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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   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:2019-001413-16
    Sponsor's Protocol Code Number:68284528MMY3002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-02
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001413-16
    A.3Full title of the trial
    A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma

    Studio randomizzato di fase 3 per confrontare JNJ-68284528, una terapia a base di cellule T che esprimono un recettore chimerico per l'antigene (CAR-T) anti BCMA, rispetto alle combinazioni Pomalidomide, Bortezomib e desametasone (PVd) o Daratumumab, Pomalidomide e desametasone (DPd) in soggetti con Mieloma Multiplo recidivo e refrattario alla Lenalidomide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Study Comparing JNJ-68284528 versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma
    Studio randomizzato di fase 3 per confrontare JNJ-68284528 rispetto alle combinazioni Pomalidomide, Bortezomib e desametasone (PVd) o Daratumumab, Pomalidomide e desametasone (DPd) in soggetti con Mieloma Multiplo recidivo e refrattario alla Lenalidomide
    A.3.2Name or abbreviated title of the trial where available
    CARTITUDE-4
    CARTITUDE-4
    A.4.1Sponsor's protocol code number68284528MMY3002
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen Cilag SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 No
    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 nameJNJ-68284528
    D.3.2Product code [JNJ-68284528]
    D.3.4Pharmaceutical form Dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ-68284528
    D.3.9.3Other descriptive nameD.3.6.2.1 - valore: 0.75 x 10^6 CAR-positive viable T cells/kg D.3.6.2.2 - unità: cells X kg D.3.10.2.1.1 - valore concentrazione: 0.5 x 10^6 - 1.0 x 10^6
    D.3.9.4EV Substance CodeSUB197280
    D.3.10 Strength
    D.3.10.1Concentration unit kg kilogram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500000 to 1000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Yes
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberL'EMA / CAT ritiene che il prodotto JNJ-68284528 rientri nella definizione di medicinale per terapia genica. Rif. Prodotto: H0005095
    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 Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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 No
    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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab
    D.3.2Product code [JNJ-54767414]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 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.IMP: 3
    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 Yes
    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 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 namebortezomib
    D.3.2Product code [bortezomib]
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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.3.9.2Current sponsor codeBORTEZOMIB
    D.3.9.3Other descriptive nameD.3.6.2.1 - valore : 1.3 nei giorni 1,4,8,11 per i primi 8 cicli; ciclo dal 9 in poi: giorno 1 e 8 D.3.10.2.1.1 - valore concentrazione: 2.5
    D.3.9.4EV Substance CodeSUB20020
    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) No
    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 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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name IMNOVID
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    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 nameIMNOVID
    D.3.2Product code [IMNOVID]
    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 INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codePOMALIDOMIDE
    D.3.9.3Other descriptive nameD.3.6.2.1 - valore: 4 (riduzione della dose di 1,2,3 mg consentita come specificato nel protocollo)
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 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.IMP: 5
    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 Yes
    D.2.1.1.1Trade name IMNOVID
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    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 nameIMNOVID
    D.3.2Product code [IMNOVID]
    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 INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codePOMALIDOMIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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.IMP: 6
    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 Yes
    D.2.1.1.1Trade name IMNOVID
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    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 nameIMNOVID
    D.3.2Product code [IMNOVID]
    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 INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeIMNOVID
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) No
    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 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.IMP: 7
    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 Yes
    D.2.1.1.1Trade name IMNOVID
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    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 nameIMNOVID
    D.3.2Product code [IMNOVID]
    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 INNPOMALIDOMIDE
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeIMNOVID
