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| ID | Type | Description | Link |
|---|---|---|---|
| MOZ23510 | Other Identifier | Genzyme | |
| 2011-004783-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF alone | Active Comparator | Patients will receive G-CSF for 5 consecutive days |
|
| G-CSF plus plerixafor | Experimental | Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plerixafor | Drug | 240mcg/kg, solution, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells | Peripheral blood parameters | Day 1 to Day 8 of the apheresis/treatment period |
| The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights | Peripheral blood parameters | Day 5 to Day 8 of the apheresis/treatment period |
| The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight | Peripheral blood parameters | Day 5 to Day 8 of the apheresis/treatment period |
| The change in tumor cell mobilization(TCM) in the peripheral blood | Peripheral blood parameters | Day 4 pre-G-CSF to Day 5 pre-G-CSF |
| The number of myeloma tumor cells per patient at each apheresis | Apheresis product parameters | Day 1 to Day 8 of the apheresis/treatment period |
| The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product | Apheresis product parameters | Day 5 to Day 8 of the apheresis/treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| CD34+ stem cell yield in the apheresis product | Day 1 to Day 8 of the apheresis/treatment period | |
| The number of patients that proceed to transplantation | Up to 2 months after final apheresis | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 056002 | Bruges | B-8000 | Belgium | |||
| Investigational Site Number 233001 |
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| Granulocyte-colony stimulating factor (G-CSF) | Drug | 10 mcg/kg, solution, subcutaneous injection |
|
| Overall survival |
| Day 100 post transplant and up to 2 years post first-G-CSF dose |
| Tallinn |
| 13419 |
| Estonia |
| Investigational Site Number 440001 | Vilnius | LT-08661 | Lithuania |
| Investigational Site Number 752001 | Stockholm | 14186 | Sweden |
| Investigational Site Number 752002 | UmeƄ | 901 85 | Sweden |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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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 |
| 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 |
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