About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

370533 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

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

Clinicaltrials.gov identifier NCT02886065

Recruitment Status Recruiting

First Posted September 1, 2016

Last update posted August 13, 2019

Study Description

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

  • Condition or Disease:Smoldering Multiple Myeloma
  • Intervention/Treatment: Drug: Hiltonol
    Drug: Citarinostat
    Drug: Lenalidomide
    Biological: PVX-410
  • Phase: Phase 1
Detailed Description

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 study will test two different combinations of the study drugs; a combination of the vaccine (PVX-410) along with Citarinostat (CC-96241) and triple combination of the vaccine, Citarinostat, and Lenalidomide. The vaccine (PVX-410) is a multi-peptide vaccine that contains four synthetic peptides that together are intended to induce a T cell-mediated immune response against the myeloma. The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 as a treatment for any disease. Citarinostat is an orally active, small-molecule Histone Deacetylase (HDAC) Inhibitor which is being combined here to further augment the immune activity of the vaccine. Citarinostat has not been approved by the FDA as a treatment for any disease. Lenalidomide is commercially available analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties that has demonstrated an increase in immune activity in previous trials. The FDA has approved Lenalidomide as a treatment option for Smoldering Multiple Myeloma. Lenalidomide is being added to the combination of the vaccine and Citarinostat because it is hypothesized that co-administration of lenalidomide along with Citarinostat would further enhance the T cell-mediated immune response induced by PVX-410.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • 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 Citarinostat (CC-96241), a Histone Deacetylase Inhibitor (HDAC) With and Without Lenalidomide for Patients With Smoldering Multiple Myeloma
  • Study Start Date: November 2016
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
Experimental: PVX-410 + Citarinostat
Participants will receive: 6 biweekly doses of PVX-410 6 biweekly doses of Hiltonol 3 monthly cycles of Citarinostat
Drug: Hiltonol
Intramuscular injection of Hiltonol (1 mg) administered Biweekly at the time of PVX-410 administration

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

Biological: PVX-410
PVX-410 Biweekly (0.8 mg) via subcutaneous injection
Experimental: PVX-410 + Citarinostat + Lenalidomide
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
Intramuscular injection of Hiltonol (1 mg) administered Biweekly at the time of PVX-410 administration

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

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

Biological: PVX-410
PVX-410 Biweekly (0.8 mg) via subcutaneous injection
Outcome Measures
  • Primary Outcome Measures: 1. Safety And Tolerability Of The PVX-410 Tumor Vaccine Regimen [ Time Frame: 2 years ]
    The proportion of participants who experience dose limiting toxicities and other toxicities. The CTCAE version 4 criteria will be used to grade adverse events.
  • Secondary Outcome Measures: 1. Immune Responses Of Lymphocytes To HLA A2+ [ Time Frame: 2 years ]
  • 2. Change In Monoclonal (M) Serum Protein [ Time Frame: 2 years ]
  • 3. Change In Free Light Chain (FLC) [ Time Frame: 2 years ]
  • 4. Change In Urinary FLC Level [ Time Frame: 2 years ]
  • 5. Correlation of Immune Response and Clinical Anti-tumor Responses [ Time Frame: 2 years ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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 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 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.

Contacts and Locations
Contacts

Contact: Noopur Raje, MD 617-726-0711

Locations

United States, Massachusetts
Massachusetts general Hospital
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Massachusetts
Dana-Farber Cancer Institute
Boston

United States, Ohio
University Hospital of Cleveland- Seidman Cancer Center
Cleveland

Sponsors and Collaborators

Massachusetts General Hospital

Celgene

OncoPep, Inc.

Investigators

Principal Investigator: Noopur Raje, MD Massachusetts General Hospital

More Information
  • Responsible Party: Massachusetts General Hospital
  • ClinicalTrials.gov Identifier: NCT02886065 History of Changes
  • Other Study ID Numbers: 16-237
  • First Posted: September 1, 2016 Key Record Dates
  • Last Update Posted: August 13, 2019
  • Last Verified: August 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Keywords provided by Massachusetts General Hospital: Myeloma
  • Additional relevant MeSH terms: Multiple Myeloma
    Neoplasms, Plasma Cell
    Smoldering Multiple Myeloma