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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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:2004-001842-34
    Sponsor's Protocol Code Number:DOXIL-MMY-3001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-05-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-001842-34
    A.3Full title of the trial
    A Randomized Controlled Study of DOXIL/CAELYX (doxorubicin HCL liposome injection) and VELCADE (bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
    A.3.2Name or abbreviated title of the trial where available
    doxil/caelyx plus velcade versus velcade alone in relapse multiple myeloma
    A.4.1Sponsor's protocol code numberDOXIL-MMY-3001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJohnson&Johnson Pharmaceutical Research and Development, Division de Janssen-Cilag
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Caelyx 2 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameDOXIL/CAELYX 50mg vial/2 mg/ml
    D.3.2Product code Doxorubicin HCL Liposome Injection
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdoxorubicin hydrochloride
    D.3.9.3Other descriptive namepegylated liposomal doxorubicin hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Velcade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameVELCADE 3.5 mg powder for solution for injection
    D.3.2Product code PS-341
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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.3.9.3Other descriptive nameBoronic Acid: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Recurred or relapsed multiple myeloma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to test the hypothesis that treatment with DOXIL/CAELYX and VELCADE in combination, will result in a longer time to progression (TTP) than VELCADE monotherapy in subjects with relapsed multiple myeloma.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare the treatment groups for: overall survival (OS);response rate (complete + partial) using standard criteria; and safety profiles. In addition, the 2 treatment groups will be evaluated for: the impact of the treatment on the subject-reported outcomes and the impact on health economic parameters to include utilization of hospital resources and medications, and to explore the possible relationship between anthracycline dose, cardiac events, and genes that may increase the likelihood of anthracycline-induced cardiac toxicity, and the pattern of RNA expression in plasma multiple myeloma cells from bone marrow prior to the start of treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Male or female and at least 18 years-of-age
    - Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
    - Progressive Disease after an initial response (complete, partial, or minimal) to at least 1 line of therapy, which includes at a minimum an alkylating agent or anthracycline and corticosteroids
    A single line of therapy may consist of one or more cytotoxic drugs such as melphalan plus prednisone; vincristine plus doxorubicin (or DOXIL/CAELYX) plus dexamethasone; or high-dose pulse corticosteroid.
    A single line of therapy may include hematopoietic stem cell transplantation plus maintenance treatment as well as induction with VAD or another regimen
    or
    Progressing during initial therapy that included, at a minimum, an alkylating agent and corticosteroids
    - Progressive disease as defined by one of the following:
    >25% increase in M-protein
    Development of new or worsening lytic bone lesions, plasmacytoma or hypercalcemia (>11.5 mg/dL corrected) despite appropriate medical treatment
    - Measurable secretory disease defined as either:
    Quantifiable serum monoclonal antibody defined as a serum monoclonal protein >1 g/dL for immunoglobulin G (IgG), >0.5 g/dL for immunoglobulin A (IgA), or > 0.05 g/dL of immunoglobulin D (IgD)
    Measurable urine levels of monoclonal protein (>200mg/24 hours)
    - ECOG performance status of 0 or 1
    - Life expectancy of at least 3 months
    - At randomization hematologic values within the following limits
    Absolute neutrophil count (ANC) > or =1,000/mm3
    Platelet count > or =75,000/mm3 without transfusion support for 7 days prior to study
    Hemoglobin > or =8.0 g/dL without transfusion support for 7 days prior to study entry
    - At screening serum biochemical values within the following limits
    Calculated (Cockroft-Gault formula) or measured creatinine clearance of > or =30 mL/minute, whichever is greater
    Total bilirubin < or =1.5 x upper limit of normal (ULN)
    Transaminases (AST/ALT) < or =2.5 x ULN
    - At randomization a corrected serum calcium <12 mg/dL (3.0 mM/L). This level may be achieved by treatment but it must be reached before the subject may be randomized
    - Left ventricular ejection fraction (LVEF) within institutional normal limits
    - Recovered from the acute toxicity of any prior treatment
    - Female subjects must be postmenopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the study
    - Negative serum or urine beta-hCG pregnancy test at screening for subjects of child-bearing potential
    - Able to respond to health outcomes questionnaire
    - Subjects must have signed an informed consent document
    - Subjects must have signed an informed consent for genetic testing. Participation in the genetic testing component is not mandatory for participation in the study.
    - Subject is, in the investigator's opinion, able and willing to comply with the protocol requirements
    E.4Principal exclusion criteria
    - History of treatment with VELCADE
    - Progressive disease while receiving an anthracycline containing regimen
    - No change (NC) in disease status during initial therapy (Attachment 1: Response Criteria)
    - Non-secretory disease (i.e., no measurable paraprotein in serum or urine; urine paraprotein level < or = 200 mg/24 hours).
    - Prior treatment with doxorubicin, or equivalent, at cumulative doses in excess of 240 mg/m2 (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
    - Peripheral neuropathy of Grade 2 or greater severity as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
    - Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure (Attachment 7), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
    - Treatment with nitrosoureas within 6 weeks
    - Treatment with chemotherapy (other than nitrosoureas), clarithromycin, or radiation therapy within 21 days before randomization
    - Treatment with immuno- or antibody therapy within 60 days before randomization
    - Treatment with plasmapheresis within 30 days before enrollment
    - Major surgery within 30 days before Day 1 Cycle 1 except for minimally invasive procedures such as kyphoplasty
    - Palliative radiation or surgery within 30 days prior to screening
    - Allergic reactions to compounds containing boron, mannitol or doxorubicin, or other components of DOXIL/CAELYX or VELCADE
    - Treatment for a malignant condition, other than multiple myeloma, within the 5 years prior to enrollment; except for basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or cervical cancer in situ within the past 5 years
    - Seropositive for HIV, or active hepatitis A, B, or C infection
    - Poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study
    - Pregnant or breast-feeding
    - Currently enrolled in another clinical research study or less than 30 days since receiving treatment on a research study (patients participating in studies unrelated to their cancer may be enrolled after consultation with and approval by the sponsor)
    - Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the time to progression (TTP) defined as the interval between the date of randomization and the date of disease progression or death due to progression. Subjects who die without documented progression will be censored at the date of their last evaluation. Subjects who are progression-free at the time of data cutoff for an analysis will be censored for TTP at the time of their last tumor assessment. The date of progressive disease (PD) will be determined as the date of the first indication of progression, e.g., sufficient elevation of M-protein, a new skeletal event, using the criteria of EBMT Relapse and Progressive Disease Criteria
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    For the analysis of efficacy, the sponsor will establish a clinical cutoff date after the required number of events (460) for the final analyses of TTP have occurred.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 630
    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 Decision2005-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-05
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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