Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel

NCT06523621 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00118367LCI-PCD-RRMM-NIVO-001Pro00081644
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Plasma Cell Disease; CAR-T

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Progression Free Survival (PFS)

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

• Best Overall Response

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

• Duration of Response (DoR)

  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

  approximately 2 months and 5 months after enrollment

• Overall Survival

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

Other Outcomes (10)

• Number of participants with a grade 3 or higher cytokine release syndrome event

  From enrollment to 100 days after the last dose of nivolumab

• Number of participants with a grade 3 or higher infection

  From enrollment to 100 days after the last dose of nivolumab

• Number of participants with a grade 3 or higher neurotoxicity event

  From enrollment to 100 days after the last dose of nivolumab

Study Arms (1)

Single Arm

EXPERIMENTAL

Nivolumab

Drug: Nivolumab

Interventions

Nivolumab DRUG

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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: 2020\_09\_HMA\_CTFG\_Contraception\_guidance\_Version\_1.1\_updated.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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Atrium Health Levine Cancer Institute: collaborator
• Bristol-Myers Squibb: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Barry A Paul, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: February 28, 2025
• Primary Completion: March 21, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)