A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM

NCT02886065 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 16-237
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 6

Brief Summary

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:

• Lenalidomide
• Citarinostat (CC-96241)
• PVX-410

Conditions

Smoldering Multiple Myeloma

Keywords

Myeloma

Outcome Measures

Primary Outcomes (1)

• Safety And Tolerability Of The PVX-410 Tumor Vaccine Regimen

  The proportion of participants who experience dose limiting toxicities and other toxicities. The CTCAE version 4 criteria will be used to grade adverse events.

  2 years

Secondary Outcomes (5)

• Immune Responses Of Lymphocytes To HLA A2+

  2 years

• Change In Monoclonal (M) Serum Protein

  2 years

• Change In Free Light Chain (FLC)

  2 years

• Change In Urinary FLC Level

  2 years

• Correlation of Immune Response and Clinical Anti-tumor Responses

  2 years

Study Arms (2)

PVX-410 + Citarinostat

EXPERIMENTAL

Participants will receive: * 6 biweekly doses of PVX-410 * 6 biweekly doses of Hiltonol * 3 monthly cycles of Citarinostat

Drug: Hiltonol; Drug: Citarinostat; Biological: PVX-410

PVX-410 + Citarinostat + Lenalidomide

EXPERIMENTAL

Participants will receive: * 6 biweekly doses of PVX-410 * 6 biweekly doses of Hiltonol * 3 monthly cycles of Citarinostat * 3 monthly cycles of Lenalidomide

Drug: Hiltonol; Drug: Citarinostat; Drug: Lenalidomide; Biological: PVX-410

Interventions

Hiltonol DRUG

Intramuscular injection of Hiltonol (1 mg) administered Biweekly at the time of PVX-410 administration

Also known as: Poly ICLC

PVX-410 + Citarinostat; PVX-410 + Citarinostat + Lenalidomide

Citarinostat DRUG

Citarinostat (180 mg) administered orally once daily on days 1-21 every 28 day cycle.

Also known as: CC-96241

PVX-410 + Citarinostat; PVX-410 + Citarinostat + Lenalidomide

Lenalidomide DRUG

Lenalidomide (25 mg) administered orally once daily on days 1-21 every 28 day cycle.

Also known as: REVLIMID

PVX-410 + Citarinostat + Lenalidomide

PVX-410 BIOLOGICAL

PVX-410 Biweekly (0.8 mg) via subcutaneous injection

PVX-410 + Citarinostat; PVX-410 + Citarinostat + Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has confirmed SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition (International Working Group, 2003): serum M-protein ≥3 g/dL or BMPC \>10%, or both, along with normal organ and marrow function (CRAB) within 4 weeks before baseline.
• C: Absence of hypercalcemia, evidenced by a calcium \<10.5 mg/dL.
• R: Absence of renal failure, evidenced by a creatinine \< 1.5 mg/dL (177 µmol/L) or calculated creatinine clearance (using the Modification of Diet in Renal Disease \[MDRD\] formula) \>50 mL/min.
• A: Absence of anemia, evidenced by a hemoglobin \>10 g/dL.
• B: Absence of lytic bone lesions on standard skeletal survey.
• Patient is at higher than average risk of progression to active MM, defined as having 2 or more of the following features:
• Serum M-protein ≥3 g/dL.
• BMPC \>10%.
• Abnormal serum FLC ratio (0.26-1.65).
• Patient is aged 18 years or older.
• Patient has a life expectancy of greater than 6 months.
• Patient is HLA-A2+
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patient has adequate bone marrow function, evidenced by a platelet count ≥75×109/L and an absolute neutrophil count (ANC) ≥1.0×109/L within 2 weeks before baseline.
• Patient has adequate hepatic function, evidenced by a bilirubin ≤2.0 mg/dL and an alanine transaminase (ALT), and aspartate transaminase (AST) ≤2.5×ULN within 2 weeks before baseline.

You may not qualify if:

• Patient has symptomatic MM, as defined by any of the following:
• Lytic lesions or pathologic fractures.
• Anemia (hemoglobin \<10 g/dL).
• Hypercalcemia (corrected serum calcium \> 11.5 mg/dL).
• Renal insufficiency (creatinine \> 1.5 mg/dL).
• Other: symptomatic hyperviscosity, amyloidosis.
• Patient has a history of a prior malignancy within the past 3 years (excluding resected basal cell carcinoma of the skin or in situ cervical cancer).
• Patient has abnormal cardiac status, evidenced by any of the following:
• New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
• Myocardial infarction within the previous 6 months.
• Symptomatic cardiac arrhythmia requiring treatment or persisting despite treatment.
• Patient is receiving any other investigational agent.
• Patient has a current active infectious disease or positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), or hepatitis A virus (HAV).
• Patient has a history of or current auto-immune disease.
• Patient has been vaccinated with live attenuated vaccines within 4 weeks before study vaccination.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Celgene: collaborator
• OncoPep, Inc.: collaborator

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospital of Cleveland- Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Smoldering Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

poly ICLC; citarinostat; Lenalidomide; PVX-410 vaccine

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Noopur Raje, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 28, 2016
• First Posted: September 1, 2016
• Study Start: March 7, 2017
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)