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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 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.IMP: 8
    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 Yes
    D.2.1.1.1Trade name Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel Munchener Str. 15
    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 nameDexamethasone
    D.3.2Product code [Dexamethasone]
    D.3.4Pharmaceutical form Tablet
    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 INNDESAMETASONE
    D.3.9.2Current sponsor codeDexamethasone
    D.3.9.3Other descriptive nameD.3.6.2.1 - valore : 20 mg al giorno o 10mg al giorno per braccio PVd & dose totale di 40 mg settimanali per il braccio DPd
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 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.IMP: 9
    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 Yes
    D.2.1.1.1Trade name Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDexamethasone
    D.3.2Product code [Dexamethasone]
    D.3.4Pharmaceutical form Tablet
    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 INNDESAMETASONE
    D.3.9.2Current sponsor codeDexamethasone
    D.3.9.3Other descriptive nameD.3.6.2.1 - valore : 20 mg al giorno o 10mg al giorno per braccio PVd & dose totale di 40 mg settimanali per il braccio DPd
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) No
    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 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
    Relapsed and lenalidomide-refractory multiple myeloma (MM)
    Mieloma Multiplo recidivo e refrattario alla Lenalidomide
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma
    Mieloma Multiplo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    To compare the efficacy of JNJ 68284528 with standard therapy, either PVd or DPd
    Confrontare l'efficacia di JNJ 68284528 e della terapia standard, PVd o DPd
    E.2.2Secondary objectives of the trial
    1.To further compare the efficacy of JNJ 68284528 with standard therapy, either PVd or DPd
    2. To assess the safety profile of JNJ 68284528
    3. To characterize the pharmacokinetics and pharmacodynamics of JNJ-68284528
    4. To assess the immunogenicity of JNJ 68284528
    5. To evaluate the impact of JNJ-68284528 treatment on the health-related quality of life of subjects compared with standard therapy, either PVd or DPd
    1. Confrontare l'efficacia di JNJ 68284528 e della terapia standard, PVd o DPd
    2. Valutare il profilo di sicurezza di JNJ 68284528
    3. Caratterizzare la farmacocinetica e la farmacodinamica di JNJ-68284528
    4. Valutare l'immunogenicità di JNJ 68284528
    5. Valutare l'impatto del trattamento JNJ-68284528 sulla qualità della vita correlata alla salute dei soggetti rispetto alla terapia standard, PVd o DPd
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be at least 18 years of age.
    2. Have documented diagnosis of MM as defined by the criteria below:
    -Multiple myeloma diagnosis according to the IMWG diagnostic criteria
    -Measurable disease at screening as defined by any of the following:
    -Serum monoclonal paraprotein (M-protein) level >=1.0 g/dL or urine M-protein level >=200 mg/24 hours; or
    -Light chain MM without measurable M-protein in the serum or the urine: Serum free light chain >=10 mg/dL and abnormal serum free light chain ratio.
    3. Have received 1 to 3 prior lines of therapy including a PI and IMiD. Subject must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy
    4. Have documented evidence of PD by IMWG criteria based on investigator’s determination on or within 6 months of their last regimen.
    5. Subjects with only 1 prior line of therapy must have progressed within 36 months of a stem cell transplant or if not transplanted, then within 42 months of starting initial therapy.
    6. Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For subjects with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy.
    7. Have an ECOG Performance Status score of 0 or 1
    8. Have clinical laboratory values as specified in the protocol.

    For additional information see section 5.1 of the protocol
    1. Età non inferiore a 18 anni.
    2. Diagnosi di MM documentata, secondo quanto definito dai criteri seguenti:
    • Diagnosi di mieloma multiplo in base ai criteri diagnostici del Gruppo di lavoro internazionale sul mieloma (IMWG)
    • Malattia misurabile allo screening definita da uno qualsiasi dei seguenti criteri:
    - Livello di paraproteina (proteina M) monoclonale nel siero >=1,0 g/dL o livello della proteina M nell’urina >=200 mg/24 ore; oppure
    - Mieloma multiplo a catene leggere senza proteina M misurabile nel siero o nell’urina: Catene leggere libere sieriche >=10 mg/dL e rapporto anomalo tra le catene leggere libere sieriche.
    3. Somministrazione avvenuta in precedenza di 1-3 linee di terapia, tra cui un PI e un IMiD. Completamento di almeno un ciclo di trattamento completo per ogni linea di terapia, a meno che la PD non fosse la migliore risposta alla linea di terapia
    4. Evidenza documentata di PD secondo i criteri IMWG sulla base della determinazione dello sperimentazione durante o entro 6 mesi dall’ultimo regime.
    5. Progressione entro 36 mesi dal trapianto di cellule staminali per i pazienti con una sola linea di terapia precedente o, in assenza di trapianto, progressione entro 42 mesi dall’inizio della terapia iniziale.
    6. Refrattarietà a lenalidomide secondo le linee guida di consenso IMWG (mancato raggiungimento di una risposta minima o progressione contestuale o entro i 60 giorni dal completamento della terapia con lenalidomide). La progressione contestuale o entro i 60 giorni dall’ultima dose di lenalidomide somministrata come mantenimento soddisfa tale criterio. Per i soggetti con più di una linea di terapia precedente, non è richiesta la refrattarietà a lenalidomide nella linea di terapia più recente.
    7. Presentare un performance status ECOG di 0 o 1
    8. Valori degli esami di laboratorio come specificato nel protocollo.

    Per informazioni aggiuntive vedere la sezione 5.1 del protocollo.
    E.4Principal exclusion criteria
    1.Prior treatment with CAR-T therapy directed at any target.
    2. Any previous therapy that is targeted to BCMA.
    3. Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia.
    4. Subjects with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive PVd as standard therapy or bridging therapy; however, subject may receive DPd as standard therapy or bridging therapy.
    5. Was vaccinated with live attenuated vaccines within 4 weeks prior to randomization
    6. Subject received any antitumor therapy as specified in the protocol, prior to randomization
    7. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Refer to the protocol for allowed exceptions.
    8. Plasma cell leukemia at the time of screening, Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.
    9.1 Contraindications or life-threatening allergies, hypersensitivity, or intolerance to JNJ 68284528 or its excipients, including dimethylsulfoxide, or to fludarabine, cyclophosphamide, tocilizumab, pomalidomide, dexamethasone.
    - Subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to daratumumab will not be permitted to receive DPd as standard therapy or bridging therapy; however, subjects may receive PVd as standard therapy or bridging therapy. Likewise, subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib will not be permitted to receive PVd as standard therapy or bridging therapy; but may receive DPd as standard therapy or bridging therapy.
    10. Stroke or seizure within 6 months of signing ICF.
    11. Received either of the following:
    -An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Subjects with active graft-versus-host disease are excluded.
    -An autologous stem cell transplantation <= 12 weeks before apheresis.
    12. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.
    For additional information, see section 5.2 of the protocol
    1. Ha precedentemente ricevuto un trattamento con terapia CAR-T per qualsiasi malattia.
    2. Ha precedentemente ricevuto una terapia mirata a BCMA.
    3. Presenta tossicità in corso derivante da una precedente terapia antitumorale che non si è risolta ritornando al livello basale o al grado 1 o inferiore, ad eccezione dell’alopecia.
    4 Presenta una neuropatia periferica di grado 1 associata a dolore o neuropatia periferica di grado 2 o superiore. In questo caso non è consentito somministrare PVd come terapia standard o terapia ponte; tuttavia, è possibile somministrare DPd come terapia standard o terapia ponte.
    5. Ha ricevuto vaccini vivi attenuati nelle 4 settimane precedenti la randomizzazione
    6. Ha ricevuto una terapia antitumorale precedente alla randomizzazione
    7. Neoplasie attive (cioè, in corso o che richiedono una modifica del trattamento negli ultimi 24 mesi) diverse dalla malattia in corso di studio. Per le eccezioni consentite riferirsi al protocollo.
    8. Presenta leucemia delle cellule plasmatiche allo screening, macroglobulinemia di Waldenström, sindrome di POEMS (polineuropatia, organomegalia, endocrinopatia, proteina monoclonale e alterazioni cutanee) o amiloidosi AL primaria.
    9. Presenta controindicazioni o allergie potenzialmente letali, ipersensibilità o intolleranza a JNJ 68284528 o ai relativi eccipienti, incluso il dimetilsolfossido o a fludarabina, ciclofosfamide, tocilizumab, pomalidomide, desametasone.
    I soggetti con controindicazioni o allergie potenzialmente letali, ipersensibilità o intolleranza al daratumumab non potranno ricevere il DPd come terapia standard o terapia ponte; tuttavia, possono ricevere il PVd come terapia standard o terapia ponte. Allo stesso modo, i soggetti con controindicazioni o allergie potenzialmente letali, ipersensibilità o intolleranza al bortezomib non potranno ricevere il PVd come terapia standard o terapia ponte; ma potranno ricevere il DPd come terapia standard o terapia ponte.
    10. Presenta casi di ictus o crisi epilettica nei 6 mesi trascorsi dalla sottoscrizione dell’ICF.
    11. È stato soggetto di uno dei seguenti scenari:
    - Trapianto allogenico di cellule staminali nei 6 mesi precedenti all’aferesi. I soggetti che hanno ricevuto un trapianto allogenico devono interrompere l’assunzione di farmaci immunosoppressori per 6 settimane in assenza di segni di malattia del trapianto contro l’ospite. Sono esclusi i soggetti con malattia del trapianto contro l’ospite attiva.
