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    Summary
    EudraCT Number:2018-002761-19
    Sponsor's Protocol Code Number:OP201
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-08-01
    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 ConcernedNorway - NOMA
    A.2EudraCT number2018-002761-19
    A.3Full title of the trial
    An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    It is an early clinical trial to assess a new drug (Melflufen) when given
    together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis
    Patients should also have received treatment in the past for the disease.
    A.4.1Sponsor's protocol code numberOP201
    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 SponsorOncopeptides AB
    B.1.3.4CountrySweden
    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 supportOncopeptides AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncopeptides AB
    B.5.2Functional name of contact pointClinical Trials Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressVästra Trädgårdsgatan 15
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post codeSE-111 53
    B.5.3.4CountrySweden
    B.5.6E-mailtrials@oncopeptides.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMelflufen
    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 INNmelphalan fulfenamide hydrochloride
    D.3.9.1CAS number 380449-54-7
    D.3.9.3Other descriptive nameMELFLUFEN
    D.3.9.4EV Substance CodeSUB22033
    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: 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 Dexamethasone 4 mg JENAPHARM
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 H02AB02
    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/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    Patients with AL Amyloidosis
    E.1.1.1Medical condition in easily understood language
    Patients with AL Amyloidosis
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002022
    E.1.2Term Amyloidosis
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1
    •To explore the safety and tolerability
    •To identify recommended Phase 2 dose (RP2D).
    Phase 2
    •To evaluate the hematologic ORR after 4 cycles at the RP2D determined in Phase 1
    E.2.2Secondary objectives of the trial
    Phase 1
    •To assess pharmacokinetic profile of melflufen in this patient population
    •To assess best hematologic response
    •To assess duration of hematologic response
    •To assess the proportion of organ system responses
    •To assess duration of organ system responses
    •To assess hematologic ORR
    •To assess time to next AL amyloidosis treatment
    •To assess OS

    Phase 2

    •To assess safety and tolerability
    •To assess best hematologic response
    •To assess duration of hematologic response
    •To assess the proportion of organ system responses
    •To assess duration of organ system responses
    •To assess time to next AL amyloidosis treatment
    •To assess OS

