Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03591614
Status:
WITHDRAWN
Last Update Posted:
2023-08-18
First Post:
2018-07-09
Brief Title:
Dendritic Cell DKK1 Vaccine for Monoclonal Gammopathy and Stable or Smoldering Myeloma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study of Dendritic Cell DKK1 Vaccine for Patients With Monoclonal Gammopathy and Stable or Smoldering Myeloma
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to study the safety and preliminary efficacy of a dendritic cell DKK1 vaccine against myeloma Dendritic cells are immune cells that are collected from the blood of the patient at Case Western Reserve Medical Center and then brought into contact with DKK1 a molecule that is present of myeloma cells but not to a significant amount on other cells except for the prostate and the placenta It is an investigational experimental vaccine that based on studies in the laboratory and in mice is expected to work by presentation of DKK1 to anticancer immune cells via dendritic cells leading to an immune attack on myeloma cells It is experimental because it is not approved by the Food and Drug Administration FDA
Detailed Description:
The overall objective of this pilot study is to determine the safety and preliminary efficacy of a dendritic cell DKK1 vaccine in view of possible future use as a strategy to prevent progression of asymptomatic plasma cell disorders maintain disease control and ultimately contribute to eradication of multiple myeloma light and heavy chain amyloidosis immunoglobulin deposition disease and other malignant and non-malignant diseases related to transformed plasma cells
Primary Objective Confirm the safety of dendritic cell DKK1 vaccine given every two weeks for three doses in patients with monoclonal gammopathy stable or smoldering myeloma
Secondary Objectives
1 Assess response according to international response criteria partial response PR and clinical benefit response minor response MR according to adapted EBMT criteria
2 Determine time to progression
3 Describe progression-free and overall survival
Correlative Objectives
1 Explore correlation between myeloma DKK1 and PDL-1 expression and response
2 Determine cellular immune response
3 Assess serologic anti-DKK1 antibody response
Study design including dose escalation cohorts Pilot study with 3 patient safety run-in possible dose level -1 DL-1 if dose limiting toxicity occurs in one or more patients at the target dose level and at the first dose level where no dose limiting toxicity occurs extension by 12 patients
DLT will be defined as any vaccine related toxicity grade 3 that does not resolve to grade 2 within 7 days If any DLT occurs at DL-1 enrollment will be stopped and an amendment will be discussed
Primary Objective Confirm the safety of dendritic cell DKK1 vaccine given every two weeks for three doses in patients with monoclonal gammopathy stable or smoldering myeloma
Secondary Objectives
1 Assess response according to international response criteria partial response PR and clinical benefit response minor response MR according to adapted EBMT criteria
2 Determine time to progression
3 Describe progression-free and overall survival
Correlative Objectives
1 Explore correlation between myeloma DKK1 and PDL-1 expression and response
2 Determine cellular immune response
3 Assess serologic anti-DKK1 antibody response
Study design including dose escalation cohorts Pilot study with 3 patient safety run-in possible dose level -1 DL-1 if dose limiting toxicity occurs in one or more patients at the target dose level and at the first dose level where no dose limiting toxicity occurs extension by 12 patients
DLT will be defined as any vaccine related toxicity grade 3 that does not resolve to grade 2 within 7 days If any DLT occurs at DL-1 enrollment will be stopped and an amendment will be discussed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None