OncoPep has begun a Phase lb clinical trial to investigate the safety and tolerability of PVX-410 vaccine in two different combinations for the treatment of patients with smoldering multiple myeloma (SMM).

The open-label investigator-sponsored trial is expected to evaluate PVX-410 in combination with an investigational histone deacetylase (HDAC 6) inhibitor, citarinostat (CC96241, Celgene).

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PVX-410 will also be evaluated in a triple combination of PVX-410, citarinostat, and lenalidomide during the trial, which is led by Massachusetts General Hospital Cancer Center’s Center for Multiple Myeloma director Dr Noopur Raje.

The trial intends to enrol around 20 patients at various sites, including Massachusetts General Hospital.

The primary endpoint of the trial is safety and tolerability, while the trial’s secondary endpoints include immune responses of lymphocytes to human leucocyte antigen (HLA) A2+ (HLA A2+), change in monoclonal (M) serum protein, change in free light chain (FLC), among others.

“Currently, there are no active treatment options for smoldering multiple myeloma and standard care for patients diagnosed with SMM is ‘watchful waiting’.”

Raje said: “Currently, there are no active treatment options for smoldering multiple myeloma and standard care for patients diagnosed with SMM is ‘watchful waiting’.

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“This Phase lb clinical trial will further evaluate the safety and tolerability of PVX-410 in combination with the HDAC 6 inhibitor, citarinostat, with or without the immunomodulatory drug, lenalidomide, in hopes that the combination will supplement a targeted immune-mediated attack against MM cells.”

SMM, a plasma cell proliferative disorder with a high risk of progression to multiple myeloma (MM), is estimated to account for nearly 15% of all newly diagnosed cases of MM.

The annual risk of progression from SMM to symptomatic MM that needs treatment is estimated to be 10%.