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NCT02112045 · ClinicalTrials.gov registry record · Phase 2
A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT02112045: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT02112045 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02112045, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may help multiple myeloma cells move from the patient's bone marrow to the blood where they may be more sensitive to treatment with melphalan. It is not yet known whether adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in treating multiple myeloma
Primary Outcome
Complete response (CR) requires all of the following: * Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine * \<5% plasma cells in the bone marrow * Disappearance of soft tissue plasmacytomas Stringent complete response (sCR) requires all of the following: * CR as defined above * Normal free light chain ratio * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
Interventions
- PROCEDURE Autologous Stem Cell Transplant (ASCT)
- DRUG Granix
- DRUG High dose melphalan (HDR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2015-01-20 |
| Est. Completion | 2019-09-10 |
| Phase | Phase 2 |
Why NCT02112045 stopped before completion
NCT02112045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 3 interventions - of which Autologous Stem Cell Transplant (ASCT) is the first listed.
NCT02112045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02112045 about?
NCT02112045 is a clinical study titled "A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation". This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Giving colony-stimul...
What is the current status of trial NCT02112045?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2015-01-20. Estimated completion is 2019-09-10.
What interventions are being tested in trial NCT02112045?
The interventions under investigation include: Autologous Stem Cell Transplant (ASCT) (PROCEDURE), Granix (DRUG), High dose melphalan (HDR) (DRUG).
Who is sponsoring clinical trial NCT02112045?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02112045's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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