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    Summary
    EudraCT Number:2020-004742-11
    Sponsor's Protocol Code Number:64007957MMY3001
    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:2021-11-29
    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 number2020-004742-11
    A.3Full title of the trial
    A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC (Tec-Dara) versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants with Relapsed or Refractory Multiple Myeloma
    Studio randomizzato di fase 3 per confrontare teclistamab in combinazione con daratumumab SC (Tec-Dara) rispetto a daratumumab SC, pomalidomide e desametasone (DPd) o daratumumab SC, bortezomib e desametasone (DVd) in pazienti con mieloma multiplo recidivante o refrattario (MajesTEC-3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized phase 3 study of Teclistamab in combination with daratumumab verses an Investigators choice of Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Velcade, Dexamethasone in Relapsed or Refractory Multiple Myeloma
    Uno studio randomizzato di fase 3 su Teclistamab in combinazione con daratumumab rispetto a una scelta dello sperimentatore di Daratumumab, Pomalidomide, Desametasone o Daratumumab, Velcade, Desametasone nel mieloma multiplo recidivante o refrattario
    A.3.2Name or abbreviated title of the trial where available
    MajesTEC-3
    MajesTEC-3
    A.4.1Sponsor's protocol code number64007957MMY3001
    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.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.5.3.4CountryBelgium
    B.5.4Telephone number0031715242106
    B.5.5Fax number0031715242110
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2331
    D.3 Description of the IMP
    D.3.1Product nameTeclistamab
    D.3.2Product code [JNJ-64007957]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNTeclistamab
    D.3.9.2Current sponsor codeJNJ-64007957
    D.3.9.4EV Substance CodeSUB185866
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman IgG4 bispecific antibody against BCMA and CD3
    D.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2331
    D.3 Description of the IMP
    D.3.1Product nameTeclistamab
    D.3.2Product code [JNJ-64007957]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNTeclistamab
    D.3.9.2Current sponsor codeJNJ-64007957
    D.3.9.4EV Substance CodeSUB185866
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman IgG4 bispecific antibody against BCMA and CD3
    D.IMP: 3
    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 Darzalex
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab co-formulato con ialuronidasi ricombinante umana (rHuPH20)
    D.3.2Product code [JNJ-54767414]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.9.3Other descriptive nameHUMAX-CD38
    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: 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 Neofordex
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires CTRS
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.2Current sponsor codedexamethasone
    D.3.9.3Other descriptive namedexamethasone
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 4
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product nameImnovid
    D.3.2Product code [Imnovid]
    D.3.4Pharmaceutical form Capsule
    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 INNImnovid
    D.3.9.1CAS number 19171-19-8
    D.3.9.2Current sponsor codeImnovid
    D.3.9.3Other descriptive namePOMALIDOMIDE
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 4
    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 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 nameVelcade
    D.3.2Product code [Velcade]
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    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 codeN/A
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 3
    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
    Multiple Myeloma
    Mieloma Multiplo
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of Tec-Dara with DPd/DVd
    confrontare l'efficacia dell'associazione teclistamab/daratumumab con DPd/DVd
    E.2.2Secondary objectives of the trial
    - To further compare the efficacy of Tec-Dara with DPd/DVd
    - To assess the safety profile of Tec-Dara
    - To characterize the PK of teclistamab
    - To assess the immunogenicity of teclistamab and daratumumab
    - To compare the patient-reported outcomes (PROs) of Tec-Dara with DPd/DVd
    - To evaluate the efficacy of teclistamab in-high-risk molecular subgroups
    confrontare l'efficacia dell'associazione teclistamab/daratumumab con la terapia DPd/DVd
    valutato il profilo di sicurezza dell'associazione teclistamab daratumumab
    caratterizzare la PK di teclistamab
    valutare l'immunogenicità di teclistamab e di daratumumab
    confrontare i patient reported outcome (PRO) dell'associazione teclistamab/daratumumab e DPd/DVd
    valutare l'efficacia di teclistamab nei sottogruppi molecolari ad alto rischio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. =18 years of age.
    2. Documented multiple myeloma as defined by the criteria below:
    a. Multiple myeloma diagnosis according to the IMWG diagnostic criteria
    b. Measurable disease at screening as defined by any of the following:
    1) Serum M-protein level =0.5 g/dL (central laboratory); or
    2) Urine M-protein level =200 mg/24 hours (central laboratory); or
    3) Serum immunoglobulin free light chain =10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio.
    3. Received 1 to 3 prior line(s) of antimyeloma therapy (Appendix 6) including a PI and lenalidomide.
    a. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory (ie, have demonstrated progressive disease by IMWG criteria during treatment or within 60 days
    of completion of lenalidomide-containing regimen). Progression on orwithin 60 days of the last dose of lenalidomide given as maintenance will meet this criterion.
    4. Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen.
    5. Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment (Appendix 7).
