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    Summary
    EudraCT Number:2010-018494-37
    Sponsor's Protocol Code Number:HOVON108MM
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2010-08-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-018494-37
    A.3Full title of the trial
    A randomized phase II study for evaluation of T cell depleted non myeloablative allogeneic stem cell transplantation followed by early consolidation with lenalidomide or lenalidomide combined with bortezomib and subsequent DLI for patients with multiple myeloma in progression or relapse following first line therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the effect of donor stem cell transplantation followed by treatment with lenalidomide or lenalidomide with bortezomib and subsequent DLI for patients with a relapse or progression following first line therapy
    A.3.2Name or abbreviated title of the trial where available
    HO108 MM
    A.4.1Sponsor's protocol code numberHOVON108MM
    A.5.4Other Identifiers
    Name:European Myeloma Network nr 05Number:EMN05
    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 SponsorHOVON Foundation
    B.1.3.4CountryNetherlands
    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 supportHOVON Foundation
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportDutch Cancer Society
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOVON
    B.5.2Functional name of contact pointHOVON Data Center
    B.5.3 Address:
    B.5.3.1Street AddressGroene Hilledijk 301
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3075 EA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031(0)107041560
    B.5.5Fax number0031(0)107041028
    B.5.6E-mailhdc@erasmusmc.nl
    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.2.5The 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 namebortezomib
    D.3.4Pharmaceutical form Powder 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 INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Patients, 18-65 years, inclusive, multiple myeloma with a first relapse or progression after first line therapy (with a HLA- identical sibling or unrelated donor completely matched (10/10))
    E.1.1.1Medical condition in easily understood language
    Patients, 18-65 years, inclusive, myeloma with a first relapse or progression after first line therapy (with an appropriate sibling or unrelated donor)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma after first line therapy who are at least in PR after reinduction therapy
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of early consolidation as determined by response and number of patients that receive subsequent DLI.
    • To assess the overall efficacy of the regimen as determined by response rate (especially CR), progression free survival and overall survival.
    • To evaluate quality of life with these regimens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with multiple myeloma with a first relapse or with progression after first line therapy;
    • Relapsed or progressive patients have received reinduction therapy before entering this trial;
    • At least PR after reinduction treatment;
    • 18-65 years,inclusive;
    • HLA-identical sibling or unrelated donor completely matched (10/10) (excluding identical twins);
    • WHO-performance status 0-2;
    • Written informed consent.
    E.4Principal exclusion criteria
    • No previous Allo-SCT;
    • Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
    • Severe neurological or psychiatric disease;
    • Patients with neuropathy, CTC grade 3 or higher;
    • Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times upper limit of normal);
    • Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
    • Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
    • History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or or carcinoma “in situ” of the cervix or breast;
    • Patient known to be HIV-positive;
    • Patients with brain disease with the exception of those patients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months;
    • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or borium;
    • Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential;
    • Not able and not willing to use adequate contraception during therapy;
    • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
    • Severe cardiac dysfunction (NYHA classification II-IV, see appendix E).
    E.5 End points
    E.5.1Primary end point(s)
    Failure free duration (FFD) at 9 months post-transplant. Patients count as a failure (= event) at the earliest time point at which any of the following events occurs within 9 months after Allo-SCT :
    - Onset of acute GvHD grade 3-4 without prior DLI;
    - Onset of extensive chronic GvHD without prior DLI;
    - Non-hematological toxicity CTCAE grade 4;
    - Systemic therapy for uncontrolled myeloma other than the assigned study treatment of lenalidomide or lenalidomide/bortezomib and DLI;
    - Death not due to (progression of) MM, which is in fact TRM.
    Patients without a failure within 9 months post Allo-SCT will be censored at 9 months, at the date of progression, or when they go off protocol treatment, whichever comes first.

    E.5.1.1Timepoint(s) of evaluation of this end point
    If the trial was not discontinued early, the final analysis will be performed when complete information is available for all eligible patients in a treatment arm.
    E.5.2Secondary end point(s)
    • Toxicity profile and compliance related to each treatment step and intervals between treatment steps (Allo-SCT, consolidation chemotherapy as well as pre-emptive DLI);
    • Percentage of patients with a pre-emptive DLI within 6-9 months from the date of Allo-SCT;
    • Response, improvement of response and conversion to full donor chimerism during the separate treatment phases (i.e. from Allo-SCT until consolidation; from consolidation to DLI; and after DLI);
    • CR rate;
    • Progression-free survival (PFS; i.e. time from registration until progression, relapse or death, whichever comes first);
    • PFS from Allo-SCT;
    • Overall survival (OS) measured from time of registration;
    • OS from Allo-SCT;
    • The poportion of patients that complete 1, 2 resp. 3 induction cycles;
    • Quality of life as defined by the EORTC QLQ-C30 and QLQ-MY20
    E.5.2.1Timepoint(s) of evaluation of this end point
    If the trial was not discontinued early, the final analysis will be performed when complete information is available for all eligible patients in a treatment arm.
    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 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 No
    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
    The treatment arms will not be compared
    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 concerned8
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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 patient, last visit
    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 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 2010-08-30. 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 state110
    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)
    When the subject has ended the participation he/she will be followed using the standard of care for myeloma patients including routine physical, laboratory and radiographic evalutions.
    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 Decision2010-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-30
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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