Collection of Transplant Stem Cells for Plasma Cell Myeloma

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT01547806
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arm: 1
• Actual Duration (Months): 70.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Background:

• One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem cell transplant. Researchers want to collect stem cells from the blood for later transplant.

Objectives:

• To collect stem cells for transplant as part of treatment for plasma cell myeloma.

Eligibility:

• Individuals at least 18 years of age who will have chemotherapy and stem cell transplant for plasma cell myeloma.

Design:

• Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.

• Participants will have filgrastim injections for 5 days before collection. This will move stem cells from the bone marrow to the blood.

• Participants will have apheresis to collect the stem cells.

• Participants who need additional apheresis procedures to collect stem cells will have filgrastim and a dose of plerixafor to improve the collection yield.

Condition or Disease	Intervention/Treatment	Phase
Plasma Cell Myeloma; Multiple Myeloma	Drug: Filgrastim; Drug: Plerixafor; Procedure: Apheresis	Phase 2

Detailed Description

Background:

High-dose chemotherapy followed by autologous hematopoietic cell transplant (AHCT) remains a critical part of the Plasma Cell Myeloma (PCM) treatment in subjects eligible for the procedure. The timing of the procedure however, has become more controversial recently. This protocol will allow collection of Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) in potential candidates for various PCM protocols at the Clinical Center.

The mobilizing agent plerixafor (Mozobil, Genzyme) has been recently approved by the Food and Drug Administration (FDA) for mobilization in PCM. However, the best and most cost effective strategy for its use remains to be defined.

Objectives:

Evaluate the overall validity of an HPC mobilization strategy (with granulocyte-colony stimulating factor (G-CSF) alone or in combination with plerixafor) using a formula calculating the likelihood of collecting greater than or equal to 5 time 10^6 cluster of differentiation 34 (CD34) plus cells/kg in a single mobilization cycle.

Collect mobilized Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) prior to AHCT for PCM

Eligibility:

Subjects with a possible indication for AHCT for the treatment of newly diagnosed PCM.

Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM.

Design:

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Mobilization will be provided by a 5-daily administration of filgrastim according to standard procedure.

The need for an additional mobilizing agent (plerixafor) to be given on day 4 of mobilization will be evaluated in real time in each patient, based on the peripheral blood CD34 count on the morning of day 4 of filgrastim administration.

Study accrual over a 3-year period: 70 subjects

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)
• Actual Study Start Date: Feb 22, 2012
• Actual Primary Completion Date: Jun 17, 2014
• Actual Study Completion Date: Jan 11, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Hematopoietic Progenitor Cells (HPC) Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Drug: Filgrastim; Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days; Other Names: Neupogen ; Drug: Plerixafor; Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight; Other Names: Mozobil ; Procedure: Apheresis; The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis [Day 1 of apheresis]

   Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE^6/kg following apheresis.

2. Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight [Through Day 2 of collection]

   Progenitor cells by apheresis was determined by flow cytometry.

3. Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW)) [Through Day 2 of collection]

   Progenitor cells by apheresis was determined by flow cytometry.

4. Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW) [Through Day 2 of collection]

   Progenitor cells by apheresis was determined by flow cytometry.

5. Range of Cluster of Differentiation 34 (CD34) Cells Collected [Through Day 2 of collection]

   Progenitor cells by apheresis was determined by flow cytometry.

6. 25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected [Through Day 2 of collection]

   Progenitor cells by apheresis was determined by flow cytometry.

7. Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM) [Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of]

   The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.

Secondary Outcome Measures

1. Number of Participants With Serious and Non-Serious Adverse Events [27 months and 27 days]

   Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

2. Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor) [One week of mobilization therapy]

   Percentage of patients that required Plerixafor injection in addition to G-CSF mobilization or none at all

3. Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg [Through Day 2 of collection]

   Here is the percentage of patients that achieved or did not achieve 5 x 10^6 CD34 cells/kg in a single apheresis.

4. Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection) [Day one of collection]

   Percentage of patents achieving collecting the minimum but not optimal CD34 cell number.

5. Degree of Tumor Cell Contamination in the Final Product [Day 1 of apheresis]

   Flow cytometry to detect tumor contamination.

6. Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product [Day 1 of apheresis]

   Flow cytometry to detect tumor contamination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• INCLUSION CRITERIA:

Multiple Myeloma Criteria:

Subjects with an indication for autologous hematopoietic cell transplant (AHCT) for the treatment of PCM as determined by the principal investigator (PI) or lead associate investigator (LAI).

