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NCT01380145 · ClinicalTrials.gov registry record · Phase 1
MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01380145: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT01380145 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01380145, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the International Myeloma Working Group (IMWG) criteria and who were eligible for high-dose chemotherapy with autologous stem cell transplant (auto-SCT). The primary objective was to determine the safety and tolerability of immunizations when administered prior to stem cell mobilization and multiple times after stem cell reinfusion. Secondary objectives were to assess the humoral and cellular immunogenicity and clinical outcomes of immunization.
Primary Outcome
Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs, with severity graded according to the NCI CTCAE, Version 4.0.
Interventions
- BIOLOGICAL recMAGE-A3 Protein + AS15 Adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01380145 record still lists
NCT01380145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which recMAGE-A3 Protein + AS15 Adjuvant is the first listed.
NCT01380145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01380145 about?
NCT01380145 is a clinical study titled "MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation". This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the International Myeloma...
What is the current status of trial NCT01380145?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01380145?
The interventions under investigation include: recMAGE-A3 Protein + AS15 Adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01380145?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01380145's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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