This approval indicates it has passed safety tests for this condition. Studies indicate that cilta-cel can cause side effects, but it remains safe for people with this illness.
Talquetamab is another treatment under study for multiple myeloma. Recent research has found that talquetamab is generally well-tolerated by patients. Some experienced side effects, but these were usually manageable.
Researchers are testing cilta-cel and talquetamab together to assess their combined safety. Although this combination is still under study, both treatments have shown promising safety results individually. This ongoing research aims to ensure that using them together is also safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Ciltacabtagene Autoleucel (Cilta-cel) combined with Talquetamab for treating relapsed and/or refractory multiple myeloma because they offer a novel approach compared to traditional therapies like chemotherapy or proteasome inhibitors. Cilta-cel is a type of CAR-T cell therapy, which means it uses specially engineered T-cells to target and destroy myeloma cells, potentially offering a more personalized and powerful attack against cancer. Talquetamab, on the other hand, is an antibody that targets a specific protein on myeloma cells, enhancing the immune system's ability to fight the disease. Together, these treatments could provide a more effective and targeted strategy to manage multiple myeloma, especially for patients who have not responded well to existing options.
What evidence suggests that Cilta-cel and Talquetamab might be effective treatments for multiple myeloma?
Research shows that Ciltacabtagene Autoleucel (Cilta-cel) may effectively treat relapsed or refractory multiple myeloma, a type of blood cancer. One study found that Cilta-cel helped patients live longer without their disease worsening compared to other treatments, especially for those who had already tried many therapies. In this trial, participants will receive a combination of Cilta-cel and Talquetamab, another new treatment under study for multiple myeloma. The goal of combining these two treatments is to enhance their effectiveness against this challenging cancer. Early results suggest that this combination could offer new hope for patients with high-risk multiple myeloma.12456
Who Is on the Research Team?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Participants with newly diagnosed multiple myeloma undergo daratumumab, lenalidomide, and dexamethasone (DRd) induction therapy
Bridging Therapy
Participants with relapsed and/or refractory multiple myeloma receive multiple cycles of talquetamab bridging therapy
CAR-T Therapy
Participants receive Ciltacabtagene Autoleucel (Cilta-cel) therapy
Consolidation Treatment
Participants receive multiple cycles of talquetamab consolidation treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ciltacabtagene Autoleucel
- Talquetamab
Ciltacabtagene Autoleucel is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Relapsed and refractory multiple myeloma after one or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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