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    Summary
    EudraCT Number:2015-002380-42
    Sponsor's Protocol Code Number:CRdvsR
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-002380-42
    A.3Full title of the trial
    Phase 3 Randomized trial of carfilzomib, lenalidomide, dexamethasone
    versus lenalidomide alone after stem-cell transplant for multiple myeloma.
    Randomizowane badanie kliniczne fazy 3, porównujące zastosowanie
    karfilzomibu w skojarzeniu z lenalidomidem i deksametazonem w stosunku
    do monoterapii lenalidomidomidem u pacjentów ze szpiczakiem
    plazmocytowym po przeszczepie komórek macierzystych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine whether a combination of 3 drugs called
    lenalidomide, carfilzomib and dexamethasone given to persons after
    autologous stem cell (a young cell without a specific purpose from which
    other cell types develop) transplant is better than lenalidomide
    maintenance alone.
    Badanie Kliniczne prowadzone celem ustalenia czy kombinacja trzech
    leków o nazwie lenalidomid, carfilzomib i dexametazon podana osobom po
    autologicznej transplantacji komórek macierzystych (pierwotne,
    niewyspecjalizowane komórki nie posiadające określonego przeznaczenia,
    które mają zdolność do przekształcania się w wyspecjalizowane komórki)
    jest skuteczniejsza niż podawanie samego leku lenalidomid.
    A.4.1Sponsor's protocol code numberCRdvsR
    A.5.4Other Identifiers
    Name:Polish Myeloma Consortium Study NumberNumber:PMC006
    Name:IRB NumberNumber:IRB15-1286
    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 SponsorPolish Myeloma Consortium
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity of Chicago
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCelgene Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPolish Myeloma Consortium
    B.5.2Functional name of contact pointPolish Myeloma Consortium
    B.5.3 Address:
    B.5.3.1Street AddressSzamarzewskiego 84
    B.5.3.2Town/ cityPoznan
    B.5.3.3Post code60-569
    B.5.3.4CountryPoland
    B.5.4Telephone number+48618549571
    B.5.5Fax number+48618549356
    B.5.6E-mailinfo@pmc.edu.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Yes
    D.2.1.1.1Trade name Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 7
    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 Kyprolis
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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/3/08/548
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution 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.3.8INN - Proposed INNCarfilzomib
    D.3.9.1CAS number 868540-17-4
    D.3.9.3Other descriptive nameCARFILZOMIB
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 8
    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.2.1.2Country which granted the Marketing AuthorisationPoland
    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.3.4Pharmaceutical 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 INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    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 number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Myeloma
    Szpiczak Mnogi
    E.1.1.1Medical condition in easily understood language
    Cancer of plasma cells, a type of white blood cell normally responsible for producing antibodies.
    Nowotwór, który powstaje z komórek plazmatycznych (produkujących przeciwciała).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare progression free survival (PFS) between KRd (Kyprolis, Revlimid, Dexamethasone) and lenalidomide (Revlimid) arm after randomization.
    Porównanie czasu przeżycia bez progresji choroby (PFS) u pacjentów poddanych terapii KRd (Kyprolis, Revlimid, Dexamethasone) w porównaniu z pacjentami leczonymi wyłącznie lenalidomidem (Revlimid).
    E.2.2Secondary objectives of the trial
    To determine the rate of MRD-negative disease at 6, 12, 18, 24, and 36 months after randomization
    To compare the efficacy (rate of PR, VGPR, CR, and sCR) of KRd vs. Lenalidomide alone after randomization
    To evaluate the safety and tolerability of KRd compared to lenalidomide alone
    Oszacowanie szybkości negatywizacji wyniku minimalnej choroby resztkowej w 6, 12, 18, 24, 36 miesiącu po randomizacji.
    Porównanie skuteczności (odsetek PR, VGPR, CR i sCR) terapii KRd w porównaniu z monoterapią lenalidomidem.
    Ocena bezpieczeństwa i tolerancji terapii KRd w porównaniu z monoterapią lenalidomidem.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Patients who completed single autologous stem cell transplant after completion of at most 2 induction regimens (excluding dexamethasone alone) and are in at least stable disease prior to randomization in the first 100 days after stem cell transplantation.