    - Trapianto autologo di cellule staminali nelle <=12 settimane precedenti all’aferesi.
    12. Coinvolgimento noto attivo o precedente del sistema nervoso centrale (SNC) o manifestazione di segni clinici di coinvolgimento meningeo del MM.

    Per informazioni aggiuntive vedere la sezione 5.2 del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Sopravvivenza libera da progressione (PFS)
    PFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed monthly from randomization until disease progression (PD) or death whichever occurs first (approximately up to 6 years)
    Valutata mensilmente dalla randomizzazione fino alla progressione della malattia (PD) o alla morte, a seconda di quello che accade per primo (circa fino a 6 anni)
    E.5.2Secondary end point(s)
    1. Rate of CR/sCR
    2. Overall MRD negative rate
    3. Rate of MRD negativity in subjects with CR/sCR at 12 months ±3 months
    4. Rate of sustained MRD negative status
    5. OS
    6. ORR
    7. PFS on next line of therapy (PFS2)
    8. Incidence and severity of adverse events
    9. Pharmacokinetic and pharmacodynamic markers including but not limited, to systemic cytokine concentrations, and markers of CAR-T cells, T cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level.
    10. Presence of anti-JNJ-68284528 antibodies
    11. Change from baseline in health-related quality of life (HRQoL) subscale scores from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q), EuroQol Five Dimension Questionnaire (EQ-5D-5L), Patient Global Impression of Severity (PGIS), and the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items.
    1. Tasso di CR / sCR
    2. Tasso negativo MRD complessivo
    3. Tasso di negatività della MRD in soggetti con CR / sCR a 12 mesi ± 3 mesi
    4. Tasso di stato negativo MRD sostenuto
    5. OS
    6. ORR
    7. PFS sulla prossima linea di terapia (PFS2)
    8. Incidenza e gravità degli eventi avversi
    9. Marker farmacocinetici e farmacodinamici, inclusi ma non limitati a, concentrazioni di citochine sistemiche e marker di cellule CAR-T, espansione delle cellule T (proliferazione) e persistenza attraverso il monitoraggio della conta delle cellule CAR-T positive e del livello di transgene CAR.
    10. Presenza di anticorpi anti-JNJ-68284528
    11. Variazione rispetto al basale dei punteggi delle sottoscale sulla qualità della vita (HRQoL) relativi alla salute provenienti dall'Organizzazione europea per la ricerca e il trattamento del cancro (EORTC) QLQ-C30, questionario sui sintomi del mieloma multiplo e sull'impatto (MySIm-Q), questionario EuroQol sulle cinque dimensioni (EQ-5D-5L), Impressione globale della gravità del paziente (PGIS) e versione dei risultati riportati dal paziente dei criteri comuni di terminologia per gli eventi avversi (PRO-CTCAE).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Followed until the end of the study (approximately up to 6 years)
    Seguito fino alla fine dello studio (circa fino a 6 anni)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    E.8.1.1. Randomizzato: SI - E.8.1.2. In aperto: SI
    E.8.1.1. Randomized: YES - E.8.1.2. Open-label: YES
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Australia
    Israel
    Japan
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    United Kingdom
    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
    The end of study is when approximately 250 deaths have occurred in the study.
    La fine dello studio è quando nello studio si saranno verificati circa 250 decessi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    E.8.9.2In all countries concerned by the trial months2
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 236
    F.4.2.2In the whole clinical trial 400
    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)
    After the end of the study, the sponsor will continue to monitor subjects treated with JNJ-68284528 for up to 15 years after administration of JNJ-68284528 on a separate long-term follow-up study for complications of lentiviral integration, potential delayed adverse events, including SPMs.
    Dopo la fine dello studio, lo sponsor continuerà a monitorare soggetti trattati con JNJ-68284528 per un massimo di 15 anni dopo la somministrazione di JNJ-68284528 con un separato studio di follow-up a lungo termine per complicanze dell'integrazione lentivirale, potenziali eventi avversi ritardati, inclusi SPM.
    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 Decision2020-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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