Lymphoma, Non-Hodgkin, Multiple Myeloma
Conditions
Keywords
Non-Hodgkin's Lymphoma, Multiple Myeloma, Stem cell mobilization
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. The number of apheresis sessions required to obtain ≥ 5\*10\^6 CD34+ cells will also be measured. Success of the transplantation(s) will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMN) and platelets (PLT). Participants will be followed for durability of their transplant for 12 months following transplantation. 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
AnorMED
Genzyme, a Sanofi Company
Study design
Allocation
NON_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 175% of their ideal body weight * 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 (approximately day 38). 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 Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | Days 4-5 (first dose of plerixafor to apheresis) | The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median Cumulative Number of CD34+ Cells Collected During Apheresis | Days 5-8 | Median cumulative total number of CD34+ cells collected during apheresis. |
| Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | 2 months | Participants were monitored for platelet (PLT) 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. |
| Number of Participants With Durable Engraftment 12 Months After Transplantation | Approximately 13 months (12 months post-transplant ) | The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts. |
Countries
United States
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. | 23 |
| 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. | 26 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 1 | 2 |
Baseline characteristics
| Characteristic | Non-Hodgkin's Lymphoma (NHL) | Multiple Myeloma (MM) | Total |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 8.7 | 57.6 years STANDARD_DEVIATION 8.1 | 57.1 years STANDARD_DEVIATION 8.3 |
| Race/Ethnicity, Customized African-American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 23 participants | 23 participants | 46 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 23 | 26 / 26 |
| serious Total, serious adverse events | 0 / 23 | 1 / 26 |
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 (approximately day 38). 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 Severity (Severe) | 10 participants |
| 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 Relationship to Drug (Probably Not Related) | 1 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) | Participants reporting ≥ 1 Adverse Event | 23 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) | 8 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Moderate) | 5 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Mild) | 8 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) | 12 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Not Related) | 4 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | Participants reporting ≥ 1 Adverse Event | 26 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Mild) | 9 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Moderate) | 2 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Severe) | 15 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Probably Not Related) | 4 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 Relationship to Drug (Probably Related) | 11 participants |
| Multiple Myeloma (MM) | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Definitely Related) | 2 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Moderate) | 7 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | Participants reporting ≥ 1 Adverse Event | 49 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Possibly Related) | 17 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Mild) | 17 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Definitely Related) | 4 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Not Related) | 4 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Severity (Severe) | 25 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Probably Related) | 19 participants |
| All Participants | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | AE Relationship to Drug (Probably Not Related) | 5 participants |
Secondary
Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor
The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase 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: The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | ≥ 2-fold Increase | 20 participants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | < 2-fold Increase | 3 participants |
| Multiple Myeloma (MM) | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | ≥ 2-fold Increase | 17 participants |
| Multiple Myeloma (MM) | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | < 2-fold Increase | 9 participants |
| All Participants | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | ≥ 2-fold Increase | 37 participants |
| All Participants | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | < 2-fold Increase | 12 participants |
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: Participants who received a transplant. Two participants in the MM group received a second transplant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | 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 number of transplants |
| Non-Hodgkin's Lymphoma (NHL) | 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 | 19 number of transplants |
| Non-Hodgkin's Lymphoma (NHL) | 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 number of transplants |
| Multiple Myeloma (MM) | 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 | 7 number of transplants |
| Multiple Myeloma (MM) | 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 | 20 number of transplants |
| Multiple Myeloma (MM) | 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 number of transplants |
| All Participants | 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 | 39 number of transplants |
| All Participants | 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 number of transplants |
| All Participants | 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 | 10 number of transplants |
Other Pre-specified
Median Cumulative Number of CD34+ Cells Collected During Apheresis
Median cumulative total number of CD34+ cells collected during apheresis.
Time frame: Days 5-8
Population: Participants who received at least one dose of plerixafor
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Median Cumulative Number of CD34+ Cells Collected During Apheresis | 5.2 CD34+ cells (*10^6 / kg) |
| Multiple Myeloma (MM) | Median Cumulative Number of CD34+ Cells Collected During Apheresis | 11.1 CD34+ cells (*10^6 / kg) |
| All Participants | Median Cumulative Number of CD34+ Cells Collected During Apheresis | 5.9 CD34+ cells (*10^6 / kg) |
Other Pre-specified
Number of Participants With Durable Engraftment 12 Months After Transplantation
The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.
Time frame: Approximately 13 months (12 months post-transplant )
Population: Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Number of Participants With Durable Engraftment 12 Months After Transplantation | 21 participants |
| Multiple Myeloma (MM) | Number of Participants With Durable Engraftment 12 Months After Transplantation | 22 participants |
| All Participants | Number of Participants With Durable Engraftment 12 Months After Transplantation | 43 participants |
Other Pre-specified
Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Participants were monitored for platelet (PLT) 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: A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 10 number of transplants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 7 number of transplants |
| Non-Hodgkin's Lymphoma (NHL) | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 5 number of transplants |
| Multiple Myeloma (MM) | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 18 number of transplants |
| Multiple Myeloma (MM) | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 7 number of transplants |
| Multiple Myeloma (MM) | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 1 number of transplants |
| All Participants | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≤ Day 12 | 14 number of transplants |
| All Participants | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | ≥ Day 22 | 6 number of transplants |
| All Participants | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Day 13 to Day 21 | 28 number of transplants |