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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Shi, Patricia, M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Patricia Shi, Shi, Patricia, M.D.
ClinicalTrials.gov Identifier:
NCT01042717
First received: January 5, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Multiple Myeloma
Non-Hodgkins Lymphoma
Drug: Plerixafor

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection

Resource links provided by NLM:


Further study details as provided by Shi, Patricia, M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Median and average neutrophil and platelet engraftment [ Time Frame: After stem cell infusion ] [ Designated as safety issue: Yes ]
  • Plerixafor-related toxicities [ Time Frame: 1 month after stem cell infusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plerixafor
Plerixafor 16 hours
Drug: Plerixafor
Plerixafor administered at 16 hours prior to apheresis
Other Name: Mozobil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042717

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Patricia A Shi, MD    212-241-9237    patricia.shi@mssm.edu   
Contact: Luis M Isola, MD    212-241-6021    luis.isola@msnyuhealth.org   
Principal Investigator: Patricia A Shi, MD         
Sub-Investigator: Luis M Isola, MD         
Sponsors and Collaborators
Shi, Patricia, M.D.
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Patricia A Shi, MD Mount Sinai School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Patricia Shi, Assistant Professor, Hematology-Oncology, Shi, Patricia, M.D.
ClinicalTrials.gov Identifier: NCT01042717     History of Changes
Other Study ID Numbers: GCO # 09-0824
Study First Received: January 5, 2010
Last Updated: September 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Shi, Patricia, M.D.:
plerixafor
autologous transplantation
hematopoietic stem cell mobilization
multiple myeloma
non-Hodgkins lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014