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An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Multiple Myeloma

Thank you

Trial Information

An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).

Outcome Description:

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 Time Frame:

Up to 40 days

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Biovitrum AB

Authority:

Spain: Ministry of Health and Consumption

Study ID:

20050100

NCT ID:

NCT00352703

Start Date:

April 2006

Completion Date:

May 2007

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • Oral mucositis
  • Non-Hodgkin's lymphoma (NHL)
  • conditioning chemotherapy
  • autologous PBSCT
  • multiple myeloma (MM)
  • Melphalan
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Stomatitis
  • Mucositis

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