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Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection

18 Years
75 Years
Open (Enrolling)
Multiple Myeloma, Non-Hodgkins Lymphoma

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Trial Information

Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection

The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis.
This is a logistical problem, since plerixafor should be administered by a health care
provider, given the risk of hypotension with administration. The primary purpose of this
study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing
hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether
the dosing interval can be increased to 16 hours prior to apheresis. Patients will be
admitted to a special clinical research center on the 4th day of G-CSF administration, where
the peripheral blood CD34+ count will be measured every 2 hours after plerixafor
administration at 5 pm until 9 AM the following day, at which time apheresis will commence.
The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and
effective as plerixafor administration at 11 hours prior to apheresis.

Inclusion Criteria:

1. Autologous donors age 18 to 75 years with NHL or MM scheduled to undergo peripheral
blood stem cell collection as part of standard clinical care. Biopsy-confirmed
diagnosis of NHL or MM is to have been done prior to the first mobilization.

2. In first or second CR or PR

3. ECOG performance status of 0 or 1

4. WBC count greater than 2.5 x 10e9/1

5. Absolute PMN count greater than 1.5 x 10e9/1

6. PLT count greater than 100 x 10e9/1

7. Serum creatinine less than or equal to 2.2 mg/dl

8. SGOT, SGPT, and total bilirubin less than 2.5 X upper limit of normal (ULN)

9. Cardiac and pulmonary status sufficient to undergo apheresis and transplantation

10. Negative for HIV

11. 4 weeks since last cycle of chemotherapy. (Rituximab, thalidomide, dexamethasone,
and bortezomib are not considered chemotherapy for the purpose of the study)

12. Patients of childbearing potential agree to use an approved form of contraception

13. Recovered from all acute toxic effects of prior chemotherapy

Exclusion Criteria:

1. Comorbid condition which renders patient, in view of the investigators, at high risk
of treatment complications

2. Failed previous stem cell collections or collection attempts

3. Less than 6 weeks of carmustine prior to the 1st dose of G-CSF

4. Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for

5. Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization

6. Active CNS involvement

7. Active brain metastases or carcinomatous meningitis

8. Bone marrow involvement greater than 20 percent

9. Received radiation therapy to the pelvis

10. Post-transplant chemotherapy and/or radiation therapy below the diaphragm is

11. Received prior radio-immunotherapy with Zevalin or Bexxar

12. Fever (temperature greater than 38 C/100.4 F)

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

14. A residual acute medical condition resulting from prior chemotherapy

15. Active brain metastases or myelomatous meningitis

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

17. Received Revlimid within 3 weeks prior to the first dose of G-CSF

18. Received greater than 6 cycles of Revlimid

19. Positive pregnancy test or lactating

20. Active infection requiring antibiotic treatment

21. Abnormal ECG with clinically significant rhythm disturbance (ventricular
arrhythmias), or other conduction abnormality in the last year that in the opinion of
the investigator warrants exclusion of the subject from the trial.

22. 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.

23. Patients whose apheresis product will be further selected and purified.

24. Prior autologous or allogeneic transplant.

Type of Study:


Study Design:

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

Outcome Measure:

Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection

Outcome Time Frame:

After collection

Safety Issue:


Principal Investigator

Patricia A Shi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:

GCO # 09-0824



Start Date:

February 2010

Completion Date:

December 2011

Related Keywords:

  • Multiple Myeloma
  • Non-Hodgkins Lymphoma
  • plerixafor
  • autologous transplantation
  • hematopoietic stem cell mobilization
  • multiple myeloma
  • non-Hodgkins lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Mount Sinai School of MedicineNew York, New York  10029