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Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF


Phase 2
18 Years
70 Years
Not Enrolling
Both
Lymphoma, Non-Hodgkin, Multiple Myeloma

Thank you

Trial Information

Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF


An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were
to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only
change to the standard of care was the addition of plerixafor to a mobilization regimen of
chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as
per local practice guidelines and G-CSF (at customary doses) and apheresis was performed.
After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second
apheresis the next day or in the morning of the second day, 6 hours before the second
apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor
dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were
compared.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Inclusion Criteria


Inclusion Criteria (Abbreviated List):

- MM in first partial response/complete response, first relapse, or second
partial/complete response

- NHL in first or second partial or complete remission

- NHL patients who do not have bone marrow involvement and < 10% for follicular
involvement

- MM patients who have stable disease with < 40% bone marrow involvement

- No more than three prior regimens of chemotherapy (thalidomide and Decadron are not
considered chemotherapy)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- White blood cell count (WBC) >3.0 x 10^9/L

- Absolute neutrophil count >1.5 x 10^9/L

- Platelet count >100 x 10^9/L

Exclusion Criteria (Abbreviated List):

- Brain metastases or carcinomatous meningitis

- Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]

- Cardiovascular disease that includes proven or predisposition to ventricular
arrhythmias

- Acute Infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant

Outcome Description:

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.

Outcome Time Frame:

13 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD3100-2104

NCT ID:

NCT00322387

Start Date:

April 2004

Completion Date:

July 2006

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • Stem cell mobilization
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Rochester Medical CenterRochester, New York  14642
City of Hope National Medical CenterLos Angeles, California  91010
Indiana Blood and Marrow TransplantationIndianapolis, Indiana  46202
Oregon Health and Science UniversityPortland, Oregon  97201