    6. Have clinical laboratory values meeting the following criteria during the Screening Phase. In addition, these laboratory values must be reevaluated within the 72 hours prior to the first dose and the participant must also meet all criteria. If one or more criteria are not met 72 hours prior to dosing, one repeat of laboratory testing is permitted. If >1 repeat laboratory test is necessary, the sponsor must be consulted prior to dosing
    7. A woman of childbearing potential must have a negative highlysensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study
    8. A woman must be:
    a. Not of childbearing potential, or
    b. Of childbearing potential and
    1) Practicing true abstinence; or
    2) Have a sole partner who is vasectomized; or
    3) Practicing =2 methods of contraception (at least 1 highly effective). For participants who are of childbearing potential and treated with DPd in Arm B, see Section 6.12.3 for details regarding concomitant use of estrogen-containing products and pomalidomide.
    9. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study treatment
    10. A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.
    11. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.
    12. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol (Section 5.3)
    13. Must sign an ICF (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    1 maggiore età
    2mieloma multiplo così definito:
    a diagnosi secondo i criteri del IMWG
    b. malattia misurabile allo screening così definita: 1) proteina sierica M =0.5 g/dL o 2) proteina M secreta nellèurina =200 mg/24 hours o3) immunoglobulina libera sierca a catena leggera =10 mg/dL
    3 deve aver ricevuto da 1 a 3 linee di trattamento inclusa un PI e la lenalidomide
    4) progressione di patologia documentata in base ai criteri IMWG
    5) performance ECOG 0 1 o 2 allo screening e subito prima della somministrazione del farmaco di studio
    6) valori di laopratorio concordi con i seguenti criteri; in aggiunta, i test devono essere rieffettuati entro 72 ore prima della prima dose e i partecipanti devono rispettare tutti i criteri. se uno o più criteri non sono rspettati entro le 72 ore precedenti, si può rifare un test di laboratorio. se dev'essere ripetuto più di un test, lo sponsor dev'essere consultato prima cheil trattamento sia somministrato.
    7) una donna in età fertile deve avere un test di gravidanza su siero negativo, allo screening e entro 24 ore dall'inizio del trattamento di studio, e deve acconsentire a farne altri durante lo studio
    8) una donna deve essere in età non fertile o deve praticare astinenza, o avere un solo partner vasectomizzato, o utilizzare almeno 2 metodi metodi di contraccezione (di cui almeno 1 altamente efficaci)
    9) una donna non deve donare ovuli per la durata dello studio e nei 90 giorni successivi alla fine
    10) un'uomo deve utilizzare preservativi, durante il trattamento e fino a 90 giorni dopo
    11) un uomo non deve donare sperma per la durata dello studio e nei 90 giorni successivi alla fine
    12) deve volontariamente aderire allo stile di vita richiesto dallo studio
    13) deve firmare un consenso informato (o il rappresentante legale deve farlo per loro), indicando che lo scopo della ricerca viene compreso
    E.4Principal exclusion criteria
    1 Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab Investigator's Brochure and appropriate package inserts), Additional exclusion criteria pertaining to specific study drugs include:
    a. A participant is not eligible to receive DPd as control therapy if any of the following are present:
    1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide
    2) Disease that is considered refractory to pomalidomide per IMWG (progression during treatment or within 60 days of completing treatment with pomalidomide).
    b. A participant is not eligible to receive DVd as control therapy if any of the following are present:
    1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib (intolerance defined as prior therapy discontinued due to any AE related to bortezomib)
    2) Grade 1 peripheral neuropathy with pain or Grade =2 peripheral neuropathy as defined by NCI-CTCAE Version 5.0
    3) Disease that is considered refractory to bortezomib per IMWG
    4) Received a strong CYP3A4 inducer (see Section 6.12.3.3) within 5 half-lives prior to randomization.
    c. A participant is not eligible for this study if they are refractory to both pomalidomide and bortezomib.
    2. Received any prior BCMA-directed therapy.
    3. Has disease that is considered refractory to an anti-CD38 monoclonal antibody per IMWG (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody).
    4. Received the following prior antimyeloma therapy, in the specified time frame prior to randomization:
    a. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or =5 half-lives, whichever is less
    b. Investigational vaccine within 4 weeks
    c. Monoclonal antibody therapy within 21 days
    d. Cytotoxic therapy within 21 days
    e. PI therapy within 14 days
    f. IMiD agent therapy within 14 days
    g. Radiotherapy within 14 days or focal radiation within 7 days
    h. Gene-modified adoptive cell therapy within 3 months.
    5. Stem cell transplant:
    a. An allogeneic stem cell transplant within 6 months before randomization. in case, the pts must be off all immunosuppressive medications for =42 days without signs of graft-versus-host disease before randomization.
    b. An autologous stem cell transplant within 12 weeks before randomization.
    6. Received a cumulative dose of corticosteroids equivalent to =140 mg of prednisone within 14 days before randomization.
