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NCT00948922 · ClinicalTrials.gov registry record · Phase 2

Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma

A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 2
Development phase
124
Enrollment target

NCT00948922: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT00948922 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00948922, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
124 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.

Primary Outcome

PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved

Interventions

  • DRUG Fludarabine
  • DRUG Melphalan
  • DRUG Bortezomib
  • PROCEDURE Autologous Stem Cell Transplant
  • PROCEDURE Allogeneic Stem Cell Transplant

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2009-06-18
Est. Completion 2019-05-14
Phase Phase 2

What the finished NCT00948922 record still lists

NCT00948922 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.

NCT00948922 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00948922 about?

NCT00948922 is a clinical study titled "Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma". The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.

What is the current status of trial NCT00948922?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2009-06-18. Estimated completion is 2019-05-14.

What interventions are being tested in trial NCT00948922?

The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Bortezomib (DRUG), Autologous Stem Cell Transplant (PROCEDURE), Allogeneic Stem Cell Transplant (PROCEDURE).

Who is sponsoring clinical trial NCT00948922?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00948922's enrollment target sits among peer trials

124 564th of 2000 higher than 1,437 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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Source: ClinicalTrials.gov NCT00948922, the US trial registry maintained by the National Library of Medicine. NCT00948922 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.