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    Summary
    EudraCT Number:2020-004972-17
    Sponsor's Protocol Code Number:AGMT_MM-4
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-04-26
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-004972-17
    A.3Full title of the trial
    Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)
    Isatuximab in Kombination mit Lenalidomid-Dexamethason im Vergleich zu Lenalidomid-Dexamethason bei älteren Patienten (≥70 Jahre) mit neu diagnostiziertem multiplem Myelom: eine randomisierte Phase II Studie (SGZ-2019-12650). (AGMT_MM-4)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged ≥70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)
    Isatuximab in Kombination mit Lenalidomid-Dexamethason im Vergleich zu Lenalidomid-Dexamethason bei älteren Patienten (≥70 Jahre) mit neu diagnostiziertem multiplem Myelom: eine randomisierte Phase II Studie (SGZ-2019-12650). (AGMT_MM-4)
    A.3.2Name or abbreviated title of the trial where available
    AGMT_MM-4
    A.4.1Sponsor's protocol code numberAGMT_MM-4
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04891809
    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 SponsorAGMT gGmbH
    B.1.3.4CountryAustria
    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 supportSanofi-aventis GmbH Österreich
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAGMT gGmbH
    B.5.2Functional name of contact pointClinical Trial Lead Manager
    B.5.3 Address:
    B.5.3.1Street AddressWolfsgartenweg 31
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number+436626404411
    B.5.5Fax number+436626404414
    B.5.6E-maild.wolkersdorfer@agmt.at
    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 SARCLISA
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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.3.4Pharmaceutical form Concentrate 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 INNIsatuximab
    D.3.9.1CAS number 1461640-62
    D.3.9.4EV Substance CodeSUB187359
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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
    Newly diagnosed, symptomatic multiple myeloma in elderly patients
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed, symptomatic multiple myeloma in elderly patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10028229
    E.1.2Term Multiple myelomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the benefit of isatuximab in combination with lenalidomide and low-dose dexamethasone followed by isatuximab and lenalidomide maintenance therapy in increasing the proportion of patients with MRD negativity as compared to lenalidomide and low-dose dexamethasone followed by lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM).
    E.2.2Secondary objectives of the trial
    1) To evaluate the Overall Response Rate (ORR), Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) as per International Myeloma Working Group (IMWG) criteria in each arm.
    2) To compare the Progression-free (PFS) and Overall Survival (OS) between the two arms.
    3) To evaluate the proportion of patients with MRD negativity (defined by NGF at 10^-5) after 12 months (13 cycles) of maintenance treatment.
    4)To evaluate the Time to Progression (TTP) in each arm.
    5) To evaluate the PFS in high risk cytogenetic population defined as patients carrying a) del(17p), t(4;14), t(14;16) in each arm and b) the same aberrations plus amp1q21.
    6) To evaluate the Duration of Response in each arm.
    7) To evaluate safety in both treatment arms.
    8) To assess disease-specific and a generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility and health status.
    9) To evaluate PFS of potential second line therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 70 years
    • Able to provide written informed consent in accordance with federal, local, and institutional guidelines
    • Patients must have newly diagnosed, symptomatic multiple myeloma with evidence of measurable disease (assessed within 21 days prior to randomization)
    o Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis
    and/or
    o Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis
    and/or
    o In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) ≥100 mg/L (involved light chain) and an abnormal FLC ratio
    • No prior treatment for multiple myeloma
    • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
    • Patients at cardiac risk (NYHA >ll) or pre-existing coronary heart disease, or any other clinically relevant cardiac complication) should be scheduled for a baseline ECHO and can only be included if the LVEF is >40%
    • Adequate organ and bone marrow function within the 21 days prior to randomization defined by:
    o Bilirubin < 2 times the upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN
    o Absolute neutrophil count (ANC) ≥ 750/mm3 (growth factor support for max 3 days allowed to achieve this value)
    o Hemoglobin >8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.)
    o Platelet count >50,000/mm3
    o Calculated or measured creatinine clearance (CrCl) of ≥30 mL/min (Calculation should be based on the MDRD formula (age, gender, black/non- black, weight, height)
    E.4Principal exclusion criteria
    • ECOG status >2
    • Patients unlikely to tolerate Rd
    • Waldenström macroglobulinemia
    • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
    • Plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differential)
    • Myelodysplastic syndrome
    • Smoldering Myeloma and MGUS
    • Second malignancy within the past 5 years except:
    o Adequately treated basal cell or squamous cell skin cancer
    o Carcinoma in situ of the cervix
    o Prostate cancer ≤ Gleason score 6 with stable prostate-specific antigen (PSA over 12 months)
    o Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
    o Treated medullary or papillary thyroid cancer
    o Other tumors with low risk of recurrence/metastases and/or early stage R0 surgery
    • History of or current amyloidosis
    • Glucocorticoid therapy within the 14 days prior to randomization that exceeds an accumulated dose of 160 mg dexamethasone or 1000 mg prednisone
    • Extended field radio therapy (more than 3 fields) within the 21 days prior to randomization
    • Contraindication to isatuximab, dexamethasone, lenalidomide or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
    • Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 4 months prior to enrolment
    • Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy
    • Uncontrolled hypertension or uncontrolled diabetes despite medication
    • Significant neuropathy (Grade 2 with pain or Grade 3 or higher) within the 14 days prior to randomization
    • Known cirrhosis
    • Known human immunodeficiency virus (HIV) seropositivity or active hepatitis C or hepatitis B infection (subjects with past hepatitis B virus [HBV] infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test are eligible; subjects positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV RNA.)
    • Participation in another interventional study within the 28 days prior to randomization
    • Major surgery (except kyphoplasty) within the 28 days prior to randomization
    • Any other clinically significant medical disease or social condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent, be compliant with study procedures, or provide accurate information.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the proportion of patients with MRD negativity (defined by NGF (next generation flow) at 10^-5) after end of induction treatment in the two arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of induction treatment (8 cycles á 28 days).
    E.5.2Secondary end point(s)
    1) To evaluate the Overall Response Rate (ORR), Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) as per International Myeloma Working Group (IMWG) criteria in each arm.
    2) To compare the Progression-free (PFS) and Overall Survival (OS) between the two arms.
    3) To evaluate the proportion of patients with MRD negativity (defined by NGF at 10^-5) after 12 months (13 cycles) of maintenance treatment.
    4)To evaluate the Time to Progression (TTP) in each arm.
    5) To evaluate the PFS in high risk cytogenetic population defined as patients carrying a) del(17p), t(4;14), t(14;16) in each arm and b) the same aberrations plus amp1q21.
    6) To evaluate the Duration of Response in each arm.
    7) To evaluate safety in both treatment arms.
    8) To assess disease-specific and a generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility and health status.
    9) To evaluate PFS of potential second line therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For secondary endpoints 1-8: after a maximum of 32 treatment cycles (8 cycles of induction therapy (á 28 days) and 24 cycles (á 28 days) of maintenance treatment)
    For secondary endpoint 9: after end of treatment according to protocol (32 treatment cycles), progression or intolerability
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Serbia
    Austria
    Greece
    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
    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 days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 198
    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 No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 198
    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.
    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 Decision2021-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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