    Exploratory

    •To assess MRD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 18 years or older at the time of signing the informed consent.
    2. Proven histochemical diagnosis of AL amyloidosis based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence confirmed with appropriate method of typing, e.g. mass spectrometry, immunofluorescence or immunohistochemistry (previous aspirate/biopsy tissue specimen result acceptable).
    3. At least one prior line of therapy, defined as either one non-transplant regimen, one ASCT, or one regimen of induction therapy followed by a single ASCT (without hematologic progression between induction and ASCT). No more than 4 cycles of melphalan containing chemotherapy is allowed.
    4. Measurable hematologic disease as defined by serum differential free light chain (dFLC) concentration ≥ 20 mg/L (dFLC is the difference between amyloid forming [involved] and non-amyloid forming [uninvolved] FLC).
    5. Objectively measurable (cardiac, and/or renal and/or liver) organ amyloid involvement, as defined below (amyloid involvement of at least 1 required). See also Appendix 9:
    a. Cardiac involvement: mean wall thickness >12 mm on echocardiogram, with no other cardiac cause or an elevated NT-ProBNP (>332 ng/L) in the absence of renal failure or atrial fibrillation.
    b. Renal involvement is defined as proteinuria (predominantly albumin) >0.5 g/day in a 24-hour urine collection.
    c. Hepatic involvement: Total liver span >15 cm in the absence of heart failure, or alkaline phosphatase >1.5 times institutional upper limit of normal (ULN).
    Amyloid involvement of other organ systems is allowed, but not required.
    6. ECOG performance status ≤ 2. See Appendix 5.
    7. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (See Appendix 4).
    8. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
    9. Less than 30% plasma cells in bone marrow aspirate or biopsy.
    10. 12-lead screening safety ECG with PR < 220 msec and QTcF interval of ≤ 470 msec calculated by Fridericia Formula (Appendix 12).
    11. Echocardiogram (ECHO) with left ventricular ejection fraction (LVEF) ≥ 45% in patients with known cardiac amyloidosis involvement.
    12. The following laboratory results must be met:
    • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 (1.5 x 109/L) (Growth factors cannot be used within 10 days (14 days for pegfilgrastim) prior to initiation of therapy)
    • Platelet count ≥ 100,000 cells/mm3 (100 x 109/L) without required transfusions during the 10 days prior to initiation of therapy).
    • Hemoglobin ≥ 9.0 g/dl (RBC transfusions are permitted).
    • Total Bilirubin ≤ 1.5 x ULN. Higher value may be accepted in participants diagnosed with Gilbert syndrome, if approved by the medical monitor.
    • AST and ALT ≤ 1.5 x ULN.
    • Renal function: Estimated GFR (eGFR) by CKD-EPI formula ≥ 45 mL/min (Appendix 11).
    13. Male participant agrees to use contraception as detailed in Appendix 4 of this protocol during the treatment period and for at least 90 days after the last dose of melflufen and refrain from donating sperm during this period.
    OR
    Female participant meets one of the following conditions:
    i. Not of child bearing potential as defined in Appendix 4
    ii. Not currently pregnant or breastfeeding and agrees to follow the contraceptive guidance in Appendix 4 during the treatment period and for at least 30 days after the last dose of melflufen.
    E.4Principal exclusion criteria
    1.Amyloidosis due to known mutations of the transthyretin gene or presence of another non-AL amyloidosis.
    2.Cardiac risk stage 3 with NT-pro-BNP >5000 pg/mL (Appendix 7).
    3.Evidence of gastro-intestinal bleeding
    •Frank bleeding within 6 months prior to initiation of therapy.
    •Positive feces-hemoglobin/ fecal occult blood test within 6 months prior to initiation of therapy if clinically relevant. In case of a positive test within the last 6 months, a colonoscopy and upper endoscopy are required to exclude clinically relevant conditions. Should the first examination provide a satisfactory explanation to the GI-bleed, the second examination might be cancelled at the discretion of the investigator.
    4.Evidence of mucosal or internal bleeding and/or are platelet transfusion refractory (i.e. platelet count fails to increase by ≥10,000 cells/mm3 [10 x 109/L] after transfusion of an appropriate dose of platelets).
    5.Medically documented cardiac syncope, NYHA Class 3 or 4 congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant ventricular arrhythmias, or atrioventricular (AV) block
    6.Clinically significant finding on 24 h Holter recording performed at screening, including but not limited to high degree AV block (2nd degree type 2 or 3rd degree AV block), ventricular arrythmias and sign of sick sinus syndrome. (Bundle branch block is acceptable if clinically stable for ≥6 months)
    7.Supine systolic blood pressure <90 mm Hg, or orthostatic hypotension defined as a decrease in systolic blood pressure upon standing of >20 mmHg or symptomatic orthostatic hypotension regardless of the amount of the drop in mmHg, despite medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion. See Section 8.3.2 for details on the assessment of orthostatic hypotension)
    8.Clinically significant factor X deficiency
    9.Clinically important autonomic disease
    10.Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study.
    11.Known active infection that is uncontrolled (including symptomatic or asymptomatic COVID-19) or has required intravenous systemic therapy or has required oral anti-infective treatment within 14 days of initiation of treatment; Other wash out period may be considered after consultation and approval of the medical monitor.
    12.Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, and very-low and low risk prostate cancer in active surveillance as defined in NCCN Guideline: Prostate Cancer (NCCN 2019).
    13.Pregnant or breast-feeding females.
    14.Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation.
    15.Known HIV or active hepatitis C viral infection.
    16.Known active hepatitis B viral infection (defined as HBsAg+)
    •Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-, Anti-HBs+, Anti-HBc-).
    •Non-active hepatitis B (HBsAg-, Anti-HBs+, Anti-HBc+) may be enrolled at the discretion of the investigator after consideration of risk of reactivation
    17.Concurrent symptomatic multiple myeloma (symptomatic defined as presence of bone lesion, extramedullary plasmacytoma or hypercalcemia)
    18.POEMS syndrome [plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes].
    19.Any of the following treatments, within the specified timeframe:
    •Previous cytotoxic therapies, including cytotoxic investigational agents, within 3 weeks (6 weeks for nitrosoureas) prior to initiation of therapy.
    •The use of live vaccines within 30 days before initiation of therapy.
    •Monoclonal antibodies within 4 weeks of initiation of therapy.
    •Prednisone up to but no more than 10 mg orally q.d. or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to initiation of therapy
    •Concomitant immunotherapy, investigational therapy and anticoagulation therapy are not permitted (low dose i.e. ≤ 150 mg OD acetylsalicylic acid permitted)
    20.Residual side effects to previous therapy > Grade 1 prior to initiation of therapy (Alopecia, or neuropathy Grade 2, are permitted).
    21.Prior autologous or allogeneic stem cell transplant within 12 weeks of initiation of therapy.
    22.Prior allogeneic stem cell transplant with active graft-versus-hostdisease (GVHD).
    23.Prior major surgical procedure or radiation therapy within 4 weeks of the first dose of study treatment.
    24.Known intolerance to steroid therapy, known hypersensitivity to melphalan or melflufen, or known hypersensitivity to any of the excipients of melflufen or the dexamethasone product
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    • Frequency and grade of adverse events (AE) and laboratory values
    • Dose-Limiting Toxicity (DLT) during Cycle 1 up to a maximum dose of melflufen of 40 mg
    Phase 2
    • The proportion of participants who achieve a hematologic Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the course of the study
    E.5.2Secondary end point(s)
    Phase 1
    • Melphalan plasma concentration post melflufen administration
    • Best hematologic response (CR, VGPR, PR, NR, or PD)
    • Duration of hematologic response (CR, VGPR, PR)
    • Proportion of participants with kidney, cardiac or liver response, respectively
    • Duration of organ system specific responses (separately for kidney, cardiac, and liver)
    • The proportion of participants who achieve a hematologic CR, VGPR, or PR
    • Time to next AL amyloidosis treatment
    • OS
    Phase 2
    • Frequency and grade of AEs and laboratory values
    • Best hematologic response (CR, VGPR, PR, NR, or PD)
    • Duration of hematologic response (CR, VGPR, PR)
    • Proportion of participants with kidney, cardiac or liver response, respectively
    • Duration of organ system specific responses (separately for kidney, cardiac, and liver)
    • Time to next AL amyloidosis treatment
    • OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the course of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Czechia
    France
    Germany
    Greece
    Israel
    Italy
    Norway
    Poland
    Spain
    United Kingdom
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 46
    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)
    Standard of Care.
    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 Decision2019-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-26
    P. End of Trial
    P.End of Trial StatusOngoing
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