Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shi, Patricia, M.D.
• Collaborator: Genzyme, a Sanofi Company
• Treatments: JM 3100; Plerixafor

Criteria

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 mobilization

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 anticipated

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.