Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01718899
Other study ID # 2010-001
Secondary ID
Status Completed
Phase Phase 1
First received October 29, 2012
Last updated September 26, 2016
Start date November 2012
Est. completion date September 2016

Study information

Verified date September 2016
Source OncoPep, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.


Description:

This is a dose escalation, phase 1/2a study to assess the safety and tolerability of PVX-410, (a multi-peptide cancer vaccine), treatment regimen in patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.. Approximately 22 patients will receive six (6) bi-weekly, subcutaneous injections of PVX-410 for a total of twelve (12) weeks of treatment. Safety will be monitored throughout the study. Tolerability, immunogenicity and clinical response will also be measured as described in the protocol.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility - Patient has confirmed clinical diagnosis of SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition: serum M-protein =3 g/dL or bone marrow clonal plasma cells (BMPC) greater than or equal to 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 <2.0 mg/dL 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 monoclonal (M)-protein =3 g/dL.

- BMPC greater than or equal to 10%.

- Abnormal serum free light chain (FLC) ratio (0.26-1.65).

- Patient has a life expectancy of greater than 6 months

- Patient is human leukocyte antigen (HLA)-A2 positive.

- 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× the upper limit of normal (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 urine pregnancy test results within 2 weeks before baseline and is not lactating.

- Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study.

Exclusion Criteria:

- Patient has symptomatic multiple myeloma, 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 >2 mg/dL).

- Other: symptomatic hyperviscosity, amyloidosis.

- 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), or hepatitis B virus (HBV).

- Patient has a history of or current auto-immune disease.

- Patient has been vaccinated with live attenuated vaccines within 4 weeks before study vaccination.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
PVX-410
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months

Locations

Country Name City State
United States Winship Cancer Institute, Emory University Atlanta Georgia
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Texas, MD Anderson Cancer Center Houston Texas
United States Illinois Cancer Specialists Niles Illinois

Sponsors (1)

Lead Sponsor Collaborator
OncoPep, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Clinical Response will be measured. Clinical response will be determined by the treating physician according to the International Myeloma Working Group Disease Response Criteria. Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) No
Primary All adverse events will be recorded. Throughout treatment phase (3 months) and follow up period (12 months) Yes
Secondary Immune response to the vaccine will be measured Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays. Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) No
See also
  Status Clinical Trial Phase
Completed NCT01222286 - Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma Phase 2
Withdrawn NCT00503763 - Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma Phase 2
Active, not recruiting NCT02916771 - Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma Phase 2
Completed NCT01955395 - Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma N/A
Completed NCT01237054 - Imaging in MGUS, SMM and MM Phase 2
Completed NCT02903381 - A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma Phase 2
Active, not recruiting NCT03301220 - A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma Phase 3
Active, not recruiting NCT03236428 - Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma Phase 2
Completed NCT00099047 - Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma Phase 2
Completed NCT00112827 - Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma Phase 1/Phase 2
Terminated NCT01248455 - A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma Phase 2
Active, not recruiting NCT03289299 - Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant Phase 2
Not yet recruiting NCT06365060 - Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Active, not recruiting NCT02415413 - Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma Phase 2
Completed NCT01302886 - Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma Phase 2
Recruiting NCT05841550 - The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma Phase 1/Phase 2
Recruiting NCT06183489 - Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma Phase 2
Recruiting NCT06383143 - Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
Active, not recruiting NCT02886065 - A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM Phase 1
Withdrawn NCT01571726 - Imaging Studies and the Development of Multiple Myeloma Phase 2