Smoldering Multiple MyelomaPhase 1NCT02886065
A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM
A Phase 1 study testing Hiltonol, Citarinostat and Lenalidomide in people with Smoldering Multiple Myeloma, run by Massachusetts General Hospital at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoldering Multiple Myeloma
- What is being tested?
- Hiltonol, Citarinostat and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Mar 2017to 15 Feb 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University Hospital of Cleveland- Seidman Cancer Center
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
Weill Cornell Medical College
New York, New York, 10065
About this study
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
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
Read the 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.
- Conditions
- Smoldering Multiple Myeloma
- Being tested
- Hiltonol, Citarinostat, Lenalidomide, PVX-410
- Keywords
- Myeloma
- Medical subject headings
- Smoldering Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiltonolDrug
Also called Poly ICLC
Intramuscular injection of Hiltonol (1 mg) administered Biweekly at the time of PVX-410 administration
CitarinostatDrug
Also called CC-96241
Citarinostat (180 mg) administered orally once daily on days 1-21 every 28 day cycle.
LenalidomideDrug
Also called REVLIMID
Lenalidomide (25 mg) administered orally once daily on days 1-21 every 28 day cycle.
PVX-410Biological
PVX-410 Biweekly (0.8 mg) via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| PVX-410 + Citarinostat | Experimental | Participants will receive:
* 6 biweekly doses of PVX-410
* 6 biweekly doses of Hiltonol
* 3 monthly cycles of Citarinostat Receives: 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 Receives: Drug: Hiltonol; Drug: Citarinostat; Drug: Lenalidomide; Biological: PVX-410 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Immune Responses Of Lymphocytes To HLA A2+
Measured: 2 years
Change In Monoclonal (M) Serum Protein
Measured: 2 years
Change In Free Light Chain (FLC)
Measured: 2 years
Change In Urinary FLC Level
Measured: 2 years
Correlation of Immune Response and Clinical Anti-tumor Responses
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start7 Mar 2017
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoldering Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene, OncoPep, Inc.
- Responsible party
- Principal investigator, Noopur Raje, Massachusetts General Hospital
- Investigators
- Noopur Raje, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886065
- Sponsor's protocol ID
- 16-237
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2016
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No