A Study of two investigational drugs including PVX-410 (a Multi-Peptide Cancer Vaccine), and Citarinostat (a Histone Deacetylase Inhibitor (HDAC)) +/- Lenalidomide for Patients with Moderate or High Risk of Progression Smoldering Multiple Myeloma

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Overview

This research study is a phase I clinical trial primarily evaluating the safety of an immunotherapy as a possible treatment for patients with moderate/high risk Smoldering Multiple Myeloma. The study will also be evaluating the appropriate dosing regimen as well as the clinical response and patient’s immune response to the study drugs involved.

The study will test two different combinations of the study drugs; a combination of the vaccine (PVX-410) along with Citarinostat (CC-96241) and a triple combination of the vaccine, Citarinostat, and Lenalidomide.

There are two experimental arms to this study. One arm is evaluating the combination of PVX-410 and Citarinostat. The other arm is a triplet combination evaluation of PVX-410 with Citarinostat and Lenalidomide.

This is a non-randomized study so you will know which arm you would be participating in if you are eligible for the study.

Experimental Arm 1: PVX-410 + Citarinostat

  • 6 biweekly doses of PVX-410 - (0.8 mg/peptides) via subcutaneous injection
  • 6 biweekly doses of Hiltonol - (1 mg) Intramuscular injection given at the time of PVX-410 administration (this drug is administered as an adjuvant to PVX-410 to help boost the patient’s immune response to the vaccine)
  • 3 monthly cycles of Citarinostat - (180 mg) administered orally once daily on days 1-21 every 28 day cycle
  • This will be followed by a dose of PVX-410 at month 1, 2, 3, 6, and 9 follow-up visits

Experimental Arm 2: PVX-410 + Citarinostat + Lenalidomide

  • 6 biweekly doses of PVX-410 - (0.8 mg) via subcutaneous injection
  • 6 biweekly doses of Hiltonol - (1 mg) Intramuscular injection given at the time of PVX-410 administration
  • 3 monthly cycles of Citarinostat - (180 mg) administered orally once daily on days 1-21 every 28 day cycle
  • 3 monthly cycles of Lenalidomide - (25 mg) administered orally once daily on days 1-21 every 28 day cycle
  • This will be followed by a dose of PVX-410 at month 1, 2, 3, 6, and 9 follow-up visits

How long will I be in the study?

If you qualify and choose to participate, your total length of time in the study, including the screening, dosing period(s), and follow-up periods, will be about 16 months.

This study includes four periods:

  • Screening:The screening period, begins after you sign the informed consent form. It includes an exam and lab tests as well as tissue typing to evaluate whether or not you qualify for the clinical trial. The screening period may last about 28 days and will end with notification of whether or not you are qualified for the clinical trial.
  • Treatment:If you are accepted into the trial and choose to participate, you will be treated with the study drug. Detailed information about the duration, dosing and testing procedures during the treatment period and end of treatment visit will be explained by the study doctor.
  • Follow-up:following the end of active treatment you will have an additional visit with your doctor.
SparkCures ID 835
Trial Phase Phase 1
Enrollment 20 Patients
Treatments
Trial Sponsors
  • Massachusetts General Hospital
Trial Collaborators
  • Celgene Corporation
  • OncoPep, Inc.
NCT Identifier

NCT02886065

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

You may be eligible to participate in this study if you:

  • Are at least 18 years old.
  • Have smoldering multiple myeloma
  • Are at higher than average risk of progression to active multiple myeloma (classified as having more than 2 risk factors)
  • Has a life expectancy of greater than 6 months
  • Are HLA-A2+ (HLA testing is a way to determine your tissue type. Every patient has a tissue type. You need to be A2+ to participate in this study)
  • Cannot have received previous treatment with a HDAC inhibitor, including Citarinostat

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • 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.
  • 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.
  • If assigned to receive lenalidomide and a female of reproductive potential, must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • If assigned to receive lenalidomide, patient must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.
  • Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  • 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.
  • Any previous treatment with a HDAC inhibitor, including Citarinostat.
  • Had involvement in the planning and/or conduct of the study by association with the Sponsor, study drug supplier(s) or study center or was previously enrolled in the present study.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
  • Known history of previous clinical diagnosis of tuberculosis.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Massachusetts General Hospital
Dana-Farber Cancer Institute
University Hospitals<br />Seidman Cancer Center at UH Case Medical
University Hospitals
Seidman Cancer Center at UH Case Medical

Cleveland, OH

Massachusetts
Massachusetts General Hospital
Dana-Farber Cancer Institute
Ohio
University Hospitals<br />Seidman Cancer Center at UH Case Medical
University Hospitals
Seidman Cancer Center at UH Case Medical

Cleveland, OH

Resources

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