A Phase 1b Study of PVX-410, a Multi-Peptide Cancer Vaccine, and Citarinostat (CC-96241), a Histone Deacetylase Inhibitor (HDAC) with and without Lenalidomide for Patients with Smoldering Multiple Myeloma

Clinical Trial Details

In this research study, we 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. This type of cancer produces certain proteins that can be measures in both blood and urine. These proteins show up before an individual begins to have any symptoms of cancer.

The multi-peptide vaccine, PVX-410, combined with Lenalidomide, an immunomodulatory drug that promotes immune responses to help slow tumor growth, has been previously studied and demonstrated an increase in immune activity. In this study, we will add lenalidomide to the combination of the vaccine and Citarinostat (CC-96241), an oral inhibitor which stops the growth of cancer, with the hope of augmenting immunity even further. Preclinical laboratory data has suggested Citarinostat is able to further augment immunity.

Participants will be randomized into one of the following study groups:

Double Combination Group: Participants will take Citarinostat orally combined with PVX410 injections.
Triple Combination Group: Participants will take Citarinostat orally combined with PVX410 injections and lenalidomide taken orally.

Safety and tolerability will be assessed by documentation of adverse events, including serious adverse events, vaccination injection site examinations, clinical laboratory tests, vital signs, physical examination findings, and performance status assessments.

Participants will be in this research study for approximately 15 months, which includes a follow-up visit after completing the first 12 months of treatment. Participants may choose to withdraw at any time or if the study doctor thinks this treatment is no longer beneficial.

Key Eligibility:

Inclusion Criteria:

Patient has confirmed Smoldering Multiple Myeloma (SMM)
Patient is aged 18 years or older.
Patient has a life expectancy of greater than 6 months.
If of child-bearing potential, patient agrees to use adequate birth control measures during study participation.
If a female of child-bearing potential, patient has negative serum pregnancy test results within 2 weeks before baseline and is not lactating.
Must adhere to the scheduled pregnancy testing.

Exclusion Criteria:

Patient has symptomatic Multiple Myeloma (MM).
Patient has a history of a prior malignancy within the past 3 years.
Patient has abnormal cardiac status, including congestive heart failure (CHF), Myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmia requiring treatment or is persisting despite treatment.
Patient has a history of, or current, auto-immune disease.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, unstable angina pectoris, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness.
Known history of previous clinical diagnosis of tuberculosis.

Detailed eligibility reviewed when contacting the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Natalie Agudo, RN
646-962-5060
naa9101@med.cornell.edu

Primary Investigator(s)

Ruben Niesvizky, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1904020149

ClinicalTrials.gov:

NCT02886065

Status

Open to Enrollment

Age Group

Adult

Disease

Multiple Myeloma

Smoldering Multiple Myeloma