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NCT01242267 · ClinicalTrials.gov registry record · Phase 1

Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT

A Phase 1 study, sponsored by Hackensack Meridian Health.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT01242267: Completed Phase 1 study, sponsored by Hackensack Meridian Health.

NCT01242267 is a Phase 1 study that has completed, run by Hackensack Meridian Health. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01242267, a Phase 1 study, has completed, sponsored by Hackensack Meridian Health.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

The primary objective of this study is to: • Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of patients who failed a prior treatment with dose-intense melphalan The secondary objectives of this study are to: * Determine the toxicities resulting from administration of combinations of thalidomide, bortezomib and melphalan * Determine the complete response (CR) and very good partial response (VgPR) rate in patients undergoing ASCT using thalidomide, bortezomib and melphalan * Evaluate the treatment-free interval after treatment with the combination of thalidomide, bortezomib and melphalan

Primary Outcome

Maximum tolerated dose of thalidomide used in conjunction with dose-intense melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of patients who failed a prior treatment with dose-intense melphalan

Interventions

  • DRUG Thalidomide+Melphalan +Bortezomib+stem cell transplant

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2010-05-11
Est. Completion 2016-01-20
Phase Phase 1
Hackensack Meridian Health

90 total trials

What the finished NCT01242267 record still lists

NCT01242267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which Thalidomide+Melphalan +Bortezomib+stem cell transplant is the first listed.

NCT01242267 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01242267 about?

NCT01242267 is a clinical study titled "Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT". The primary objective of this study is to: • Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of patients who failed a prior treatment with dose-intense melphalan The second...

What is the current status of trial NCT01242267?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2010-05-11. Estimated completion is 2016-01-20.

What interventions are being tested in trial NCT01242267?

The interventions under investigation include: Thalidomide+Melphalan +Bortezomib+stem cell transplant (DRUG).

Who is sponsoring clinical trial NCT01242267?

This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01242267's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01242267, the US trial registry maintained by the National Library of Medicine. NCT01242267 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.