PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
Phase 4
Completed
- Conditions
- Non-Hodgkin's LymphomaMultiple Myeloma
- Interventions
- Registration Number
- NCT00352703
- Lead Sponsor
- Swedish Orphan Biovitrum
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Kepivance (palifermin) 60 μg/kg/day IV Kepivance (Palifermin) 60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation.
- Primary Outcome Measures
Name Time Method The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4). Up to 40 days 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.
- Secondary Outcome Measures
Name Time Method