Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel
NCT Number: NCT06523621
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma
Interventions: DRUG: Nivolumab
Sponsor: Wake Forest University Health Sciences
Collaborators: Atrium Health Levine Cancer Institute|Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2027-11
Locations: Levine Cancer Institute, Charlotte, North Carolina, 28204, United States

Summary:
This study is designed to evaluate if treatment with adjuvant nivolumab improves depth of response in patients with relapsed refractory multiple myeloma (RRMM) who achieve a less-than-ideal response to idecaptagene vicleucel.

Primary Outcome Measures: Depth of Response, Depth of response will be determined for each participant post ide-cel with adjuvant nivolumab indicating if their best overall response is a Complete Response (CR) or stringent Complete Response (sCR). The post-ide-cel disease response assessments will be calculated relative to the participant's pre-ide-cel disease assessment parameters. Responses will be determined per IMWG 2016 response criteria., From enrollment to best response; approximately 5 months after initiating nivolumab
Secondary Outcome Measures: Progression Free Survival (PFS), PFS is defined as the duration of time from ide-cel administration to first occurrence of either progressive disease (PD) or death (from any cause). PD will be objectively determined per IMWG 2016 criteria, where progression date is date of first assessment that identified confirmed PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments., From date of ide-cel administration to date of progression or death, or censored as described; assessed for approximately 4 years|Best Overall Response, Best overall response will be determined for each participant as a categorical variable indicating the participant's best overall response achieved after treatment with nivolumab, according to IMWG 2016 response criteria. The levels for best overall response will include PD, SD, MR PR, VGPR, CR, sCR., From enrollment to best response; approximately 5 months after initiating nivolumab|Duration of Response (DoR), Duration of best response will be calculated for each participant. The duration of best response interval will begin at the first disease assessment date indicating the participant's best response. The timing for progression, death, or censoring will be determined as previously described for PFS., From date of best response to date of progression or death, or censored as described; assessed for approximately 4 years|Minimal Residual Disease (MRD) Negativity Rate, MRD response will be determined for each participant as a binary variable indicating if the participant achieved a MRD negative status after treatment with nivolumab. MRD negative status will be separately determined at 10-5 and 10-6 sensitivity., approximately 2 months and 5 months after enrollment|Overall Survival, OS is defined as the duration of time from ide-cel administration to the date of death from any cause. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive., From date of ide-cel administration to date of death, or censored as described; assessed for approximately 4 years
Other Outcome Measures: Number of participants with a grade 3 or higher cytokine release syndrome event, A binary variable will be determined for each participant indicating whether or not the participant experienced Grade 3 or higher treatment-emergent (regardless of causality) cytokine release syndrome (CRS) per TCT Consensus Grading during study treatment (from first dose of nivolumab until 100 days after the last dose of nivolumab)., From enrollment to 100 days after the last dose of nivolumab|Number of participants with a grade 3 or higher infection, A binary variable will be determined for each participant indicating whether or not the participant experienced a Grade 3 or higher treatment-emergent (regardless of causality) infection, according to the NCI Common Terminology for Adverse Events version 5.0 during study treatment (from first dose of nivolumab until 100 days after the last dose of nivolumab)., From enrollment to 100 days after the last dose of nivolumab|Number of participants with a grade 3 or higher neurotoxicity event, A binary variable will be determined for each participant indicating whether or not the participant experienced a Grade 3 or higher treatment-emergent (regardless of causality) neurotoxicity event, according to the NCI Common Terminology for Adverse Events version 5.0 during study treatment (from first dose of nivolumab until 100 days after the last dose of nivolumab). Neurotoxicity events will be investigator determined., From enrollment to 100 days after the last dose of nivolumab|Number of participants with a grade 3 or higher immune-related adverse event, A binary variable will be determined for each participant indicating whether or not the participant experienced a Grade 3 or higher treatment-emergent (regardless of causality) immune-related adverse event, according to the NCI Common Terminology for Adverse Events version 5.0 during study treatment (from first dose of nivolumab until 100 days after the last dose of nivolumab). Immune-related events will be confirmed by investigator., From enrollment to 100 days after the last dose of nivolumab|Number of participants with a grade 4, treatment-related non-hematologic adverse event, A binary variable will be determined for each participant indicating whether or not the participant experienced a treatment-related Grade 4 non-hematologic adverse event, according to the NCI Common Terminology for Adverse Events version 5.0 during study treatment (from first dose of nivolumab until 100 days after the last dose of nivolumab)., From enrollment to 100 days after the last dose of nivolumab|Number of participants with an on-treatment grade 5 adverse event, A binary variable will be determined for each subject indicating whether or not the subject experienced a grade 5 adverse event, regardless of causality, according to the NCI Common Terminology for Adverse Events version 5.0 during study treatment (from first dose of nivolumab until 100 days after the last dose of nivolumab)., From enrollment to 100 days after the last dose of nivolumab|Number of participants with at least one serious adverse event, A binary variable will be determined for each participant indicating whether or not the subject had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infectious agent via medial product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring., From enrollment until 100 days after last dose of study treatment|Number of participants with at least one treatment emergent adverse event, A binary variable will be determined for each participant indicating whether or not the subject had at least one treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 5.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start., From enrollment until 100 days after last dose of study treatment|Number of participants with at least one grade 3 or higher treatment emergent adverse event, A binary variable will be determined for each participant indicating whether or not the subject had at least one grade 3 or higher treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 5.0. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start., From enrollment until 100 days after last dose of study treatment|Number of participants who discontinued study treatment due to adverse events, A binary variable will be determined for each participant indicating whether or not the subject discontinued study treatment due to adverse events., From enrollment until 100 days after last dose of study treatment