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NCT00507442 · ClinicalTrials.gov registry record · Phase 1

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients

A Phase 1 study of Multiple Myeloma, sponsored by Millennium Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
158
Enrollment target
2
Study locations

NCT00507442: Completed Phase 1 study of Multiple Myeloma, sponsored by Millennium Pharmaceuticals.

NCT00507442 is a Phase 1 study of Multiple Myeloma that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 158 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00507442, a Phase 1 study of Multiple Myeloma, has completed, sponsored by Millennium Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
158 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.

Primary Outcome

Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h

Conditions Studied

Interventions

  • DRUG cyclophosphamide
  • DRUG dexamethasone
  • DRUG Revlimid (lenalidomide)
  • DRUG VELCADE (bortezomib)

Study Locations (2)

Colorado

  • Rocky Mountain Cancer Center - Denver

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2007-08
Est. Completion 2010-11
Phase Phase 1
Millennium Pharmaceuticals

135 total trials

What the finished NCT00507442 record still lists

NCT00507442 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (71% lower).

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which cyclophosphamide is the first listed.

NCT00507442 reports a single indexed study location in Colorado, Minnesota.

Frequently Asked Questions

What is clinical trial NCT00507442 about?

NCT00507442 is a clinical study titled "Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients". The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will ev...

What is the current status of trial NCT00507442?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2007-08. Estimated completion is 2010-11.

What conditions does trial NCT00507442 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT00507442?

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

Who is sponsoring clinical trial NCT00507442?

This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00507442 being conducted?

This trial has 2 study locations across Colorado, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00507442's enrollment target sits among peer trials

158 128th of 438 higher than 311 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma 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 NCT00507442, the US trial registry maintained by the National Library of Medicine. NCT00507442 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.