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Multiple MyelomaPhase 2NCT06523621

Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel

A Phase 2 study testing Nivolumab in people with Multiple Myeloma, run by Wake Forest University Health Sciences at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
28 Feb 2025to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent and HIPAA authorization for release of personal health information signed by the participant or his/her legally authorized representative
  • Age ≥ 18 years at the time of consent
  • ECOG Performance Status (PS) of ≤ 1 at the time of enrollment. PS must be evaluated within 14 days prior to enrollment.
  • 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:
  • Serum M-protein ≥1 g/dL (> 0.5 g/dL for IgA or IgM) OR
  • Urine M-protein ≥200 mg/24 h OR
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  • Involved free light chain (FLC) level ≥10 mg/dL provided serum FLC ratio is abnormal
  • 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.
  • Participants must be enrolled no sooner than 3 weeks and no later than 6 weeks from the date of the idecabtagene vicleucel infusion.
  • Recovered from all non-hematologic reversible acute toxic effects of prior therapy (other than alopecia) to ≤ grade 1 or baseline. Participants with grade ≤ 2 treatment induced peripheral neuropathy are eligible. Participants with hematologic reversible acute toxic effects are allowed to participate if laboratory values meet eligibility parameters.
  • Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to enrollment. The most recent labs prior to enrollment will be used to evaluate for eligibility if labs drawn more than once during screening.
  • 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: 202009HMACTFGContraceptionguidanceVersion1.1updated.pdf)
  • Ability of the participant to understand and comply with study procedures for the entire length of the study, as determined by the enrolling investigator

Who cannot join

  • Diagnosis of Waldenstrom macroglobulinemia, POEMS syndrome, or amyloidosis
  • History of/or active infection listed below:
  • Active infection requiring systemic therapy (NOTE: at discretion of investigator, participants receiving treatment for an uncomplicated urinary tract infection or localized cellulitis may be eligible.)
  • Uncontrolled Human Immunodeficiency Virus (HIV) or hepatitis B infection. Well controlled HIV infection (as defined by an undetectable viral load) and chronic hepatitis B infection on appropriate prophylaxis can be considered per enrolling investigator discretion
  • Active hepatitis C infection. Participants with previously treated hepatitis C infection with documented eradication of their infection will be allowed to enroll.
  • Known history of active TB (Bacillus Tuberculosis)
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  • Pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on study.)
  • Current evidence of active cytokine release syndrome or neurotoxicity (any grade)
  • Participants previously diagnosed with an additional malignancy must be disease-free for at least 2 years prior to enrollment. Exceptions include basal cell or squamous cell skin cancer and in situ cervical or bladder cancer.
  • Treatment with any anti-myeloma therapy or investigational drug within 30 days prior to cycle 1 day 1 of nivolumab other than ide-cel with the exception of lymphodepleting chemotherapy or steroids for ide-cel therapy. Investigational includes drugs approved for human use but not approved for the indication.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
  • History of transplant:
  • Autologous stem cell transplant within 12 weeks of C1D1
  • Allogeneic stem cell transplant
  • Solid organ transplant
  • Active known or suspected autoimmune disease. Participants with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Known history of interstitial lung disease or known history of non-infectious pneumonitis
  • Inability to take Pneumocystis jirovecii (PJP) prophylaxis (either trimethoprim-sulfamethoxazole, dapsone, or pentamidine)
  • A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of C1D1 (Note: Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease)
  • Prisoners or participants who are involuntarily incarcerated
  • Known history of myocarditis, regardless of etiology
  • Known history of allergy or hypersensitivity to study drug components
  • History of serious side effects to nivolumab or ipilimumab, as defined by the enrolling investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

Other trials in United States

About this study

Official title: Nivolumab As An Adjunctive Therapy In Relapsed Refractory Multiple Myeloma Patients With Sub-Optimal Response To Idecabtagene Vicleucel

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.

Read the detailed description

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.

Being tested
Nivolumab
Keywords
Plasma Cell Disease, CAR-T
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    2 cycles of nivolumab at a dose of 480 mg given over approximately 30-minutes intravenously on Day 1 of each treatment cycle

Study groups in NCT06523621
Study groupRoleWhat they receive
Single ArmExperimentalNivolumab
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to best response; approximately 5 months after initiating nivolumab

Secondary outcomes (5)

  1. 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.

    Measured: From date of ide-cel administration to date of progression or death, or censored as described; assessed for approximately 4 years

  2. 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.

    Measured: From enrollment to best response; approximately 5 months after initiating nivolumab

  3. 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.

    Measured: From date of best response to date of progression or death, or censored as described; assessed for approximately 4 years

  4. 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.

    Measured: approximately 2 months and 5 months after enrollment

  5. 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.

    Measured: From date of ide-cel administration to date of death, or censored as described; assessed for approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start28 Feb 2025
  3. Primary completion21 Mar 2026
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06523621
Sponsor's protocol ID
IRB00118367
Other IDs
LCI-PCD-RRMM-NIVO-001, Pro00081644
Status last verified
Jul 2026
First submitted
22 Jul 2024
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Multiple Myeloma, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depth of Response (time frame: From enrollment to best response; approximately 5 months after initiating nivolumab). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06523621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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