A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
David Avigan
Study ID
NCT06799026
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    Bispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.
  • GM-CSF — BIOLOGICAL
    Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.
  • DC/MM Fusion Vaccine — BIOLOGICAL
    Dendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.

Study Details

This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM). The names of the study drugs and vaccine involved in this study are: * DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells) * Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor) * Elranatamab (a type of T-cell engager antibody)

Key Dates

Start date
Jan 31, 2025
Status verified
May 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Elranatamab + DC/MM Vaccine + GM-CSF
    * Baseline visit and assessments * Leukapheresis * Cycle 1 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 2 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycles 3 through 5 (28-day cycles): * Bone marrow biopsy/aspiration prior to first DC/MM fusion vaccine * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Day 8: Predetermined doses of DC/MM fusion vaccine 1x daily and GM-CSF 1x daily (GM-CSF for days 9 through 11 are self-administered) * Cycle 6 (28-day cycle): * Bone marrow biopsy/aspiration on Cycles 6, 9, and 12 * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 7 through 12 (28-day cycles): * Cycle 7 Day 1 only: Bone marrow biopsy/aspiration * Days 1 and 15: Predetermined dose of Elranatamab 1x daily * After end of treatment, bone marrow biopsy/aspiration at months 1, 3, and 6 * 6 month follow up visit * Long term follow up 5 years

Primary Outcome Measure

Administration of DC/MM Vaccine [ Time Frame: 1 Year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
David Avigan, MD
[email protected]
617-667-9920
Emma Logan, MSN
[email protected]
617667-9920
David Avigan, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
David Avigan, MD
[email protected]
617-667-9920
David Avigan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MA

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