• Subjects following induction treatment for plasma cell myeloma (PCM)

• Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM.

Other Eligibility Criteria:

Age greater than or equal to 18 years and less than or equal to 75 years. In subjects between 65 and 75 years of age, physiologic age and co-morbidity will be thoroughly evaluated before enrolling.

Karnofsky performance status of 70% or greater (Eastern Cooperative Oncology Group ((ECOG) 0 or 1)

Ejection fraction (EF) by multigated acquisition scan (MUGA) or 2-D echocardiogram within institution normal limits. In case of low ejection fraction (EF), the subject may remain eligible after a stress echocardiogram is performed if the EF is more than 35% and if the increase in EF with stress is estimated at 10% or more.

Hemoglobin (Hgb) greater than or equal to 8 g/dl (transfusion acceptable)

No history of abnormal bleeding tendency.

Patients must be able to give informed consent

EXCLUSION CRITERIA:

Prior allogeneic stem cell transplantation

Hypertension not adequately controlled by 3 or less medications.

Clinically significant cardiac pathology: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to New York Heart Association (NYHA), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Specifically, any history of cardio-vascular pathology or symptoms, not clearly fitting this exclusion criterion will prompt an evaluation by a Clinical Center Cardiologist and eligibility will be considered on a case-by-case basis. Should the cardiologist deem the patients findings on work-up to be not clinically significant pathology, the patient will have met this exclusion criterion.

Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.

Active hepatitis B or C infection

Human immunodeficiency virus (HIV) seropositive, with positive confirmatory nucleic acid test

Patients known or found to be pregnant.

Patients of childbearing age who are unwilling to practice contraception.

Patients may be excluded at the discretion of the principal investigator (PI)/lead associate investigator (LAI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jennifer Kanakry, M.D., National Cancer Institute (NCI)

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 23, 2017

More Information

Additional Information:

• NIH Clinical Center Detailed Web Page

Publications

• Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am J Hematol. 1990 Feb;33(2):86-9.
• Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
• Ogunniyi A, Rodriguez M, Devlin S, Adel N, Landau H, Chung DJ, Lendvai N, Lesokhin A, Koehne G, Mailankody S, Korde N, Reich L, Landgren O, Giralt S, Hassoun H. Upfront use of plerixafor and granulocyte-colony stimulating factor (GCSF) for stem cell mobilization in patients with multiple myeloma: efficacy and analysis of risk factors associated with poor stem cell collection efficiency. Leuk Lymphoma. 2017 May;58(5):1123-1129. doi: 10.1080/10428194.2016.1239261. Epub 2016 Oct 13.
• Tosi P, Zamagni E, Cellini C, Plasmati R, Cangini D, Tacchetti P, Perrone G, Pastorelli F, Tura S, Baccarani M, Cavo M. Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma. Eur J Haematol. 2005 Mar;74(3):212-6.

• Responsible Party: Jennifer Kanakry, M.D., Principal Investigator, National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT01547806
• Other Study ID Numbers: 120074; 12-C-0074
• First Posted: Mar 8, 2012
• Last Update Posted: Mar 7, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jennifer Kanakry, M.D., Principal Investigator, National Cancer Institute (NCI): Autologous Hematopoietic Cell Transplantation; Plasma Cell Myeloma; Mobilization; Apheresis; Plerixafor
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plerixafor

Study Results

Participant Flow

Pre-assignment Detail	Our study was a relatively small pilot study, with the primary emphasis being on expanding standard stem cell therapy options for patients with multiple myeloma. The plerixafor plus G-CSF combination is used relatively ubiquitously, and several larger studies relating to plerixafor have been performed at large centers that treat multiple myeloma.

Arm/Group Title	Hematopoietic Progenitor Cells (HPC)
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg.
Period Title: Overall Study
STARTED	49
COMPLETED	49
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Hematopoietic Progenitor Cells (HPC)
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106^ CD34+ cells/kg.
Overall Participants	49
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 81.6%
>=65 years	9 18.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.99 (8.45)
Sex: Female, Male (Count of Participants)
Female	23 46.9%
Male	26 53.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	48 98%
Unknown or Not Reported	1 2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2%
Asian	1 2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 14.3%
White	40 81.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	49 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis
Description	Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE^6/kg following apheresis.
Time Frame	Day 1 of apheresis

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells (HPC)
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg.
Measure Participants	49
Number [percentage of patients]	98

