PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

Multiple Myeloma Clinical Trial

Official title:

An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352703
• Other study ID #: 20050100
• 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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Mucositis
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin's Lymphoma

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

External Links

•   FDA-approved Drug Labeling