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This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kepivance (palifermin) 60 μg/kg/day IV | Experimental | 60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kepivance (Palifermin) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4). | The study consisted of a screening period of up to 42 days to determine subject eligibility, followed by a treatment period of a maximum of 40 days. | Up to 40 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Biovitrum AB | Study Director |
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| Label | URL |
|---|---|
| FDA-approved Drug Labeling | View source |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D051523 | Fibroblast Growth Factor 7 |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |