MedTrace Logo

An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells

NCT01753453 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-02-23

No results posted yet for this study

Summary

The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).

Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.

Conditions

Interventions

DRUG

Plerixafor

240mcg/kg, solution, subcutaneous injection

DRUG

Granulocyte-colony stimulating factor (G-CSF)

10 mcg/kg, solution, subcutaneous injection

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Belgium
  • Estonia
  • Lithuania
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753453 on ClinicalTrials.gov