PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

Sobi

Status and phase

Completed

Phase 4

Conditions

Multiple Myeloma

Non-Hodgkin's Lymphoma

Treatments

Drug: Kepivance (Palifermin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00352703

20050100

Details and patient eligibility

About

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.

Enrollment

145 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.