Lymphoma, Non-Hodgkin, Multiple Myeloma
Conditions
Keywords
Non-Hodgkin's Lymphoma, Multiple Myeloma, stem cell mobilization, AMD3100, autologous transplantation
Brief summary
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.
Detailed description
Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of plerixafor to a granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to apheresis. Participants will undergo mobilization with G-CSF (10 mcg/kg each day) and will receive plerixafor (240 mcg/kg) in the evening prior to apheresis. Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem cells (≥ 5\*10\^6 CD34+ cells/kg for either single or tandem transplant). After apheresis, all participants will be treated with high-dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The increase in CD34+ cells in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and the number of CD34+ cells in the apheresis product will be measured. Success of the transplantation(s) will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMN). A subpopulation will have pharmacokinetic and pharmacodynamic analysis done. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Interventions
Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation * No more than 3 prior regimens of chemotherapy * More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * White blood cell (WBC) count \>3.0\*10\^9/L * Absolute polymorphonuclear cells (PMN) count \>1.5\*10\^9/L * Platelet (PLT) count \>100\*10\^9/L * Serum creatinine \<=2.2 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 x upper limit of normal (ULN) * Left ventricle ejection fraction \>45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan * Forced expiratory volume of the lung in the first second (FEV1) \>60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) \>45% of predicted * Negative for human immunodeficiency virus (HIV) type 1 * Women of child bearing potential agreed to use an approved form of contraception.
Exclusion criteria
* • Patients who have failed previous collections * Brain metastases or carcinomatous meningitis * History of ventricular arrhythmias * A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications * A residual acute medical condition resulting from prior chemotherapy * Acute infection * Fever (temp \>38°C/100.4°F) * Patients whose actual body weight exceeds 150% of their ideal body weight * History of paresthesias (at least Grade 2) * Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period * Positive pregnancy test in female patients * Lactating females * Patients of child-bearing potential unwilling to implement adequate birth control. * Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | Day 1 to approximately Day 38 (before start of chemotherapy) | Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related'). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | 2 months | Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment. |
| Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment | Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis. | In a subpopulation of NHL participants, the mobilization of NHL cells was to be evaluated. None of the samples were analyzed due to sample degradation. |
| Single-dose Maximum Observed Concentration of Plerixafor (Cmax) | Day 5 - 0 to 10 hours post-first plerixafor dose. | Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data. |
| Single-dose Time to Maximum Concentration of Plerixafor (Tmax) | Day 5 - 0 to 10 hours post-first plerixafor dose | Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data. |
| Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells | Time 0 to 11 hours after the first dose of plerixafor | To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor. |
| Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10) | Day 5 - 0 to 10 hours post-first plerixafor dose. | Evaluation of AUC0-10 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. AUC0-10 was determined from non-compartmental analysis. |
| Single-dose Apparent Clearance of Plerixafor (CL/F) | Day 5 - 0 to 10 hours post-first plerixafor dose. | Evaluation of Cl/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cl/F was determined from non-compartmental analysis. |
| Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients | Day 5 - 0 to 10 hours post-first plerixafor dose. | Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis. |
| Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor | Day 4 (10 hours post first plerixafor dose) | A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor). |
| Single-dose Half-life of Plerixafor (T1/2) | Day 5 - 0 to 10 hours post-first plerixafor dose. | Evaluation of T1/2 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. T1/2 was determined from non-compartmental analysis. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL) Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. | 8 |
| Multiple Myeloma (MM) Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. | 14 |
| Total | 22 |
Baseline characteristics
| Characteristic | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | Total |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 8.7 | 57.5 years STANDARD_DEVIATION 10.3 | 57.6 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 14 / 14 |
| serious Total, serious adverse events | 1 / 8 | 2 / 14 |
Outcome results
Primary
Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)
Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Time frame: Day 1 to approximately Day 38 (before start of chemotherapy)
Population: Safety population - all participants who received at least 1 dose of plerixafor.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Definitely related) | 2 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Mild) | 4 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Not related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug(Probably related) | 4 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Moderate) | 4 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Probably not related) | 2 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Severe) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Possibly related) | 0 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Moderate) | 6 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Possibly related) | 5 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Mild) | 8 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug(Probably related) | 5 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Definitely related) | 1 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Severe) | 0 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Not related) | 0 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Probably not related) | 3 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Definitely related) | 3 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Mild) | 12 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Moderate) | 10 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Severe) | 0 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Not related) | 0 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Probably not related) | 5 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Possibly related) | 5 participants |
| Total | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug(Probably related) | 9 participants |
Secondary
Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor
A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).
