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NCT03782064

Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma

Terminated Phase 2 Results posted Last updated 22 June 2023
What this trial tests

Phase 2 trial testing Nivolumab in Multiple Myeloma in 5 participants. Terminated before completion.

Timeline
22 February 2019
Primary endpoint
31 January 2021
31 January 2021

Quick facts

Lead sponsorBeth Israel Deaconess Medical Center
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date22 February 2019
Primary completion31 January 2021
Estimated completion31 January 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Beth Israel Deaconess Medical Center

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Who Develop Immunologic Response to Nivolumab and the DC/MM Fusion Vaccine Primary · 2 years

We planned to evaluate the immunologic response to treatment in blood and bone marrow. Two patients were treated on protocol and both came off due to disease progression early in the course of therapy (one patient during cycle 1 and one patient during cycle 3.) As such, there is insufficient data to perform what had been planned in correlative science studies so no samples were analyzed. This study has been stopped and no further patients are being enrolled and no further samples are being collected. No data has been obtained for any immune analysis; therefore no immune or clinical data will b

GroupValue95% CI
Nivolumab+DC/Myeloma Fusions/GM-CSF0
Number of Patients Who Achieve a Clinical Response (SD, PR, VGPR, CR) Secondary · 2 years

We looked at the two patients who were treated and evaluated their response to treatment.

GroupValue95% CI
Nivolumab+DC/Myeloma Fusions/GM-CSF0
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Secondary · 2 years

We evaluated the number of patients who developed a related adverse event as assessed by the CTCAE version 4.0.

GroupValue95% CI
Nivolumab+DC/Myeloma Fusions/GM-CSF2
Number of Patients Who Are Alive Without Progression at 2 Years Secondary · 2 years

We calculated the number of patients who were alive without progression at 2 years

GroupValue95% CI
Nivolumab+DC/Myeloma Fusions/GM-CSF0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from the first dose of treatment through 30 days after the last dose of treatment up to 6 months. All-Cause Mortality monitored/assessed up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nivolumab+DC/Myeloma Fusions/GM-CSF
Serious: 1/2 (50%)
Deaths: 2/2

Serious adverse events (1 terms)

ReactionSystemNivolumab+DC/Myeloma Fusio…
Rash, maculopapularSkin and subcutaneous tissue disorders
Other adverse events (6 terms — click to expand)

ReactionSystemNivolumab+DC/Myeloma Fusio…
Injection Site ReactionGeneral disorders
Alkaline Phosphatase IncreaseInvestigations
GGT increasedInvestigations
AnemiaBlood and lymphatic system disorders
Muscle Weakness (lower limb)Musculoskeletal and connective tissue disorders
Pain, hipMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Rash, maculopapular.

Data from ClinicalTrials.gov NCT03782064 adverse events section.

Sponsor's own description

This research study is studying a cancer vaccine called Dendritic Cell/MM Fusion vaccine (DC/MM vaccine) in combination with nivolumab, as a possible treatment for multiple myeloma (MM). The drugs involved in this study are: * Dendritic Cell/MM Fusion vaccine (DC/MM vaccine) * Nivolumab, an immunotherapy drug

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Trial watch: dendritic cell vaccination for cancer immunotherapy.
    Sprooten J, Ceusters J, Coosemans A, Agostinis P, et al · · 2019 · cited 107× · PMID 31646087 · DOI 10.1080/2162402x.2019.1638212
  2. Trial watch: Dendritic cell (DC)-based immunotherapy for cancer.
    Laureano RS, Sprooten J, Vanmeerbeerk I, Borras DM, et al · · 2022 · cited 101× · PMID 35800158 · DOI 10.1080/2162402x.2022.2096363
  3. Dendritic Cell-Based Immunotherapy in Multiple Myeloma: Challenges, Opportunities, and Future Directions.
    Verheye E, Bravo Melgar J, Deschoemaeker S, Raes G, et al · · 2022 · cited 38× · PMID 35055096 · DOI 10.3390/ijms23020904
  4. Personal tumor antigens in blood malignancies: genomics-directed identification and targeting.
    Penter L, Wu CJ. · · 2020 · cited 13× · PMID 31985488 · DOI 10.1172/jci129209
  5. Insights and Strategies of Melanoma Immunotherapy: Predictive Biomarkers of Response and Resistance and Strategies to Improve Response Rates.
    Seyhan AA, Carini C. · · 2022 · cited 12× · PMID 36613491 · DOI 10.3390/ijms24010041
  6. The emerging role of dendritic cells in the tumor microenvironment: from antigen presentation to targeted immunotherapy.
    Xie Z, Fang Y, Zhang X, Fang Y, et al · · 2025 · cited 5× · PMID 41430039 · DOI 10.1038/s41419-025-08180-0
  7. Breaking barriers: Smart vaccine platforms for cancer immunomodulation.
    Gomari MM, Ghantabpour T, Pourgholam N, Rostami N, et al · · 2025 · cited 5× · PMID 39901621 · DOI 10.1002/cac2.70002
  8. Research and Clinical Progress of Therapeutic Tumor Vaccines.
    Dong C, Li Z, Tan D, Sun H, et al · · 2025 · cited 3× · PMID 40733649 · DOI 10.3390/vaccines13070672

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Beth Israel Deaconess Medical Center trials

Trials by the same sponsor.

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