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NCT02334865 · ClinicalTrials.gov registry record · Phase 1
SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy
A Phase 1 study of Plasma Cell Myeloma and Partial Response of Multiple Myeloma or Plasma Cell Leukemia, sponsored by Roswell Park Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT02334865: Active Phase 1 study of Plasma Cell Myeloma and Partial Response of Multiple Myeloma or Plasma Cell Leukemia, sponsored by Roswell Park Cancer Institute.
NCT02334865 is a Phase 1 study of Plasma Cell Myeloma and Partial Response of Multiple Myeloma or Plasma Cell Leukemia that is active but no longer recruiting, run by Roswell Park Cancer Institute. The registered enrollment target is 18 participants, below the 208-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02334865, a Phase 1 study of Plasma Cell Myeloma and Partial Response of Multiple Myeloma or Plasma Cell Leukemia, is active but no longer recruiting, sponsored by Roswell Park Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant together with sargramostim in treating patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from survivin peptide may help the body build an effective immune response to kill cancer cells that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide maintenance therapy may be a better treatment for multiple myeloma.
Primary Outcome
The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to evaluate toxicity. The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. The frequency of toxicities will also be tabulated for the regimen estimated to be the regimen-limiting toxicity.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Lenalidomide
- BIOLOGICAL Sargramostim
- BIOLOGICAL Incomplete Freund's Adjuvant
- BIOLOGICAL SVN53-67/M57-KLH Peptide Vaccine
Study Locations (2)
New York
- Roswell Park Cancer Institute - Buffalo
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-04-13 |
| Est. Completion | 2026-05-19 |
| Phase | Phase 1 |
What the registry record for NCT02334865 still lists
NCT02334865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 208-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02334865 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02334865 about?
NCT02334865 is a clinical study titled "SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy". This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant together with sargramostim in treating patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from survivin peptide may help the body bu...
What is the current status of trial NCT02334865?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-04-13. Estimated completion is 2026-05-19.
What conditions does trial NCT02334865 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma, Partial Response of Multiple Myeloma or Plasma Cell Leukemia.
What interventions are being tested in trial NCT02334865?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Sargramostim (BIOLOGICAL), Incomplete Freund's Adjuvant (BIOLOGICAL), SVN53-67/M57-KLH Peptide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02334865?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02334865 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02334865's enrollment target sits among peer trials
18 29th of 32 higher than 4 of 32 other Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plasma Cell Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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