Time frame: Day 4 (10 hours post first plerixafor dose)
Population: Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor | 4.2 ratio |
Secondary
Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells
To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.
Time frame: Time 0 to 11 hours after the first dose of plerixafor
Population: The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).~One participant excluded from the analysis because data was missing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells | ≥ 2-fold Increase | 8 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells | < 2-fold Increase | 0 participants |
| Multiple Myeloma (MM) | Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells | ≥ 2-fold Increase | 13 participants |
| Multiple Myeloma (MM) | Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells | < 2-fold Increase | 0 participants |
| Total | Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells | ≥ 2-fold Increase | 21 participants |
| Total | Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells | < 2-fold Increase | 0 participants |
Secondary
Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant
Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Time frame: 2 months
Population: Intent to treat population of participants who had transplants. One participant received a tandem transplant.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | Day 13 to Day 21 | 1 number of transplants | — |
| Non-Hodgkin's Lymphoma (NHL) | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | ≤ Day 12 | 7 number of transplants | 1.5 |
| Non-Hodgkin's Lymphoma (NHL) | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | ≥ Day 22 | 0 number of transplants | — |
| Multiple Myeloma (MM) | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | Day 13 to Day 21 | 5 number of transplants | — |
| Multiple Myeloma (MM) | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | ≤ Day 12 | 10 number of transplants | 2.8 |
| Multiple Myeloma (MM) | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | ≥ Day 22 | 0 number of transplants | — |
| Total | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | ≤ Day 12 | 17 number of transplants | — |
| Total | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | ≥ Day 22 | 0 number of transplants | — |
| Total | Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant | Day 13 to Day 21 | 6 number of transplants | — |
Secondary
Single-dose Apparent Clearance of Plerixafor (CL/F)
Evaluation of Cl/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cl/F was determined from non-compartmental analysis.
Time frame: Day 5 - 0 to 10 hours post-first plerixafor dose.
Population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Single-dose Apparent Clearance of Plerixafor (CL/F) | 4767 mL/hour | Standard Deviation 1063 |
Secondary
Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients
Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.
Time frame: Day 5 - 0 to 10 hours post-first plerixafor dose.
Population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients | 33668 mL | Standard Deviation 10531 |
Secondary
Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10)
Evaluation of AUC0-10 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. AUC0-10 was determined from non-compartmental analysis.
Time frame: Day 5 - 0 to 10 hours post-first plerixafor dose.
Population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10) | 3594 ng•h/mL | Standard Deviation 697 |
Secondary
Single-dose Half-life of Plerixafor (T1/2)
Evaluation of T1/2 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. T1/2 was determined from non-compartmental analysis.
Time frame: Day 5 - 0 to 10 hours post-first plerixafor dose.
Population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Single-dose Half-life of Plerixafor (T1/2) | 5.1 hours | Standard Deviation 2.2 |
Secondary
Single-dose Maximum Observed Concentration of Plerixafor (Cmax)
Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.
Time frame: Day 5 - 0 to 10 hours post-first plerixafor dose.
Population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Single-dose Maximum Observed Concentration of Plerixafor (Cmax) | 926 ng/mL | Standard Deviation 237 |
Secondary
Single-dose Time to Maximum Concentration of Plerixafor (Tmax)
Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.
Time frame: Day 5 - 0 to 10 hours post-first plerixafor dose
Population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Single-dose Time to Maximum Concentration of Plerixafor (Tmax) | 0.5 hours | Full Range 0.2 |
Secondary
Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment
In a subpopulation of NHL participants, the mobilization of NHL cells was to be evaluated. None of the samples were analyzed due to sample degradation.
Time frame: Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis.
Population: This analysis was not performed due to sample degradation.