CClinicalTrials.gg
Status unknownNCT01042717Updated Sep 27, 2011

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

An interventional study of Plerixafor in Multiple Myeloma and Non-Hodgkins Lymphoma, sponsored by Shi, Patricia, M.D.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-09-27.

Sponsored by Shi, Patricia, M.D. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Multiple Myeloma
  • Non-Hodgkins Lymphoma

Keywords

  • plerixafor
  • autologous transplantation
  • hematopoietic stem cell mobilization
  • multiple myeloma
  • non-Hodgkins lymphoma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 10 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

This is the only study on the registry with Shi, Patricia, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Plerixafor

    Plerixafor 16 hours

    Drug: Plerixafor

Interventions

  • DrugPlerixafor

    Plerixafor administered at 16 hours prior to apheresis

    Also known as: Mozobil

06

What researchers measure

Primary outcomes

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

    Time frame: After collection

Secondary outcomes

  1. Median and average neutrophil and platelet engraftment

    Time frame: After stem cell infusion

  2. Plerixafor-related toxicities

    Time frame: 1 month after stem cell infusion

07

Study locations

1 of 1 sites recruiting
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
    Recruiting
08

References and documents

Publications

  • Liles WC, Rodger E, Broxmeyer HE, Dehner C, Badel K, Calandra G, Christensen J, Wood B, Price TH, Dale DC. Augmented mobilization and collection of CD34+ hematopoietic cells from normal human volunteers stimulated with granulocyte-colony-stimulating factor by single-dose administration of AMD3100, a CXCR4 antagonist. Transfusion. 2005 Mar;45(3):295-300. doi: 10.1111/j.1537-2995.2005.04222.x. PubMed 15752146 ↗
  • DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31. PubMed 19720922 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01042717
Lead sponsor
Shi, Patricia, M.D.
Collaborators
Genzyme, a Sanofi Company
Responsible party
Patricia Shi (Assistant Professor, Hematology-Oncology, Shi, Patricia, M.D.) — Principal investigator
First posted
Jan 6, 2010
Start date
Feb 2010
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Sep 27, 2011

Study contacts

Patricia A Shi, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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