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    Summary
    EudraCT Number:2006-003709-15
    Sponsor's Protocol Code Number:20050219
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2006-003709-15
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing two different dosing regimens of palifermin (before
    and after chemotherapy versus before chemotherapy) with placebo on
    the effect of reducing oral mucositis in patients with multiple myeloma
    who have been given treatment with high dose melphalan followed by
    stem cell transplantation.
    A.4.1Sponsor's protocol code number20050219
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00434161
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSwedish Orphan Biovitrum AB (publ)
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSwedish Orphan Biovitrum AB (publ)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSwedish Orphan Biovitrum AB (publ)
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressTomtebodavägen 23 A
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-11276
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 8697 20 00
    B.5.5Fax number+468697 23 30
    B.5.6E-mailclinical@sobi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kepivance
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepalifermin
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPalifermin
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral Mucositis Induced by High Dose Chemotherapy

    Cataract development associated with palifermin administration
    E.1.1.1Medical condition in easily understood language
    Oral mucositis (soreness, dryness and inflammation of the mouth) which is a common side effect of certain cancer treatments (such as chemotherapy and radiotherapy).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10007739
    E.1.2Term Cataract
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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)
    Primary Cataract Evaluation Objectives:
    To assess cataract development or progression at month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System III (LOCS III) score for either posterior subcapsular cataract (P), cortical cataract (C), or nuclear opalescence (NO) (Chylack LT et al 1993).
    E.2.2Secondary objectives of the trial
    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)
    Cataract Eval Objectives - To assess:
    -effect of palifermin on the change of posterior subcapsular cataract (P) using the Lens Opacities Classification System III (LOCS III) score.
    -effect of palifermin on the change of cortical cataract (C) using the Lens Opacities Classification System III (LOCS III) score.
    -effect of palifermin on the change of nuclear opalescence (NO) using the Lens opacities Classification System III (LOCS III) score.
    -effect of palifermin on the incidence of decreased best corrected visual acuity (BCVA) from the baseline BCVA on the ETDRS (“Early Treatment Diabetic Retinopathy Study”) chart, (Ferris III FL et al 1982, Ferris III FL et al 1993, Ferris III FL et al, 1996, Ferris III FL, Sperduto RD 1982).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2 if creatinine clearance ≥ 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 ≥ 18 years and ≤ 70 years
    • BMI ≤ 35
    • ECOG performance status ≤ 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) ≥ 50% of predicted
    • Minimum of 2.0 x 106 CD34+ cells/kg collected for autologous transplantation
    • Adequate hematological function (ANC ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L)
    • Total bilirubin ≤ 2 mg/dL
    • Aspartate aminotransferase (AST) and/or 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

    Cataract specific:
    All subjects eligible for 20050219 will also be assessed for their eligibility for cataract
    assessment procedures. If a subject is not eligible for cataract assessment procedures, or the site has a waiver from Amgen regarding cataract assessments, the subject may still be eligible for inclusion in the study but will be exempt from the cataract assessments.
    • Subjects at minimum with a baseline best corrected visual acuity (BCVA) of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS chart in one eye
    • Subject at minimum with one eye with a natural, intact lens
    • Subject who has a LOCS III score at baseline of P < 1.0, C < 2.0 and NO < 2.0
    (in at least one eye)
    E.4Principal 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
    • Currently active infection of oral mucositis
    • 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)
    • 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
    • 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

    Cataract specific:
    • History of cataract surgery in both eyes
    • Incapable of being responsive to midriatic agents (minimum of approximately a 6
    mm pupil required)
    • History of other ocular disease leading to visual loss (e.g., macular degeneration,
    glaucoma, corneal disease) that would make assessment of visual status difficult
    • Subject is scheduled to undergo cataract surgery
    • Subject with any disease, that in the opinion of the ophthalmologist, could
    adversely effect the subject’s vision during the course of the study
    E.5 End points
    E.5.1Primary end point(s)
    Maximum severity of oral mucositis (WHO grades 0/1, 2, 3 or 4)

    Cataract specific endpoints:
    Incidence of cataract development or progression at month 12, based on an increase from baseline of ≥ 0.3 in the LOCS III score for any of posterior
    subcapsular cataract (P), cortical cataract (C), or nuclear opalescence
    (NO).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum severity of oral mucositis: oral cavity assessments daily from high dose melphalan administration throughout hospitalization. Following hospital discharge 3 x weekly assessments until OM grade ≤1. Cataract assessments were done at baseline, month 6 and month 12.
    E.5.2Secondary end point(s)
    -Incidence of ulcerative oral mucositis (WHO grades 2, 3 or 4)

    -Duration of ulcerative oral mucositis (WHO grades 2, 3 and 4)

    -Incidence of severe oral mucositis (WHO grades 3 and 4)

    -Duration of severe oral mucositis (WHO grades 3 and 4)

    -Area under the curve (AUC) for patient-reported MTS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Oral cavity assessments daily from high dose melphalan administration throughout hospitalization. Following hospital discharge 3 x weekly assessments until OM grade ≤1.

    Patient Reported Outcome questionnaires:

    OMDQ: administered at screening and then daily from high-dose Melphalan administration throughout hospitalization. Upon discharge the OMDQ questionnaire administered 3 x weekly until OM grade ≤ 1. The OMDQ also administered at the end of study visit.

    EQ-5D: administered at screening and then weekly on approximately day 7, day 14 & day 21, and end of study.

    FACT-E and MCSQ: administered at screening, end of study, and at day
    60-100 & month 6.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health Economics
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Subjects will undergo an evaluation for the end of study visit at least 30 days after the last administration of investigational product (Day + 32)
    All subjects will be followed for disease progression, second primary tumors, additional malignancies and survival until death or for a minimum of 2 years.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 239
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-10-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 275
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    According to medical needs.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-15
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