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

Sponsor

Shi, Patricia, M.D. (Other)

Overall Status

Unknown status

CT.gov ID

NCT01042717

Collaborator

Genzyme, a Sanofi Company (Industry)

Enrollment

Location

Arm

21.9

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Non-Hodgkins Lymphoma	Drug: Plerixafor	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plerixafor Plerixafor 16 hours	Drug: Plerixafor Plerixafor administered at 16 hours prior to apheresis Other Names: Mozobil

Arm

Intervention/Treatment

Experimental: Plerixafor

Plerixafor 16 hours

Drug: Plerixafor

Plerixafor administered at 16 hours prior to apheresis

Other Names:

Mozobil

Outcome Measures

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 [After collection]

Secondary Outcome Measures

Median and average neutrophil and platelet engraftment [After stem cell infusion]
Plerixafor-related toxicities [1 month after stem cell infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
In first or second CR or PR
ECOG performance status of 0 or 1
WBC count greater than 2.5 x 10e9/1
Absolute PMN count greater than 1.5 x 10e9/1
PLT count greater than 100 x 10e9/1
Serum creatinine less than or equal to 2.2 mg/dl
SGOT, SGPT, and total bilirubin less than 2.5 X upper limit of normal (ULN)
Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
Negative for HIV
4 weeks since last cycle of chemotherapy. (Rituximab, thalidomide, dexamethasone, and bortezomib are not considered chemotherapy for the purpose of the study)
Patients of childbearing potential agree to use an approved form of contraception
Recovered from all acute toxic effects of prior chemotherapy

Exclusion Criteria:

Comorbid condition which renders patient, in view of the investigators, at high risk of treatment complications
Failed previous stem cell collections or collection attempts
Less than 6 weeks of carmustine prior to the 1st dose of G-CSF
Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for mobilization
Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization
Active CNS involvement
Active brain metastases or carcinomatous meningitis
Bone marrow involvement greater than 20 percent
Received radiation therapy to the pelvis
Post-transplant chemotherapy and/or radiation therapy below the diaphragm is anticipated
Received prior radio-immunotherapy with Zevalin or Bexxar
Fever (temperature greater than 38 C/100.4 F)
Received bone-seeking radionuclides (e.g., holmium)
A residual acute medical condition resulting from prior chemotherapy
Active brain metastases or myelomatous meningitis
Received thalidomide, dexamethasone and/or Velcade within 7 days prior to the first dose of G-CSF
Received Revlimid within 3 weeks prior to the first dose of G-CSF
Received greater than 6 cycles of Revlimid
Positive pregnancy test or lactating
Active infection requiring antibiotic treatment
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.
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.
Patients whose apheresis product will be further selected and purified.
Prior autologous or allogeneic transplant.