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NCT00322387 · ClinicalTrials.gov registry record · Phase 2

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

A Phase 2 study of Multiple Myeloma and Lymphoma, Non-Hodgkin, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target
5
Study locations

NCT00322387: Completed Phase 2 study of Multiple Myeloma and Lymphoma, Non-Hodgkin, sponsored by Genzyme, a Sanofi Company.

NCT00322387 is a Phase 2 study of Multiple Myeloma and Lymphoma, Non-Hodgkin that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 40 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00322387, a Phase 2 study of Multiple Myeloma and Lymphoma, Non-Hodgkin, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target
5
Study locations

Study Summary

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Primary Outcome

Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.

Interventions

  • DRUG G-CSF and plerixafor

Study Locations (5)

California

  • City of Hope National Medical Center - Duarte

Indiana

  • Indiana Blood and Marrow Transplantation - Beech Grove

New York

  • University of Rochester Medical Center - Rochester

Oregon

  • Oregon Health and Science University - Portland

Washington

  • Fred Hutchinson Cancer Research Center - Seattle

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2004-04
Est. Completion 2006-07
Phase Phase 2
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00322387 record still lists

NCT00322387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower).

The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which G-CSF and plerixafor is the first listed.

NCT00322387 lists 5 locations in 5 states (California, Indiana, New York).

Frequently Asked Questions

What is clinical trial NCT00322387 about?

NCT00322387 is a clinical study titled "Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients". Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating...

What is the current status of trial NCT00322387?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2004-04. Estimated completion is 2006-07.

What conditions does trial NCT00322387 study?

This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma, Non-Hodgkin.

What interventions are being tested in trial NCT00322387?

The interventions under investigation include: G-CSF and plerixafor (DRUG).

Who is sponsoring clinical trial NCT00322387?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00322387 being conducted?

This trial has 5 study locations across California, Indiana, New York, Oregon, Washington. 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 NCT00322387's enrollment target sits among peer trials

40 289th of 438 higher than 135 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 NCT00322387, the US trial registry maintained by the National Library of Medicine. NCT00322387 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.