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Effect of AMD3100 (240µg/kg) on the Apheresis Yield of CD34+ Cells When Given To Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Predicted to be Unable to Mobilize ≥2 x 10^6 CD34+ Cells in Three Apheresis Days When Given G-CSF Alone


Phase 2
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma, Lymphoma, Non-Hodgkin's

Thank you

Trial Information

Effect of AMD3100 (240µg/kg) on the Apheresis Yield of CD34+ Cells When Given To Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Predicted to be Unable to Mobilize ≥2 x 10^6 CD34+ Cells in Three Apheresis Days When Given G-CSF Alone


A Phase 2, single-center, open-label study to assess the safety and hematological activity
of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who
were predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. The
only change to the standard of care was the addition of plerixafor to a G-CSF mobilization
regimen on the day prior to apheresis.

Following screening procedures, eligible patients undergo mobilization with G-CSF (10 µg/kg
every day) for 5 days and their peripheral blood (PB) CD34+ cell count was measured on the
fifth day.

On Day 5, if the patient's peripheral CD34+ cell count was <5 cells/µl or ≥20 cells/µl, the
patient did not enter this study and was treated as per the policy of the study site.

On Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the
patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that
evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor
followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of
apheresis or until ≥5*10^6 cells/kg are collected.

On Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive),
then he/she underwent apheresis that day. If this apheresis yield was <1.3*10^6 CD34+
cells/kg, then the patient was predicted to be unlikely to collect ≥2*10^6 CD34+ cells/kg in
≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the
apheresis yield on Day 5 was ≥1.3*10^6 CD34+ cells/kg, then the patient did not enter the
study.

The next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis
approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis
yield was at least double the apheresis yield on Day 5, then the patient received another
10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after
receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and
apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg
were collected.

All patients, after the completion of apheresis procedures (or after ≥5*10^6 cells/kg were
collected), received high-dose chemotherapy in preparation for transplantation. Patients
were transplanted with cells collected after receiving plerixafor with G-CSF. However, if
there were insufficient cells, cells collected after receiving plerixafor with G-CSF could
be pooled with cells collected after receiving G-CSF alone.

Hematological activity of plerixafor was evaluated by assessing the number of CD34+ cells
harvested during apheresis.

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):

- Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)

- Eligible for autologous transplantation

- <=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the
purpose of this study)

- >4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for
the purpose of this study)

- Total dose of melphalan ≦200 mg

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

- White blood cell (WBC) count >3.0*10^9/L prior to first dose of G-CSF

- Absolute polymorphonuclear leukocyte (PMN) count >1.5*10^9/L prior to first dose of
G-CSF

- Platelet (PLT) count >100*10^9/L prior to first dose of granulocyte
colony-stimulating factor (G-CSF)

- Serum creatinine ≥2.2 mg/dL

- SGOT, SGPT and total bilirubin <2 times upper limit of normal (ULN)

- Negative for HIV

- CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with
G-CSF alone

Exclusion Criteria (Abbreviated List):

- A co-morbid condition which, in the view of the investigator, renders the patient at
high risk from treatment complications

- Failed previous stem cell collection or collection attempts

- A residual acute medical condition resulting from prior chemotherapy

- Active brain metastases or carcinomatous meningitis

- Active infection requiring antibiotic treatment

- Received prior radio-immunotherapy with Zevalin or Bexxar

- Received bone-seeking radionuclides (e.g., holmium)

- Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first
dose of G-CSF

- History of ventricular arrhythmias, including electrocardiogram (ECG)-documented
premature ventricular contractions (PVCs), during the last 3 years

- Patients who previously received experimental therapy within 4 weeks of enrolling in
this protocol or who are currently enrolled in another experimental protocol during
the mobilization phase

- Had an apheresis yield >1.3*10^6 CD34+ cells/kg on Day 5 (Applicable only to patients
who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of
8-19 cells/µl inclusive).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days

Outcome Description:

The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.

Outcome Time Frame:

approximately days 6-9

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD3100-2109

NCT ID:

NCT00395967

Start Date:

April 2005

Completion Date:

August 2006

Related Keywords:

  • Multiple Myeloma
  • Lymphoma, Non-Hodgkin's
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • stem cell mobilization
  • autologous transplantation
  • AMD3100
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Duke University Medical Center - Adult BMT Program Durham, North Carolina  27705