Dendritic Cell DKK1 Vaccine for Monoclonal Gammopathy and Stable or Smoldering Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03591614|
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Monoclonal Gammopathy Smoldering Myeloma Myeloma||Biological: DKK1||Early Phase 1|
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.
- Assess response according to international response criteria (> partial response, PR) and clinical benefit response (>minor response, MR, according to adapted EBMT criteria)
- Determine time to progression
- Describe progression-free and overall survival
- Explore correlation between myeloma DKK1 and PDL-1 expression and response
- Determine cellular immune response
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Dendritic Cell DKK1 Vaccine for Patients With Monoclonal Gammopathy and Stable or Smoldering Myeloma|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: Dendritic cell DKK1 vaccine
5-10x106 DKK1 loaded dendritic cells. Three doses will be given two weeks apart, followed by 11 months of observations.
The investigational agent is a DKK1 peptide-loaded autologous dendritic cell vaccine dispensed at a dose of 5-10x106 in 0.5 mL Plasma-Lyte A + 5% HSA.
- Number of patients with dose limiting toxicity [ Time Frame: Up to 1 year ]Toxicity will be assessed according to CTCAE v.4.03. Patients will have weekly CBC w. Differential, CMP, history, and physical. DLT will be defined as any vaccine related non-hematologic toxicity, neutropenia, anemia or thrombocytopenia > grade 3 that does not resolve to grade < 2 within 7 days.
- Average time of progression-free survival [ Time Frame: Up to 1 year ]Progression-free survival will be measured from administration of the first vaccine dose to progression as defined by updated uniform international response criteria or death of any cause, whichever comes first.
- Average time of overall survival [ Time Frame: Up to 1 year ]Overall survival will be measured from administration of the first vaccine dose to death from any cause.
- Average time to progression [ Time Frame: Up to 1 year ]Time to progression will be measured from administration of the first vaccine dose to progression as defined by updated uniform international response criteria
- Best overall response [ Time Frame: Up to 1 year ]Response will be evaluated according to updated uniform response criteria
- Clinical Benefit Response [ Time Frame: Up to 1 year ]Response will be evaluated according to updated uniform response criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591614
|Contact: Ehsan Malek, MD||1-800-641-2422||CTUReferral@UHhospitals.org|
|Contact: Alex Mejia-Garcia, MD||CancerCenterResearch@ccf.org|
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Ehsan Malek, MD|
|Principal Investigator: Ehsan Malek, MD|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Alex Mejia-Garcia, MD|
|Principal Investigator: Alex Mejia-Garcia, MD|
|Principal Investigator:||Ehsan Malek, MD||University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|