A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin Pre- and Post Chemotherapy and Pre-Chemotherapy only for Reduction in Severity of Oral Mucositis in Subjects with Multiple Myeloma MM Receiving High Dose Melphalan followed by Autologous Peripheral Blood Stem Cell Transplantation PBSCT - EU PMC in Heme Tx

Conditions: Mieloma Multiple Subject
MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

Registration Number: EUCTR2006-003709-15-IT

Lead Sponsor: AMGEN S.P.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 275

Inclusion Criteria

- Multiple myeloma MM subjects scheduled to receive high-dose Melphalan 200 mg/m2 if creatinine clearance 8805; 30 mL/min or 140 mg/m2 if creatinine clearance 30 mL/min , in a one day schedule day -2 followed by autologous PBSCT day 0 - Age 8805; 18 years and 8804; 70 years - BMI 8804; 35 - ECOG performance status 8804; 2, or an ECOG status of 3 if the reason for a status of 3 is due exclusively due to MM e.g. pathological fracture - Adequate pulmonary function as measured by a corrected carbon monoxide CO diffusing capacity DLCO 8805; 60 of predicted - Minimum of 2.0 x 106 CD34 cells/kg collected for autologous transplantation - Adequate hematological function ANC 8805; 1.5 x 109/L and platelet count 8805; 100 x 109/L - Total bilirubin 8804; 2 mg/dL - Aspartate aminotransferase AST and/or alanine aminotransferase ALT 8804; 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of or concurrent malignancy other than MM, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy, without evidence of disease for 3 years - Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors eg, KGF-2 - Prior autologous or allogeneic transplants - Oral abnormalities defined as baseline oral assessment of WHO grade 0 - Receiving dialysis - Twenty-eight days or less between receiving any other investigational drug or device and randomization into this study - Subject of child-bearing potential is evidently pregnant eg, positive HCG test or is breast feeding - Subject has not agreed to using adequate contraceptive precautions - Known to be sero-positive for human immunodeficiency virus HIV , hepatitis B virus HBSAg , or hepatitis C virus HCV - 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of palifermin relative to placebo when given either pre- and post-high dose chemotherapy or pre-high dose chemotherapy only with regard to the severity of oral mucositis WHO grades 0/1, 2, 3 or 4 ;Secondary Objective: To assess the effect of palifermin on the incidence and duration of ulcerative oral mucositis WHO grades 2, 3 and 4 and of severe mucositis WHO grades 3 and 4 To evaluate the impact of palifermin on patient-reported mouth and throat soreness MTS ;Primary end point(s): Maximum severity of oral mucositis WHO grades 0/1, 2, 3 or 4

Secondary Outcome Measures