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NCT01315873 · ClinicalTrials.gov registry record · Phase 2
Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma
A Phase 2 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01315873: Clinical Trial Phase 2 study, sponsored by NYU Langone Health.
NCT01315873 is a Phase 2 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01315873, a Phase 2 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs bendamustine and bortezomib. The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4 of each cycle, with bortezomib being given first, before each dose of bendamustine. Each cycle will be 28 days long, so patients will be treated the first week of each cycle and then have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22 of each cycle. Patients will receive the study drugs until their disease progresses or they are withdrawn from the study. In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to show that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.
Primary Outcome
These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)
Interventions
- DRUG Bendamustine
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
Why NCT01315873 stopped before completion
NCT01315873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Bendamustine is the first listed.
NCT01315873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01315873 about?
NCT01315873 is a clinical study titled "Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma". Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs bendamustine and bortezomib. The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4 of each cycle, with b...
What is the current status of trial NCT01315873?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01315873?
The interventions under investigation include: Bendamustine (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT01315873?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01315873's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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