Cilta-cel + Talquetamab for Multiple Myeloma
(MonumenTAL-8 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?
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:
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