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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00352703
Other study ID # 20050100
Secondary ID
Status Completed
Phase Phase 4
First received July 13, 2006
Last updated October 31, 2014
Start date April 2006
Est. completion date May 2007

Study information

Verified date October 2014
Source Swedish Orphan Biovitrum
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health and Consumption
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date May 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT

- =Age 18 years

- ECOG performance status <= 2. In the MM group, ECOG status >2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture)

- Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) = 60% of predicted

- Left ventricular ejection fraction (LVEF) = 50%

- Minimum of 1.5 x 10^6 CD34+ cells/kg for autologous transplantation

- Adequate haematological function (ANC = 1.5 x 10^9/L and platelet count = 100 x 10^9/L)

- Serum creatinine <= 2.0 mg/dL

- Total bilirubin <= 2 mg/dL

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 4.0 x IULN

- Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment

- Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. Exclusion Criteria:

- History of or concurrent cancer other than NHL or MM

- Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2)- Prior autologous or allogeneic transplants

- Oral abnormalities defined as baseline oral assessment of WHO grade >0

- Other investigational procedures are excluded

- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)

- Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding

- Subject is not using adequate contraceptive precautions

- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)

- Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products

- Subject has previously been treated on this study or with other keratinocyte growth factors

- Unwilling or unable to complete the patient-reported outcome questionnaires

- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
Kepivance (Palifermin)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Swedish Orphan Biovitrum

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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