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NCT01729338 · ClinicalTrials.gov registry record · Phase 2
Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01729338 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 17 participants.
The verdict
NCT01729338, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary purpose of this study is to estimate the overall response rate (ORR), defined as partial response (PR) or better at any time during induction therapy. The success of the therapy will be determined by ORR with strong consideration given to the secondary endpoints of tolerability, duration of response, and quality of life (QOL). All patients will be treated with the same experimental regimen. Several novel features are being explored: the substitution of cyclophosphamide for melphalan; once weekly AND subcutaneous bortezomib instead of standard twice weekly, intravenous dosing; and alternating bortezomib and lenalidomide in maintenance. The investigators hypothesize that this regimen will prove to be tolerable and effective in inducing and maintaining remission in a patient population that is historically very difficult to treat, namely Multiple Myeloma (MM) patients who are too elderly or suffer comorbidities, such as renal insufficiency, that otherwise complicate aggressive therapies like autologous stem-cell transplantation (ASCT). In short, the investigators view this as the "Multiple Myeloma trial for non-trial candidates."
Interventions
- DRUG Cyclophosphamide
- DRUG Revlimid
- DRUG Velcade
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-12-19 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01729338
The ClinicalTrials.gov registry entry for NCT01729338 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01729338 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01729338 about?
NCT01729338 is a clinical study titled "Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma". The primary purpose of this study is to estimate the overall response rate (ORR), defined as partial response (PR) or better at any time during induction therapy. The success of the therapy will be determined by ORR with strong consideration given to the secondary endpoints of tolerability, duration...
What is the current status of trial NCT01729338?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2012-12-19. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT01729338?
The interventions under investigation include: Cyclophosphamide (DRUG), Revlimid (DRUG), Velcade (DRUG).
Who is sponsoring clinical trial NCT01729338?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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