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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-4898 | Registry Identifier | ICTRP |
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This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study Duration-Screening-up to 30-day. Intervention and CD34+cells apheresis up-to 8 day. A follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier. Study duration up to 75 days. For treatment phase visit frequency-daily.
The study duration consists of: An up-to 30-day screening, an up-to 8-day intervention and CD34+ cells apheresis and a follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plerixafor | Experimental | Participants will receive the first dose of plerixafor by subcutaneous (SC) injection on the evening of Day 4 (10 to 11 hours (± 1 hour) prior to the start of next day's apheresis). For a maximum of 4 days, patients will continue to receive daily plerixafor in the evening, followed by a morning dose of G-CSF and apheresis for up to a maximum of 4 apheresis or until ≥ 6×106 Cluster of differentiation 34 (CD34) + cells/kg were collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plerixafor + G-CSF | Drug | subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days | Day 5 to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 4 or fewer apheresis days | Day 5 to Day 8 | |
| the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 2 or fewer apheresis days | Day 5 to Day 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Sites | China | China |
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| Label | URL |
|---|---|
| LPS16586 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| C088327 | plerixafor |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 4 or fewer apheresis days | Day 5 to Day 8 |
| the number of apheresis days required to reach more than or equal to 6x106 CD34+ cells/kg | Day 5 to Day 8 |
| Peripheral Blood CD34+ count from Day 4 to Day 5 with the venous samples for Fluorescent activated cell sorting analysis obtained on the morning of Day 4 prior to administration of G-CSF and morning of Day 5 prior to administration of G-CSF | Day 4 to Day 5 |
| Number of participants with Adverse events and Serious adverse events | Baseline to Day 30 (+7 days) |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |