A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
NCT Number: NCT06550895
Acronym: MonumenTAL-8
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma
Interventions: DRUG: Cilta-cel|DRUG: Talquetamab|DRUG: Daratumumab|DRUG: Lenalidomide|DRUG: Dexamethasone
Sponsor: Janssen Research & Development, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-23
Completion Date: 2028-04-30

Summary:
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).

Primary Outcome Measures: Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death., Up to 3 years and 5 months
Secondary Outcome Measures: Percentage of Participants With Overall Response (OR), The percentage of participants who have a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria will be reported., Up to 3 years and 5 months|Percentage of Participants with Very Good Partial Response (VGPR) or Better, The percentage of participants who achieve a VGPR or better response according to the IMWG response criteria will be reported., Up to 3 years and 5 months|Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR), The percentage of participants with best overall response of CR or sCR will be reported according to IMWG criteria., Up to 3 years and 5 months|Duration of Response (DOR), DOR is defined as the time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (PD) (defined in the IMWG response criteria) or death due to any cause, whichever occur first., Up to 3 years and 5 months|Time to Response (TTR), TTR is defined as the time between date of the first study treatment and the first efficacy evaluation that the participant met all criteria for PR or better., Upto 3 years and 5 months|Progression Free Survival (PFS), PFS is defined as the time from the date of the first study treatment to the date of first documented disease progression (defined in the IMWG response criteria), or death due to any cause, whichever occurs first., Up to 3 years and 5 months|Overall Survival, Overall Survival is measured from the date of the first study treatment to the date of the participant's death., Up to 3 years and 5 months|Percentage of Participants with Minimal Residual Disease (MRD) Negativity, The percentage of participants who achieve MRD-negativity at a threshold of 10\^-5 at any timepoint after the date of the first study treatment and before disease progression or start of any subsequent antimyeloma therapy will be reported., Up to 3 years and 5 months|Percentage of Participants with Sustained MRD-Negativity, The percentage of participants who sustained MRD-negative status, as determined by next generation sequencing (NGS) with sensitivity of 10\^-5, for at least 6 months without examination showing MRD-positive or PD in between will be reported., Up to 3 years and 5 months