A Study of PVX-410, a Cancer Vaccine, and Durvalumab +/- Lenalidomide for Smoldering MM
This research study is studying a targeted therapy as a possible treatment for Smoldering Multiple Myeloma.
The following intervention will be involved in this study:
|Smoldering Multiple Myeloma||Drug: Hiltonol Drug: Durvalumab Drug: Lenalidomide Biological: PVX-410||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||A Phase 1b Study of PVX-410, a Multi-Peptide Cancer Vaccine, and Durvalumab (Anti-PDL1) With and Without Lenalidomide for Patients With Smoldering Multiple Myeloma|
- Determine The Safety And Tolerability Of The PVX-410 [ Time Frame: 2 years ]The CTCAE version 4.03 criteria will be used to grade toxicity
- Immune Responses Of Lymphocytes To HLA A2+ [ Time Frame: 2 years ]
- Change In Monoclonal (M) Serum Protein [ Time Frame: 2 years ]
- Change In Free Light Chain (FLC) [ Time Frame: 2 years ]
- Change In Urinary FLC Level [ Time Frame: 2 years ]
|Study Start Date:||November 2016|
|Estimated Study Completion Date:||September 2021|
|Estimated Primary Completion Date:||September 2019 (Final data collection date for primary outcome measure)|
Experimental: Durvalumab Alone
Patients will receive 3 monthly infusions of Durvalumab
Other Name: Poly ICLCDrug: Durvalumab Biological: PVX-410
Experimental: PVX-410+Durvalumab +Lenalidomide
Other Name: Poly ICLCDrug: Durvalumab Drug: Lenalidomide
Other Name: REVLIMIDBiological: PVX-410
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
In this research study, the investigators are studying Smoldering Multiple Myeloma. Smoldering Multiple Myeloma is an early precursor to a rare blood cancer known as Multiple Myeloma, which affects plasma cells.
The vaccine in Combination with Lenalidomide is being used to hopefully provide immunity against Myeloma. Durvalumab is a check point inhibitor which is being combined here to further augment the immune activity of the vaccine. It is a monoclonal antibody known to take the brakes off the immune system to restore immunity. Lenalidomide in previously studied trials has demonstrated an increase in immune activity. It is the hope of the investigators the combination of the vaccine, Lenalidomide, and Durvalumab will augment immunity even further.
The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 as a treatment for any disease.Durvalumab is also not approved for the treatment of Multiple Myeloma.
The FDA (the U.S. Food and Drug Administration) has approved Lenalidomide as a treatment option for Smoldering Multiple Myeloma
Please refer to this study by its ClinicalTrials.gov identifier: NCT02886065
|Contact: Noopur Raje, MD||617-726-0711|
|United States, Massachusetts|
|Massachusetts general Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Noopur Raje, MD 617-726-0711|
|Principal Investigator: Noopur Raje, MD|
|Principal Investigator:||Noopur Raje, MD||Massachusetts General Hospital|