Lymphoma, Non-Hodgkin, Multiple Myeloma
Conditions
Keywords
Non-Hodgkin's Lymphoma, Multiple Myeloma, Stem cell mobilization
Brief summary
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
Detailed description
An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared. 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
G-CSF and plerixafor were administered as described in the treatment arms.
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(Abbreviated List): * MM in first partial response/complete response, first relapse, or second partial/complete response * NHL in first or second partial or complete remission * NHL patients who do not have bone marrow involvement and \< 10% for follicular involvement * MM patients who have stable disease with \< 40% bone marrow involvement * No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * White blood cell count (WBC) \>3.0 x 10\^9/L * Absolute neutrophil count \>1.5 x 10\^9/L * Platelet count \>100 x 10\^9/L
Exclusion criteria
(Abbreviated List): * Brain metastases or carcinomatous meningitis * Hypercalcaemia \[\>1 mg/dl above the upper limit of normal (ULN)\] * Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias * Acute Infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | 13 months | Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | Days 4-5 (first dose of plerixafor to apheresis) | The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL). |
| Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) 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. |
Countries
United States
Participant flow
Recruitment details
Patients with NHL or MM eligible for the study were recruited from 5 centers in the United States. The first patient was enrolled (signed informed consent) in April 2004 and the last patient's last study visit was July 2006.
Pre-assignment details
Forty-four participants were enrolled; four participants never received plerixafor treatment so are excluded from summary tables.
Participants by arm
| Arm | Count |
|---|---|
| Non-Hodgkin's Lymphoma (NHL) Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms. | 14 |
| Multiple Myeloma (MM) Participants with multiple myeloma were assigned to any of the 4 treatment arms. | 26 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Period | Death | 1 | 0 |
| Follow-up Period | Final assessment not done | 1 | 3 |
| Treatment Period | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10.8 | 56.1 years STANDARD_DEVIATION 7.6 | 55.6 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 24 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 7 | 6 / 6 | 1 / 1 | 12 / 12 | 9 / 9 | 1 / 1 | 2 / 4 |
| serious Total, serious adverse events | 1 / 7 | 0 / 6 | 0 / 1 | 2 / 12 | 2 / 9 | 0 / 1 | 1 / 4 |
Outcome results
Primary
Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
Time frame: 13 months
Population: Safety population who received at least one dose of plerixafor.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 7 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 2 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 2 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 2 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 3 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 3 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 3 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 2 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 6 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 5 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 0 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 1 participants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 1 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 3 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 6 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 12 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 3 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 2 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 0 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 3 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 4 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 2 participants |
| Multiple Myeloma (MM): Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 3 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 1 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 0 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 5 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 1 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 9 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 2 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 3 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 4 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 3 participants |
| Multiple Myeloma (MM): Plerixafor AM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 2 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 0 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 1 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 0 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 0 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 0 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 1 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 0 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 0 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 0 participants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 1 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 2 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 0 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 0 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 1 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 0 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 3 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 1 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 0 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 0 participants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 2 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably not related) | 6 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Probably related) | 7 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Mild) | 10 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Life Threatening) | 7 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Not related) | 9 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Participants reporting ≥ 1 Adverse Event | 39 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Definitely related) | 8 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Severe) | 14 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Relationship to Drug (Possibly related) | 9 participants |
| All Participants | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | AE Severity (Moderate) | 15 participants |
Secondary
Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Time frame: Days 4-5 (first dose of plerixafor to apheresis)
Population: Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | 2.2 ratio | Standard Deviation 0.8 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | 1.5 ratio | Standard Deviation 0.8 |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | 1.2 ratio | Standard Deviation 0 |
| Multiple Myeloma (MM): Plerixafor PM | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | 1.8 ratio | Standard Deviation 0.4 |
| Multiple Myeloma (MM): Plerixafor AM | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | 6.5 ratio | Standard Deviation 14.7 |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | 24.0 ratio | Standard Deviation 0 |
| Multiple Myeloma (MM): Plerixafor After Chemo | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | 3.1 ratio | Standard Deviation 0 |
Secondary
Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) 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. Six participants with MM had 2 transplants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 0 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 1 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 6 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 2 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 4 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor AM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 0 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 0 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 0 transplants |
| Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 1 transplants |
| Multiple Myeloma (MM): Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 0 transplants |
| Multiple Myeloma (MM): Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 14 transplants |
| Multiple Myeloma (MM): Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 0 transplants |
| Multiple Myeloma (MM): Plerixafor AM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 3 transplants |
| Multiple Myeloma (MM): Plerixafor AM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 9 transplants |
| Multiple Myeloma (MM): Plerixafor AM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 0 transplants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 1 transplants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 0 transplants |
| Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 1 transplants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 0 transplants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 4 transplants |
| Multiple Myeloma (MM): Plerixafor After Chemo | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 0 transplants |