    2)Patient must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens
    3)Bone marrow specimen will be required at study entry; available DNA sample from pre-induction BM will be used for calibration step for MRD evaluation by gene sequencing.
    4)Males and females ≥18 years of age
    5)ECOG performance status of 0-1
    6)Adequate hepatic function, with bilirubin ≤1.5 x ULN and aspirate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 xULN
    7)ANC ≥1.0 x 109/L, hemoglobin ≥8 g/dL, platelet count ≥75 x 109/L.
    8)Calculated creatinine clearance (by Cockroft-Gault) ≥50 ml/min or serum creatinine below 2 g/dL
    9)Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for Cycle 1 (prescriptions must be filled within 7 days).
    10)FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
    11)Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
    12)All study participants must be consented to and registered into the mandatory RevlimidREMS® program and be willing and able to comply with the requirements of RevlimidREMS®.
    13)Voluntary written informed consent
    1)Pacjenci z zakończoną procedurą przeszczepu autologicznego komórek macierzystych którzy otrzymali najwyżej dwie linie leczenia indukcyjnego (wyłączając sam deksametazon) i znajdują się przynajmniej w stabilnym stadium choroby w ciągu 100 pierwszych dni po przeszczepie autologicznym komórek macierzystych.
    2)Pacjenci w ciągu 12 miesięcy od inicjacji leczenia indukcyjnego, którzy otrzymali nie więcej niż dwie linie leczenia indukcyjnego.
    3)Na wejściu do badania będzie wymagana próbka szpiku kostnego; dostępne próbki DNA ze szpiku kostnego sprzed terapii indukcyjnej będą stanowić próbkę wzorcową do oceny MRD metodą sekwencjonowania genów.
    4)Mężczyźni lub kobiety w wieku ≥ 18 lat.
    5)Stopień sprawności 0-1 w skali ECOG.
    6)Prawidłowa funkcja wątroby:
    ▪ bilirubina ≤ 1,5 x ULN
    ▪ AST (aminotransferaza asparaginowa) ≤ 3 x ULN
    ▪ ALT (aminotransferaza alaninowa) ≤ 3 x ULN.
    7)ANC ≥ 1.0 x 109/L, hemoglobina ≥ 8 g/dL, liczba płytek krwi ≥ 75 x 109/L.
    8)Klirens kreatyniny (obliczony według wzoru Cockcroft-Gault’a) ≥ 50 ml/min lub stężenie kreatyniny w surowicy poniżej 2 mg/dL.
    9)W przypadku kobiet w wieku rozrodczym (FCBP), negatywny wynik dwóch testów ciążowych (czułość przynajmniej 50 mIU/mL) przed rozpoczęciem terapii lenalidomidem. Pierwszy test ciążowy musi być wykonany w ciągu 10-14 dni przed, a drugi test w ciągu 24 godzin przed wydaniem lenalidomidu na Cykl 1.
    10)Kobiety w wieku rozrodczym muszą wyrazić zgodę na stosowanie 2 wiarygodnych metod antykoncepcji jednocześnie lub utrzymanie pełnej wstrzemięźliwości w stosunkach heteroseksualnych w następujących okresach czasu związanych z badaniem: 1) przez przynajmniej 28 dni przed rozpoczęciem leczenia lenalidomidem, 2) podczas udziału w badaniu, 3) przez przynajmniej 28 dni po zakończeniu udziału w badaniu.
    11)Mężczyźni muszą zgodzić się na stosowanie lateksowych prezerwatyw podczas kontaktów seksualnych z kobietami w wieku rozrodczym podczas udziału w badaniu oraz przez przynajmniej 28 dni po zakończeniu udziału w badaniu, nawet po udanym zabiegu wazektomii.
    12)Dobrowolna, pisemna zgoda pacjenta na udział w badaniu.
    E.4Principal exclusion criteria
    1)Patients who have had more than 12 months of prior therapy. Patients outside of this window may be considered for inclusion. Please contact the Sponsor’s representative in Poland or the Lead Primary Investigator as appropriate on a case-by-case basis
    2)Patients who progressed after initial therapy.
    a)Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression.
    b)No more than two regimens for induction will be allowed, excluding dexamethasone alone.
