Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
A Phase 1/2a Dose Escalation Study of PVX-410, a Multi-Peptide Cancer Vaccine, in Patients With Smoldering Multiple Myeloma
1 other identifier
interventional
22
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2012
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 28, 2016
September 1, 2016
3.6 years
October 29, 2012
September 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
All adverse events will be recorded.
Throughout treatment phase (3 months) and follow up period (12 months)
Secondary Outcomes (1)
Immune response to the vaccine will be measured
Designated timepoints during the treatment phase (3 months) and follow up phase (12 months)
Other Outcomes (1)
Clinical Response will be measured.
Designated timepoints during the treatment phase (3 months) and follow up phase (12 months)
Study Arms (3)
PVX-410, .4 mg dose
EXPERIMENTALApproximately 3 patients will receive 6, bi-weekly, subcutaneous injections of a .4 mg 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.
PVX-410, .8 mg dose
EXPERIMENTALApproximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg 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.
PVX-410 plus lenalidomide
EXPERIMENTALApproximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will also receive 3 cycles of lenalidomide. Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
Interventions
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
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OncoPep, Inc.lead
Study Sites (6)
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Nooka AK, Wang ML, Yee AJ, Kaufman JL, Bae J, Peterkin D, Richardson PG, Raje NS. Assessment of Safety and Immunogenicity of PVX-410 Vaccine With or Without Lenalidomide in Patients With Smoldering Multiple Myeloma: A Nonrandomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e183267. doi: 10.1001/jamaoncol.2018.3267. Epub 2018 Dec 13.
PMID: 30128502DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noopur Raje, MD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Michael Wang, MD
M.D. Anderson Cancer Center
- PRINCIPAL INVESTIGATOR
Ajay Nooka, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2012
First Posted
October 31, 2012
Study Start
November 1, 2012
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
September 28, 2016
Record last verified: 2016-09