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NCT00478218 · ClinicalTrials.gov registry record · Phase 2

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

A Phase 2 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT00478218: Completed Phase 2 study, sponsored by Mayo Clinic.

NCT00478218 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00478218, a Phase 2 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study Summary

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. 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. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

Primary Outcome

Response that was confirmed on 2 consecutive evaluations during treatment * Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * Partial Response PR): \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% r

Interventions

  • DRUG cyclophosphamide
  • DRUG dexamethasone
  • DRUG lenalidomide

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2006-07
Est. Completion 2011-04
Phase Phase 2
Mayo Clinic

2,844 total trials

What the finished NCT00478218 record still lists

NCT00478218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 3 interventions - of which cyclophosphamide is the first listed.

NCT00478218 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00478218 about?

NCT00478218 is a clinical study titled "Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma". RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. 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. Givi...

What is the current status of trial NCT00478218?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2006-07. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00478218?

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

Who is sponsoring clinical trial NCT00478218?

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 NCT00478218's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 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 NCT00478218, the US trial registry maintained by the National Library of Medicine. NCT00478218 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.