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    Summary
    EudraCT Number:2018-001715-79
    Sponsor's Protocol Code Number:BL-8040.SCM.301
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-25
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-001715-79
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects with Multiple Myeloma – The GENESIS Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and effect of BL-8040 with G-CSF on collection of blood stem cells for transplant in patients with multiple myeloma
    A.3.2Name or abbreviated title of the trial where available
    BL-8040 with G-CSF for Stem Cell Mobilization in multiple myeloma - The GENESIS Study
    A.4.1Sponsor's protocol code numberBL-8040.SCM.301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03246529
    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 SponsorBioLineRx Ltd.
    B.1.3.4CountryIsrael
    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 supportBioLineRx Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioLineRx Ltd.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressModi'in Technology Park, 2 HaMa'ayan Street
    B.5.3.2Town/ cityModi'in
    B.5.3.3Post code7177871
    B.5.3.4CountryIsrael
    B.5.4Telephone number+9728642-9100
    B.5.5Fax number+9728642-9117
    B.5.6E-mailinbalg@biolinerx.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 nameBL-8040
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmotixafortide
    D.3.9.1CAS number 664334-36-5
    D.3.9.2Current sponsor codeBL-8040
    D.3.9.3Other descriptive nameBKT140; 4F-benzoyl-TN14003
    D.3.9.4EV Substance CodeSUB187495
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number36500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hematopoietic Stem Cell mobilization in Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Stem-cell collection for bone marrow transplant in subjects with cancer of blood cells
    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 demonstrate the superiority of one dose of BL-8040 + G-CSF over placebo + G-CSF to mobilize ≥6.0 x 10^6 CD34+ cells/kg in up to 2 apheresis sessions in preparation for autologous hematopoietic cell transplantation (auto-HCT) in MM subjects.
    E.2.2Secondary objectives of the trial
    - To demonstrate the superiority of one dose of BL-8040 + G-CSF over placebo + G-CSF to mobilize ≥2.0 x 10^6 CD34+ cells/kg in 1 apheresis session in preparation for autologous hematopoietic cell transplantation (auto-HCT) in MM subjects.
    - To demonstrate the superiority of one dose of BL-8040 + G-CSF over placebo + G-CSF to mobilize ≥6.0 x 10^6 CD34+ cells/kg in 1 apheresis session in preparation for autologous hematopoietic cell transplantation (auto-HCT) in MM subjects.
    - To descriptively assess the comparability between the effects of BL-8040 + G-CSF and placebo + G-CSF in time to neutrophil engraftment, platelet engraftment and the later of the two.
    - To descriptively assess the comparability between the effects of BL-8040 + G-CSF and placebo + G-CSF on graft durability at 100 days, 6 and 12 months post-engraftment.
    - To demonstrate that the use of (one or two doses) BL-8040 + G-CSF over placebo + G-CSF results in a reduction in resource use and cost savings.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be between the ages of 18 and 78 years.
    2. Patients must have a signed study informed consent prior to entering the study.
    3. Histologically confirmed Multiple Myeloma prior to enrollment and randomization.
    4. At least 1 week (7 days) from last induction cycle of combination/multi-agent chemotherapy (e.g. KRD [carfilzomib, lenalidomide, dexamethasone] or VRD [bortezomib, lenalidomide, dexamethasone]) or last single agent chemotherapy (e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc) prior to the first dose of G-CSF for mobilization.
    5. Eligible for Autologous Hematopoietic stem cell transplantation according to the investigator’s discretion.
    6. The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR).
    7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
    8. Adequate organ function at baseline as defined below:
    a. Hematology:
    • White blood cell count more than 2.5 x 10^9/L,
    • Absolute neutrophil count more than 1.5 x 10^9/L
    • Platelet count more than 100 x10^9/L
    b. Renal Function:
    • Serum creatinine ≤2.2 mg/dL or creatinine clearance (CrCl) value of ≥ 50 ml/min by MDRD equation, whichever is more stringent.
    c. Hepatic function:
    • ALT and/or AST ≤ 2.5 x ULN
    • Total Bilirubin ≤ 2.0 x ULN unless the subject has Gilbert disease
    d. Coagulation test:
    • INR or PT: ≤1.5xULN unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    • aPTT: ≤1.5xULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    9. Subjects must use effective contraception:
    e. Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as (by other than medical reasons):
    • ≥45 years of age and has not had menses for over 2 years.
    • Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a Follicle Stimulating Hormone (FSH) value in the postmenopausal range upon pre-trial (screening) evaluation.
    • Post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation at least 6 weeks prior to screening. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure otherwise the subject must be willing to use two adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study therapy. Information must be captured appropriately within the site's source documents.
    f. Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Previous history of autologous or allogeneic-HCT.
    2. Failed previous HSC collections or collection attempts.
    3. Patients whose apheresis product will have to be further selected and purified.
    4. Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period:
    a. Dexamethasone: 7 days
    b. Thalidomide: 7 days
    c. Lenalidomide: 7 days
    d. Pamolidomide: 7 days
    e. Bortezomib: 7 days
    f. Carfilzomib: 7 days
    g. G-CSF: 14 days
    h. GM-CSF or Neulasta®: 21 days
    i. Erythropoietin or erythrocyte stimulating agents: 30 days
    j. Eltrombopag, romiplostim or platelet stimulating agents: 30 days
    k. Carmustine (BCNU): 42 days/6 weeks
    l. Daratumumab-28 days
    5. Received >6 cycles lifetime exposure to Lenalidomide.
    6. Received >8 cycles of alkylating agent combinations
    7. Received > 6 cycles of melphalan.
    8. Received prior treatment with radioimmunotherapy, (e.g. radionuclides, holmium).
    9. Plans to receive maintenance treatment within 60 days post-engraftment (e.g. Lenalidomide, Bortezomib, Pomalidomide, Thalidomide, Carfilzomib, etc.).
    10. Has received a live vaccine within 30 days of the planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted.
    11. Known active CNS metastases or carcinomatous meningitis.
    12. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to BL-8040, G-CSF, or other agents used in the study.
    13. Has an active or uncontrolled infection requiring systemic therapy.
    14. Has a known additional malignancy that is progressing or requires active treatment.
    15. Has an underlying medical condition that would preclude study participation.
    16. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
    17. O2 saturation < 92% (on room air).
    18. Personal history or family history of Long QT Syndrome or Torsade de Pointes
    19. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden cardiac death.
    20. Myocardial infarction, CABG, coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months, Angina Pectoris Class >2 or NYHA Heart Failure Class >2.
    21. ECG at screening or baseline showing QTcF > 470 msec and/or PR > 280 msec.
    22. Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block, unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities.
    23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
    24. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    25. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 30 days after the last dose of trial treatment. Women with a positive pregnancy test within 72 hours from baseline.
    26. Has a known history of HIV (HIV 1/2 antibodies).
    27. Has known active Hepatitis B (e.g., Hepatitis B Surface Antigen [HBsAg] reactive) or Hepatitis C (e.g., Hepatitis C Virus [HCV] RNA [qualitative] is detected).
    28. Untreated or unsuccessfully treated Hepatitis B or C.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects mobilizing ≥6.0 x 10^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for auto-HCT after G-CSF + single administration of BL-8040 or Placebo + G-CSF.
    E.5.1.1Timepoint(s) of evaluation of this end point
    June 2020
    E.5.2Secondary end point(s)
    - Proportion of subjects who collect ≥2.0 x 10^6 CD34+ cells/kg in 1 apheresis session
    - Proportion of subjects who collect ≥6.0 x 10^6 CD34+ cells/kg in 1 apheresis session
    -Economic endpoints: resource utilization until engraftment and 100 days post engraftment
    E.5.2.1Timepoint(s) of evaluation of this end point
    June 2020
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Czech Republic
    Germany
    Hungary
    Italy
    Spain
    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
    June 2020 (last subject's visit 13, day 100 post-engraftment)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 97
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 207
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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