2. Primary Outcome

Title	Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight
Description	Progenitor cells by apheresis was determined by flow cytometry.
Time Frame	Through Day 2 of collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
Number [percentage of patients]	2

3. Primary Outcome

Title	Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))
Description	Progenitor cells by apheresis was determined by flow cytometry.
Time Frame	Through Day 2 of collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
Mean (Standard Deviation) [Number of CD34 cells per kg/BW (x 10EE6)]	6.4 (2.8)

4. Primary Outcome

Title	Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)
Description	Progenitor cells by apheresis was determined by flow cytometry.
Time Frame	Through Day 2 of collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
Median (Standard Deviation) [Number of CD34 cells per kg/BW (x 10EE6)]	6.3 (2.8)

5. Primary Outcome

Title	Range of Cluster of Differentiation 34 (CD34) Cells Collected
Description	Progenitor cells by apheresis was determined by flow cytometry.
Time Frame	Through Day 2 of collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
Median (Full Range) [Number of CD34 cells per kg/BW (x 10EE6)]	6.3

6. Primary Outcome

Title	25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected
Description	Progenitor cells by apheresis was determined by flow cytometry.
Time Frame	Through Day 2 of collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
25th percentile	4.0
75th percentile	8.0

7. Primary Outcome

Title	Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)
Description	The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.
Time Frame	Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells (HPC)
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg.
Measure Participants	49
Number [products]	49

8. Secondary Outcome

Title	Number of Participants With Serious and Non-Serious Adverse Events
Description	Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame	27 months and 27 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells (HPC)
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg.
Measure Participants	49
Count of Participants [Participants]	16 32.7%

9. Secondary Outcome

Title	Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)
Description	Percentage of patients that required Plerixafor injection in addition to G-CSF mobilization or none at all
Time Frame	One week of mobilization therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
Plerixafor + G-CSF	47
Only G-CSF (no plerixafor)	53

10. Secondary Outcome

Title	Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg
Description	Here is the percentage of patients that achieved or did not achieve 5 x 10^6 CD34 cells/kg in a single apheresis.
Time Frame	Through Day 2 of collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
Achieved 5 x 10EE CD34 cells/kg	65
Did not achieve 5 x 10EE CD34 cells/kg	35

11. Secondary Outcome

Title	Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)
Description	Percentage of patents achieving collecting the minimum but not optimal CD34 cell number.
Time Frame	Day one of collection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
Measure Participants	49
Number [percentage of patients]	31

12. Secondary Outcome

Title	Degree of Tumor Cell Contamination in the Final Product
Description	Flow cytometry to detect tumor contamination.
Time Frame	Day 1 of apheresis

Outcome Measure Data

Analysis Population Description

No data from any participant was sufficiently collected to assess tumor cell contamination.

Arm/Group Title	Hematopoietic Progenitor Cells (HPC)
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg.
Measure Participants	0

13. Secondary Outcome

Title	Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product
Description	Flow cytometry to detect tumor contamination.
Time Frame	Day 1 of apheresis

Outcome Measure Data

Analysis Population Description

Because no data from any participant was sufficiently collected to assess tumor cell contamination, we were not able to determine the effect of plerixafor on this parameter.

Arm/Group Title	Hematopoietic Progenitor Cells (HPC)
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg.
Measure Participants	0

Adverse Events

Time Frame	27 months and 27 days
Arm/Group Title	Hematopoietic Progenitor Cells
Arm/Group Description	Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols. Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
All Cause Mortality
	Hematopoietic Progenitor Cells
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Serious Adverse Events
	Hematopoietic Progenitor Cells
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	Hematopoietic Progenitor Cells
	Affected / at Risk (%)	# Events
Total	16/49 (32.7%)
Investigations
Lymphocyte count decreased	4/49 (8.2%)	4
Platelet count decreased	5/49 (10.2%)	5
Metabolism and nutrition disorders
Hypoalbuminemia	1/49 (2%)	1
Hypokalemia	2/49 (4.1%)	2
Hypomagnesemia	1/49 (2%)	1
Hypophosphatemia	1/49 (2%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/49 (2%)	1
Myalgia	1/49 (2%)	1
Nervous system disorders
Headache	1/49 (2%)	1
Vascular disorders
Hypertension	1/49 (2%)	1
Phlebitis	1/49 (2%)	1

Limitations/Caveats

The sample size in outcome measure number 6 was inadequate. Results were not conclusive and the information is determined to be too preliminary to present. No conclusion should be drawn from the reported data for this outcome.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.