    7. Received a live, attenuated vaccine within 4 weeks before randomization.
    8. Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma. The only allowed exceptions are:
    a. Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured
    b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured
    c. Noninvasive cervical cancer treated within the last 24 months that is considered completely cured
    d. Localized prostate cancer (N0M0):
    1) With a Gleason score of =6, treated within the last 24 months, or untreated and under surveillance
    2) With a Gleason score of 3+4 that has been treated >6 months prior to full study screening and considered to have a very low risk of recurrence, or
    3) History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.
    e. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence
    f. Other malignancy that is considered cured with minimal risk of recurrence.
    9. Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
    1. controindicazioni quali allergie gravi, ipersensibilità o intolleranza ai farmaci o agli eccipienti;
    A) un paziente non è eleggibile per terapia con DPd se:
    1 esistono contronindicazioni quali allergie gravi, ipersensibilità o intolleranza;
    2 la malattia è refrattaria al trattamento con pomalidomide in base ai criteri IMWG
    B) un paziente non è eliggibile alla terapia con DVd se:
    1 esistono controindicazioni quali allergie gravi, ipersensibilità o intolleranza;
    2 c'è una neuropatia periferica di grado 1 con dolore o di grado 2 definita dai criteri NCI-CTCAE v5.0
    3 la malattia è refrattaria al Bortezomib seocndo i criteri IMWG
    4 ha ricevuto un forte induttore del CYP3A4 entro 5 emivite prima della randomizzazione
    C) un partecipante non è eleggibile per questo studio se sono refrattari sia al pomalidomide che al bortezomib

    2 ha ricevuto una terapia contro BCMA
    3 ha delle malattie che sono considerate refrattarie agli anticorpi monolconali anti CD38 in base ai crtieri IMWG
    4 ha ricevuto una qualsiasi precedente terapia antimieloma, in un periodo di tempo specifico prima della randomizzazione
    a: terapia target, terapia epigenetica, trattamento con farmaci sperimentali o con dispositivi medici sperimentali invasivi entro 21 gg o 5 emivite del farmaco
    b vaccini sperimentali entro 4 settimane
    c. terapia monoclonale entro 21 gg
    d terapia citotossica entro 21 gg
    e terapia PI entro 14 gg
    f terapia con agenti IMiDentro 14 gg
    g radioterapia entro 14 gg o radiazione focale entro 7 gg
    h cellule ingegnerizzate entro 3 mesi

    5.trapianto di cellule staminali:
    a trapianto di cellule allogeniche staminali entro 6 mesi; in caso, il paziente deve aver smesso le terapie immunospprressive entro 42 gg senza segni di patologie da innesto prima della randomizzazione
    b trapianto di cellule staminali autologhe entro 12 settimane prima della randomizzazione

    6 non deve aver rcevuto una dose comulativa di corticosteroidi fino a 140mg di prednisone entro 14gg
    7 non deve aver recrvuto un vaccino vivo attenuato entro 4 settimane
    8 non deve avere sindrome mielodisplastica o altri tumori maligni attivi, a meno che non sia un mieloma multiplo refrattario. le uniche eccezioni sono:
    a. tumore alla vescica non invasivo, entro 24 mesi e curato
    b. tumore alla pelle trattato entro 24 mesi e curato
    c tumore alla cervice uterina trattato entro 24 mesi e curato
    d. tumore alla prostata localizzato (N0M0):
    1 con punteggio Gleason =6, trattato da 24 mesi non trattato
    2 con punteggio Gleason 3o4, trattato entro 6 mesi prima dello screening e con rischio di recidiva molto basso
    3 storia di tumore alla prostata localizzato trattato con terapia androgeno deprivante
    e tumore al seno, tumore loculare trattato o duttale trattato; storia di tumore localizzato al senso trattato con agenti antiormonali
    f. altri tumori maligni

    9 leucemia delle plasmacellule, macroglobulinemia di Waldestrom, sindrome POEMS, amiloidosi a catena leggera primaria
    E.5 End points
    E.5.1Primary end point(s)
    PFS
    sopravvivenza senza progressione di patologie
    E.5.1.1Timepoint(s) of evaluation of this end point
    dosing day
    il giorno della somministrazione
    E.5.2Secondary end point(s)
    - Overall response (PR or better)
    - VGPR or better
    - CR or better
    - MRD negativity
    - PFS-2
    - OS
    - Time to next treatment
    risposta globale
    VGPR
    CR
    negatività MRD
    PFS-2
    OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    dosing day
    il giorno della somministrazione
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Argentina
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Russian Federation
    Taiwan
    Ukraine
    United States
    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
    Final OS analysis
    analisi finale della sopravvivenza globale
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 504
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 No
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 254
    F.4.2.2In the whole clinical trial 560
    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)
    nessuna
    nessuna
    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 Decision2022-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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