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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-004928-21
    Sponsor's Protocol Code Number:Auto-Allo-TSCTinMM
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-004928-21
    A.3Full title of the trial
    Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy with Thalidomide / DLI for patients with Multiple Myeloma (MM) and age <= 60 years: A phase II-study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stem Cell Transplantation and Maintenance Therapy with Thalidomide / DLI for patients with Multiple Myeloma
    A.3.2Name or abbreviated title of the trial where available
    Auto-Allo-TSCT in MM with Thalidomide
    A.4.1Sponsor's protocol code numberAuto-Allo-TSCTinMM
    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 SponsorUniversity Medical Center Hamburg-Eppendorf
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Hamburg-Eppendorf
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Hamburg-Eppendorf
    B.5.2Functional name of contact pointCoordinating Principal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressMartinistr. 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number+4940741054850
    B.5.5Fax number+4940741053795
    B.5.6E-mailnkroeger@uke.uni-hamburg.de
    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 Thalidomid Celgene
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/047
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHALIDOMIDE
    D.3.9.1CAS number 50351
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Myeloma Stage II or III according to Salmon and Durie
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma is a type of blood cancer that affects the plasma cells. In multiple myeloma, malignant plasma cells accumulate in the bone marrow.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Event-free survival four years after auto-allo tandem-transplantation and maintenance therapy with thalidomide in comparison to those patients without a suitable donor, who will receive tandem autologous stem cell transplantation followed by thalidomide maintenance therapy.
    Any of the following occurrences will be considered an endpoint event:
    •recurrence or progression of the primary disease,
    •disease related mortality, or
    •treatment related mortality.
    E.2.2Secondary objectives of the trial
    •Incidence of acute graft-versus-host disease on day +100 after allogeneic stem cell trans¬plantation according to the acc. to the Glucksberg scale revised by Przepiorka et al.
    •Incidence of chronic graft-versus-host disease according to the revised Seattle criteria of Lee et al. at one and two years after allogeneic stem cell transplantation.
    •Toxicity of conditioning and of maintenance therapy according to adverse events according to the reporting guidelines as per NCI CTCAE
    •Cumulative incidence of relapse at four years after auto-allo and auto-auto stem cell transplantation.
    •Disease related mortality at four years after allogeneic stem cell transplantation.
    •Treatment related mortality at four years after allogeneic stem cell transplantation.
    •Overall survival at four years after allogeneic stem cell transplantation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Multiple Myeloma Stage II or III according to Salmon and Durie (see Protocol Appendix ‎30.5 on page 75)
    • Patient's age: 18 – 60 years.
    • Patient's written informed consent.
    • Compliance with “Thalidomide Pregnancy Prevention Plan for Subjects in Clinical Trials” (see Protocol Appendix 30.14 on page 118); becoming effective with protocol version August 27, 2015.
    • A maximum of eight chemotherapy cycles prior to registration (CR / PR / MR / or PD).(Melphalan containing regimen should be avoided as induction therapy)
    E.4Principal exclusion criteria
    •More than eight chemotherapy cycles prior to registration.
    •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
    •Total bilirubin, SGPT or SGOT > 3 times upper the normal level.
    •Left ventricular ejection fraction < 30 %.
    •Creatinine clearance < 30 ml/min.
    •DLCO < 35 % and/or receiving supplementary continuous oxygen.
    •Positive serology for HIV.
    •Pregnant or lactating women.
    •Participation in another trial at time of registration.
    •No HLA-identical or compatible related or unrelated donor (HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1) (one mismatch allowed).
    •Preceding autologous stem cell transplantation.
    •Age > 61 years.
    E.5 End points
    E.5.1Primary end point(s)
    Event-free survival four years after auto-allo tandem-transplantation and maintenance therapy with thalidomide in comparison to those patients without a suitable donor, who will receive tandem autologous stem cell transplantation followed by thalidomide maintenance therapy. Any of the following occurrences will be considered an endpoint event:
    •recurrence or progression of the primary disease,
    •disease related mortality, or
    •treatment related mortality.
    E.5.1.1Timepoint(s) of evaluation of this end point
    four years after auto-allo tandem-transplantation
    E.5.2Secondary end point(s)
    • Incidence of acute graft-versus-host disease on day +100 after allogeneic stem cell trans-plantation according to the acc. to the Glucksberg scale revised by Przepiorka et al..
    • Incidence of chronic graft-versus-host disease according to the revised Seattle criteria of Lee et al. at one and two years after allogeneic stem cell transplantation.
    • Toxicity of conditioning and of maintenance therapy according to adverse events according to the reporting guidelines as per NCI CTCAE.
    • Cumulative incidence of relapse at four years after auto-allo and auto-auto stem cell transplantation.
    • Disease related mortality at four years after allogeneic stem cell transplantation.
    • Treatment related mortality at four years after allogeneic stem cell transplantation.
    • Overall survival at four years after allogeneic stem cell transplantation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    four years after allogeneic stem cell transplantation except chronic graft-versus-host disease (one and two years after allogeneic stem cell transplantation) and acute graft-versus-host disease (on day +100 after allogeneic stem cell trans-plantation)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No maintenance Therapy with Thalidomide
    E.8.2.4Number of treatment arms in the trial2
    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 concerned24
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    Last Folow-up visit of the last patient (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 220
    F.1.3Elderly (>=65 years) No
    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 2008-03-28. 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 state220
    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)
    None
    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 Decision2008-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-17
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