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NCT01182233 · ClinicalTrials.gov registry record · Phase 1
Total Skeletal Irradiation in Multiple Myeloma Before Second Autologous Hematopoietic Stem Cell Transplantation
A Phase 1 study, sponsored by University of Rochester.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01182233 is a Phase 1 study that was terminated before completion, run by University of Rochester. The registered enrollment target is 4 participants.
The verdict
NCT01182233, a Phase 1 study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to improve the efficacy of the HDC regimen by adding a novel, "targeted" means administering a variation of total body irradiation (TBI) radiation i.e., total skeletal irradiation (TSI) administered by helical tomotherapy (HT) before, and in addition to the current standard of HDC, at a dose of 200 mg/m2 (HDMel200). The underlying postulate of this endeavor is that TSI-HT will provide additional cytoreduction to HDMel alone, without producing additional (serious) toxicity. We will utilize a classical Phase I study design (i.e., dose escalation) in myeloma patients undergoing AHSCT2 to define a maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Finally, although comparisons to other therapies are not typical (and/or feasible) for a Phase I study, we will compare, whenever possible, both the toxicity and the antimyeloma activity of the AHSCT2 to AHSCT1. This protocol will standardize, as much as possible the use of AHSCT2 both as a "tandem" and "salvage" procedure. Since sufficient AHSC (CD34+ cells) are routinely collected in adequate numbers for multiple AHSCTs, but recently used infrequently, it is important to work towards defining the optimal utilization of this resource.
Interventions
- RADIATION Total Skeletal Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01182233
The ClinicalTrials.gov registry entry for NCT01182233 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Total Skeletal Irradiation is the first listed.
NCT01182233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01182233 about?
NCT01182233 is a clinical study titled "Total Skeletal Irradiation in Multiple Myeloma Before Second Autologous Hematopoietic Stem Cell Transplantation". The purpose of this study is to improve the efficacy of the HDC regimen by adding a novel, "targeted" means administering a variation of total body irradiation (TBI) radiation i.e., total skeletal irradiation (TSI) administered by helical tomotherapy (HT) before, and in addition to the current stand...
What is the current status of trial NCT01182233?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2010-06. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01182233?
The interventions under investigation include: Total Skeletal Irradiation (RADIATION).
Who is sponsoring clinical trial NCT01182233?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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