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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: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT01729338 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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."
Primary Outcome
Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria: IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but n
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 |
Why NCT01729338 stopped before completion
NCT01729338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01729338 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01729338's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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