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RecruitingLast updated: 18 November 2024

MonumenTAL-8: The purpose of this study is to understand the safety of immunotherapies (Cilta-cel and Talquetamab) in people with high-risk multiple myelomaA Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Clinical summary

Summary

Eligible participants will be assigned to one of three cohorts based on their diagnosis and treatment history.

Cohort 1 will enrol people with relapsed and/or refractory multiple myeloma who will receive Cilta-cel infusion (intravenously) followed by multiple cycles of talquetamab (as an injection under the skin, also known as subcutaneously) consolidation treatment.

Cohort 2 will enrol people with newly diagnosed multiple myeloma who are considered eligible for high-dose chemotherapy with autologous stem cell transplant (ASCT). These participants will undergo induction therapy with daratumumab (subcutaneously), lenalidomide (orally) and dexamethasone (orally or intravenously). This will be followed by Cilta-cel therapy (IV infusion) and multiple cycles of talquetamab (subcutaneously) consolidation treatment.

Cohort 3 will enrol people with relapsed or refractory multiple myeloma, who will receive multiple cycles of talquetamab (subcutaneously) bridging therapy, followed by Cilta-Cel therapy (IV infusion). 

Conditions

This trial is treating patients with high risk multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

MonumenTAL-8

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT06550895
  • 64407564MMY2008; 2023-507989-76; 2023-507989-76-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Eligibility

Inclusion

  • Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
  • 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)
  • Cohorts 1 and 3: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening

Exclusion

  • Cohorts 1 and 3: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy. Cohort 2: Received any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  • Cohorts 1 and 3: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (<)12 weeks before apheresis/first dose of study treatment
  • Cohort 2: Received a strong cytochrome P450 (CYP450) inducer within 5 half-lives prior to daratumumab, lenalidomide and dexamethasone (DRd) induction therapy
  • Receive live, attenuated vaccine within 4 weeks of enrollment
  • Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are currently receiving treatment for your cancer.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

There may be additional criteria to what is listed here, speak to your doctor to confirm whether this trial is right for you.

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