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Prospective Observational Study on Plerixafor After Chemotherapy


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma, Myeloma

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Trial Information

Prospective Observational Study on Plerixafor After Chemotherapy


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Number of patients who were able to collect >= 2 x 10^6 CD34+/kg

Outcome Time Frame:

From day 1 to day 25 after mobilizing chemotherapy

Safety Issue:

No

Principal Investigator

Paolo Corradini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione IRCCS Istituto Nazionale dei Tumori

Authority:

Italy: Ethics Committee

Study ID:

011012

NCT ID:

NCT01700608

Start Date:

September 2008

Completion Date:

April 2012

Related Keywords:

  • Lymphoma
  • Myeloma
  • Lymphoma

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