Autologous Transplantation
Conditions
Keywords
Autologous Transplantation
Brief summary
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop. The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis. We will also assess the safety of giving plerixafor 17 hours before apheresis.
Interventions
DRUGPlerixafor
Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Sponsors
Genzyme, a Sanofi Company
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years 2. MM patients in first or second complete or partial remission 3. ECOG performance status of 0 or 1 4. Up to 3 prior treatment regimens 5. Meet all eligibility requirements for autologous transplant 6. Adequate marrow function defined as WBC \>3,000; ANC \>1,500/mm3 ; Platelets \>75,000/mm3 7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault 8. Adequate liver function defined as AST/ALT/Bilirubin \< 2 times upper limit of normal 9. Able to provide informed consent 10. Women not pregnant and agree to use contraception
Exclusion criteria
1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease) 2. Brain metastases or carcinomatous meningitis 3. Previous treatment with high dose chemotherapy and autologous transplant. 4. Previous attempt to collect B-HPCs following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors. 5. Acute infection or unexplained fever \>38°C 6. Weight \> 175% of ideal body weight as defined by the Devine equation. 7. Experimental therapy within 4 weeks 8. Cytokine administration in the previous 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500. | Within the first 5 days following plerixafor initiation |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs | Within the first 5 days following plerixafor initiation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plerixafor 17 Hours Prior to Apheresis Dosing of plerixafor will occur at 3PM (1500 hours).
Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missing data or Not receiveing studydrug | 3 |
Baseline characteristics
| Characteristic | Plerixafor 17 Hours Prior to Apheresis |
|---|---|
| Age, Customized | 59 Years |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 31 |
| serious Total, serious adverse events | 2 / 31 |
Outcome results
Primary
Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.
Time frame: Within the first 5 days following plerixafor initiation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plerixafor 17 Hours Prior to Apheresis | Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500. | 31 Participants |
Secondary
Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs
Time frame: Within the first 5 days following plerixafor initiation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plerixafor 17 Hours Prior to Apheresis | Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs | 22 Participants |