NCT03631043

Personalized Vaccine in Treating Patients With Smoldering Multiple Myeloma

A Personalized Vaccine for the Immune Prevention of Multiple Myeloma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial studies the side effects of personalized vaccine in treating patients with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To demonstrate that developing a custom vaccine for smoldering multiple myeloma (SMM) is feasible. II. To show that a custom peptide-based vaccine in smoldering multiple myeloma is safe. SECONDARY OBJECTIVES: I. To determine the intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine. II. Time to progression to multiple myeloma (TTM) at the end of the follow up period (18 months). III. Duration of response. IV. Clinical benefit rate (minor response \[MR\] or better) after 6 cycles of vaccine treatment per modified International Myeloma Working Group (IMWG) criteria for multiple myeloma (MM). V. Overall survival. EXPLORATORY OBJECTIVES: I. Rate of minimal residual disease (MRD) negativity at complete remission (CR), if achieved. MRD assessment will be based on bone marrow aspirates. II. Molecular profiling (including whole exome sequencing, gene expression profiling and ribonucleic acid (RNA) sequencing of tumor/bone marrow samples) and cellular (including flow cytometry) profiling at baseline using bone marrow aspirate samples and peripheral blood. III. Immunophenotypic characterization of dendritic, T-, B-, natural killer (NK)- and NKT-cells, and inhibitory/activation markers on tumor cells at baseline (bone marrow and peripheral blood), day 1 of each cycle (peripheral blood only) and at completion of 6 cycles of therapy (bone marrow and peripheral blood) in bone marrow aspirate samples and/or peripheral blood. IV. Perform mass spectrometry-based proteomics analysis on 15 myeloma cell lines to identify shared human leukocyte antigen (HLA) class I-restricted antigens that can be targeted with immunotherapy. OUTLINE: Patients are assigned to 1 of 2 stages. STAGE I: Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine subcutaneously (SC) on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. STAGE II: Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Patients also receive lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 12 months.

Conditions

• Smoldering Plasma Cell Myeloma

Interventions

Type	Name	Description
PROCEDURE	Biopsy Specimen Radiography	Undergo collection of blood and bone marrow
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Vaccine Therapy	Given personalized vaccine SC

Timeline

• Start date: 2018-12-21
• Primary completion: 2025-12-10
• Completion: 2025-12-10
• First posted: 2018-08-15
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study