Multiple Myeloma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Oral mucositis, Non-Hodgkin's lymphoma (NHL), conditioning chemotherapy, autologous PBSCT, multiple myeloma (MM), Melphalan
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.
Interventions
DRUGKepivance (Palifermin)
Sponsors
Swedish Orphan Biovitrum
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed