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NCT01057225 · ClinicalTrials.gov registry record · Phase 1

Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma

A Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
64
Enrollment target

NCT01057225: Completed Phase 1 study, sponsored by Mayo Clinic.

NCT01057225 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01057225, a Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients with newly diagnosed active multiple myeloma.

Primary Outcome

To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs

Interventions

  • DRUG cyclophosphamide
  • DRUG dexamethasone
  • DRUG carfilzomib
  • DRUG thalidomide

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2010-03
Est. Completion 2017-09-05
Phase Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT01057225 record still lists

NCT01057225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which cyclophosphamide is the first listed.

NCT01057225 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01057225 about?

NCT01057225 is a clinical study titled "Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma". RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell...

What is the current status of trial NCT01057225?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2010-03. Estimated completion is 2017-09-05.

What interventions are being tested in trial NCT01057225?

The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), carfilzomib (DRUG), thalidomide (DRUG).

Who is sponsoring clinical trial NCT01057225?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01057225's enrollment target sits among peer trials

64 808th of 2000 higher than 1,181 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 NCT01057225, the US trial registry maintained by the National Library of Medicine. NCT01057225 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.