Status:
COMPLETED
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Multiple Myeloma
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and ca...
Detailed Description
This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation are eligible t...
Eligibility Criteria
Inclusion
- Age 18 to 75 years.
- Diagnosis of NHL, HD or MM
- Eligible for autologous transplantation
- CD34+ cell count \< 7 cells/ul after 5 days of mobilization with G-CSF or CD34+ cell count between 7 and 19 (inclusive) on day 5 of mobilization with G-CSF and \< 1.3 x 106 CD34+ cells collected by apheresis on day 5 of G-CSF therapy.
- \< or equal to 5 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- ≥ 3 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization (Rituxan and Lenalidomide are not considered chemotherapy for the purpose of this study)
- Total dose of melphalan \< or equal to 200 mg
- ECOG performance status of 0 or 1
- Recovered from all acute toxic effects of prior chemotherapy
- Absolute PMN count \> 1.0 X 10(9)/l prior to first dose of G-CSF
- PLT count \> 75 X 10(9)/l prior to first dose of G-CSF
- Serum creatinine \< or equal to 2.5 mg/dl
- SGOT, SGPT and total bilirubin \< 2 X upper limit of normal (ULN) prior to the first dose of G-CSF
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as determined by standard institutional practice
- Signed informed consent
- Patients of childbearing potential agree to use an approved form of contraception
Exclusion
- 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 (excluding controlled catheter-related bacteremia)
- Received prior radio-immunotherapy with Zevalin or Bexxar
- Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
- Positive pregnancy test in female patients
- Lactating females
- Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00901225
Start Date
May 1 2009
End Date
May 1 2013
Last Update
May 7 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27705