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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 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 13 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01380145
The ClinicalTrials.gov registry entry for NCT01380145 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which recMAGE-A3 Protein + AS15 Adjuvant is the first listed.
NCT01380145 reports 0 study locations.
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.
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