A Phase 2 interventional study of Nivolumab in Multiple Myeloma, sponsored by Wake Forest University Health Sciences. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
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.
This is a single arm, two-stage, Phase II of adjuvant nivolumab in patients with RRMM treated with at least 2 prior lines of therapy and are refractory to or intolerant of at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 antibody who achieved a sub-optimal response (defined as a VGPR, PR, MR, or SD by IMWG 2016 criteria) to treatment with idecabtagene vicleucel.
This study will determine best overall response after 2 cycles of adjuvant nivolumab given every 4 weeks in patient who achieve a sub-optimal response to ide-celon restaging studies \~30 days after infusion. The Investigators will also evaluate for changes in CAR-T cell expansion, persistence of CAR-T cells, and additional toxicity compared to historical controls.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 1 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Measurable disease according to IMWG 2016 criteria present within 28 days prior to ide-cel infusion. Note that patients will NOT be required to have measurable disease at time of enrollment. Measurable disease is defined as:
Previous treatment with idecabtagene vicleucel according to the FDA approved US prescribing information with a response of CR/sCR, VGPR or PR by IMWG 2016 criteria evaluated no sooner than 3 weeks after idecabtagene vicleucel infusion when compared to baseline disease evaluations collected no earlier than 28 days prior to ide-cel infusion. Note: The 28-day window applies to all assessments, even if assessments were performed on different days.
Note: Participants who received non-conforming idecabtagene vicleucel who were originally prescribed idecabtagene vicleucel according to the FDA approved label may be considered for inclusion per the investigator's discretion.
Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 72 hours prior to enrollment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of informed consent until 5 months after last dose of nivolumab. Contraceptive methods with low user dependency are preferable but not required (see table, adapted from: 2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf)
Exclusion Criteria:
History of/or active infection listed below:
History of transplant:
Nivolumab
Drug: Nivolumab
2 cycles of nivolumab at a dose of 480 mg given over approximately 30-minutes intravenously on Day 1 of each treatment cycle
Also known as: Opdivo
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.
Time frame: From enrollment to best response; approximately 5 months after initiating nivolumab
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From date of ide-cel administration to date of death, or censored as described; assessed for approximately 4 years
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment until 100 days after last dose of study treatment
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Plan to share: No
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Wake Forest University Health Sciences