    3)Potential subjects with evidence of progressive disease as per IMWG criteria
    4)Patients who have already started or received post-transplant maintenance or consolidation regimen
    5)Patients not able to tolerate lenalidomide or carfilzomib or dexamethasone
    6)POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
    7)Plasma cell leukemia
    8)Waldenström’s macroglobulinemia or IgM myeloma
    9)Peripheral neuropathy ≥ Grade 2 at screening
    10)Diarrhea > Grade 1 in the absence of antidiarrheals
    11)CNS involvement
    12)Pregnant or lactating females
    13)Radiotherapy within 14 days before randomization. Seven days may be considered if to single area
    14)Major surgery within 3 weeks prior to first dose
    15)Myocardial infarction within 3 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    16)Prior or concurrent deep vein thrombosis or pulmonary embolism
    17)Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening
    18)Uncontrolled hypertension or diabetes
    19)Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
    20)Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
    21)Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
    22)Any clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
    1)Pacjenci, którzy otrzymywali poprzednią terapię dłużej niż 12 miesięcy.
    2)Pacjenci, u których stwierdzono progresję choroby po leczeniu początkowym.
    a) Pacjenci, których terapia została zmodyfikowana z powodu odpowiedzi na leczenie poniżej optymalnego poziomu, nietolerancji itp., kwalifikują się do badania, pod warunkiem, że nie spełniają kryteriów progresji.
    b) Dopuszcza się nie więcej niż dwie linie terapii indukcyjnej, wyłączając leczenie samym deksametazonem.
    3)Pacjenci spełniający kryteria progresji choroby według kryteriów IMWG.
    4)Pacjenci, którzy właśnie rozpoczęli lub otrzymali terapię podtrzymującą po transplantacji lub leczenie konsolidacyjne.
    5)Pacjenci nietolerujący leczenia lenalidomidem, carfilzomibem lub deksametazonem.
    6)Zespół POEMS (polineuropatia, organomegalia, endokrynopatia, monoklonalna gammapatia, zmiany skórne).
    7)Białaczka plazmocytowa.
    8)Makroglobulinemia Waldenströma lub szpiczak mnogi IgM.
    9)Neuropatia obwodowa ≥ stopnia 2 podczas wizyty przesiewowej.
    10)Biegunka > 1 stopnia bez stosowania leków przeciwbiegunkowych.
    11)Zajęcie centralnego układu nerwowego.
    12)Kobiety w ciąży lub karmiące piersią.
    13)Radioterapia w ciągu 14 dni przed randomizacją. Można rozważyć przypadek radioterapii na 7 dni przed randomizacją, jeżeli była ograniczona do jednego obszaru.
    14)Poważna operacja na 3 tygodnie przed pierwszą dawką leczenia.
    15)Zawał serca przebyty w ciągu 6 miesięcy przed włączeniem pacjenta do badania, klasa III lub IV niewydolności serca w skali NYHA, niekontrolowana dusznica, poważne, niekontrolowane arytmie komorowe lub elektrokardiograficzne dowody ostrego niedokrwienia lub aktywne zaburzenia układu przewodzącego.
    16)Zakrzepica żył głębokich lub zatorowość płucna wcześniej lub obecnie.
    17)Skorygowany odstęp QT (QTc) > 470 msec. w 12-odprowadzeniowym EKG na wizycie przesiewowej.
    18)Niekontrolowane nadciśnienie tętnicze lub cukrzyca.
    19)Ostra infekcja wymagająca stosowania antybiotyków, leków przeciwwirusowych, lub przeciwgrzybiczych w ciągu dwóch tygodni przed przyjęciem pierwszej dawki.
    20)Stwierdzone aktywne zakażenie ludzkim wirusem niedoboru odporności (HIV), wirusem zapalenia wątroby typu B (HBV) lub wirusem zapalenia wątroby typu C (HCV). Pacjenci, u których seropozytywność jest wynikiem szczepienia przeciwko HBV mogą zostać włączeni do badania.
