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) - The effect of palifermin on OM induced by high-dose chemotherapy

Amgen0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•- Multiple myeloma subjects scheduled to receive high-dose Melphalan (200 mg/m2 or 140 mg/m2), in a one day schedule (day -2) followed by PBSCT (day 0)
•- Age >=18 and <= 70 years
•- BMI <= 35
•- ECOG performance status <= 2, or an ECOG status of 3 if the reason is due exclusively due to MM
•- DLCO >= 60%
•- Minimum of 2.0 x 10(6) CD34+ cells/kg collected for autologous transplantation
•- Adequate hematological function (ANC >= 1.5 x 10(9)/l and platelet count >=100 x 10(9)/l )
•- Total bilirubin <= 2 mg/dl
•- AST and/or ALT <= 4.0 x IULN
•- Negative serum or urine pregnancy test

•- History of concurrent malignancy other than MM (exception: curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy, without evidence of disease > 3 years)
•- Prior treatment with palifermin, or other fibroblast or keratinocyt growth factors
•- Prior autologous or allogeneic transplants
•- Oral abnormalities defined as baseline oral assessment of WHO > 0
•- Receiving dialysis
•- Twenty-eight days or less between receiving any other investigational drug or device and randomization in this study

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