Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
NCT ID: NCT01718899
Last Updated: 2016-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2012-11-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PVX-410, .4 mg dose
Approximately 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
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
PVX-410, .8 mg dose
Approximately 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
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
PVX-410 plus lenalidomide
Approximately 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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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.
18 Years
95 Years
ALL
No
Sponsors
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OncoPep, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Noopur Raje, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Michael Wang, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Ajay Nooka, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Illinois Cancer Specialists
Niles, Illinois, 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
Countries
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References
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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.
Other Identifiers
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2010-001
Identifier Type: -
Identifier Source: org_study_id
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