    21)Niehematologiczne nowotwory złośliwe lub niemnogie złośliwe nowotwory hematologiczne w ciągu ostatnich 3 lat; z wyjątkiem:
    a)odpowiednio leczonego nowotworu podstawnokomórkowego skóry, płaskonabłonkowego skóry,
    b)raka tarczycy,
    c)raka szyjki macicy in situ,
    d)raka prostaty < 6 punktów w skali Gleasona, ze stabilnym poziomem antygenu gruczołu krokowego lub uważanego za wyleczony w wyniku resekcji.
    22)Wszystkie istotne z punktu klinicznego choroby lub stany pacjenta, które zdaniem badacza mogą zakłócać postępowanie zgodne z protokołem lub zdolność pacjenta do wyrażenia świadomej zgody.
    E.5 End points
    E.5.1Primary end point(s)
    The comparison of PFS rates between patients treated with KRd vs. R alone after SCT will be achieved by measuring the time to progressive disease or death as defined by IMWG (International Myeloma Working Group) criteria.
    Porównanie czasu przeżycia bez progresji choroby (PFS) u pacjentów poddanych terapii KRd (Kyprolis, revlimid, Dexamethasone) w porównaniu z pacjentami leczonymi wyłącznie lenalidomidem (Revlimid) po przeszczepie komórek macierzysztych, definiowanego jako czas do wystąpienia progresji choroby według kryteriów IMWG (International Myeloma Working Group) lub śmierci.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to progression or death will be calculated from the date of first treatment until progression assessed by the Investigator according to IMWG (International Myeloma Working Group) criteria or death.
    Czas do wystąpienia progresji choroby lub śmierci jest definiowany jako czas od podania pierwszej dawki leczenia do czasu wystąpienia progresji choroby oszacowanego przez Badacza zgodnie z kryteriami IMWG (Międzynarodowa Grupa Robocza ds. Szpiczaka Mnogiego) lub śmierci.
    E.5.2Secondary end point(s)
    Determine the correlation between the MRD status at 6, 12, 18, 24, and 36 months and median PFS in both arms.
    Determine rates of improvement of the depth of response by at least one category according to IMWG response criteria. (For example, an improvement from very good partial response (VGPR) to near complete response (nCR) or better than nCR including conversion from CR to MRD negative disease [overall response]) at 6 and 12 months.
    Compare overall survival between arms.
    Determine the duration of MRD-negative disease.
    Safety and tolerability of experimental arm vs. control.
    Określenie zależności pomiędzy statusem MRD na ukończeniu cyklu 6,12,18,24 i 36 a medianą PFS czasu wolnego od progresji choroby w obu ramionach badania.
    Oszacowanie odsetka poprawy głębokości odpowiedzi klinicznej o co najmniej jedną kategorię zgodnie z kryteriami odpowiedzi IMWG. Na przykład: poprawa z bardzo dobrej remisji częściowej (VGPR) do prawie całkowitej remisji (nCR) lub lepiej niż nCR włączając konwersję z całkowitej remisji (CR) do negatywizacji MRD [całkowita odpowiedź] w 6 i 12 miesiącu.
    Porównanie czasu całkowitego przeżycia pomiędzy obydwoma ramionami badania.
    Oszacowanie czasu trwania negatywizacji wyniku minimalnej choroby resztkowej.
    Porównanie bezpieczeństwa i tolerancji terapii stosowanej w ramieniu kontrolnym i eksperymentalnym.
    E.5.2.1Timepoint(s) of evaluation of this end point
    MRD evaluation at 6, 12, 18, 24, and 36 months.
    Determine the depth of disease response at 6 and 12 months.
    Overall Survival defined as time from first study treatment dose to death due to any cause.
    Ocena minimalnej choroby resztkowej w 6, 12, 18, 24 i 36 miesiącu leczenia.
    Oszacowanie głębokości odpowiedzi klinicznej 2 6 i 12 miesiącu leczenia.
    Czas całkowitego przeżycia definiowany jako czas od podania pierwszej dawki leczenia do śmierci.
    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 Yes
    E.6.10Pharmacogenetic Yes
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LVLS
    Ostatnia wizyta ostatniego pacjenta w badaniu.
    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 months6
    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 months6
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Brak
    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 Decision2016-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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