Prospective Observational Study on Plerixafor After Chemotherapy

Completed

• Conditions: Lymphoma; Myeloma
• Interventions: Drug: plerixafor

• Registration Number: NCT01700608
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect \>=2 x 10\^6 CD34+/kg.

Detailed Description

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect \>=2 x 10\^6 CD34+/kg. Secondary endpoint was the assessment of the rate of patients collecting \> 4 x 10\^6 CD34+/kg and the median number of apheresis to reach the target.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-10
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-02
• Last Update Submitted: 2012-10-02
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF

Exclusion Criteria

• patients treated only with G-CSF and plerixafor without chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
plerixafor treated patients	plerixafor	lymphoma and myeloma patients

Primary Outcome Measures

Name	Time	Method
Number of patients who were able to collect >= 2 x 10^6 CD34+/kg	From day 1 to day 25 after mobilizing chemotherapy

Secondary Outcome Measures

Name	Time	Method
Number of patients who were able to collect > 4 x 10^6 CD34+/kg.	From day 1 to day 25 after mobilizing chemotherapy

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy