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    Summary
    EudraCT Number:2016-004282-31
    Sponsor's Protocol Code Number:V14-11056
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-03
    Trial results View 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 ConcernedFinland - Fimea
    A.2EudraCT number2016-004282-31
    A.3Full title of the trial
    VLX1570 and Low-Dose Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma: A Clinical and Correlative Phase 1/2 Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of VLX1570 and Dexamethasone in Myeloma Patients
    A.3.2Name or abbreviated title of the trial where available
    A Study of VLX1570 and Dexamethasone in Myeloma Patients
    A.4.1Sponsor's protocol code numberV14-11056
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02372240
    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 SponsorVivolux 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 supportVivolux AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVivolux AB
    B.5.2Functional name of contact pointAngelica Loskog
    B.5.3 Address:
    B.5.3.1Street Addressc/o Nexttobe AB Uppsala Science Park
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code751 83
    B.5.3.4CountrySweden
    B.5.4Telephone number+46735377161
    B.5.6E-mailangelica.loskog@nxt2b.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 nameVLX1570
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNVLX1570
    D.3.9.2Current sponsor codeVLX1570
    D.3.9.3Other descriptive nameVLX1570
    D.3.9.4EV Substance CodeSUB185142
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    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
    Phase I: To determine the maximum tolerated dose (MTD) of VLX1570 when used with low dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (RRMM).

    Phase II: To evaluate the clinical benefit rate (≥ minimal response, MR) of VLX1570 with low dose dexamethasone in RRMM.
    E.2.2Secondary objectives of the trial
    Phase I:
    • To determine the frequency and severity of adverse events associated with the combination of VLX1570 and low dose dexamethasone.
    • To evaluate the clinical pharmacokinetics of VLX1570.
    • To investigate if VLX1570 treatment at any dose results in objective response per International Myeloma Working Group (IMWG) criteria.

    Phase II:
    • To further characterize the toxicities associated with VLX1570 with low dose dexamethasone.
    • To determine the overall response rate (ORR), duration of response (DOR), progression free survival (PFS) and overall survival (OS) with this therapy.
    • To further evaluate the clinical pharmacokinetics of VLX1570.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of relapsed or relapsed and refractory multiple myeloma, or intolerant to established therapy following at least 2 prior therapies. Prior therapies must include at least one immunomodulatory drug (e.g., thalidomide, lenalidomide or pomalidomide) and one proteasome inhibitor (e.g., bortezomib or carfilzomib); i.e., regimens known to provide clinical benefits.
    2. Measurable disease defined by 1 or more of the following:
    a. Serum monoclonal protein ≥ 0.5 g/dL
    b. Urine monoclonal protein >200 mg/24 hour
    c. Serum immunoglobulin free light chain >10 mg/dL AND abnormal kappa/lambda ratio (reference 0.26-1.65)
    3. Estimated glomerular filtration rate (GFR) ≥30 mL/min as assessed by CKD-epi, MDRD, or the Cockcroft-Gault Equation (Appendix 4).
    4. Age ≥18 years.
    5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
    6. Females of child-bearing potential* must have a negative pregnancy test.
    * A female of childbearing potential (FCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
    7. Males and females of childbearing potential must be willing to use an effective form of contraception (see below) during chemotherapy treatment and for at least six months thereafter.
    Such methods include: (if using hormonal contraception this method must be supplemented with a barrier method, preferably male condom).
    o combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    o oral
    o intravaginal
    o transdermal
    o progestogen-only hormonal contraception associated with inhibition of ovulation:
    o oral
    o injectable
    o implantable
    o intrauterine device (IUD)
    o intrauterine hormone-releasing system ( IUS)
    o bilateral tubal occlusion
    o vasectomised partner
    o true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.
    8. Absolute neutrophil count (ANC) ≥1.0 x 109 /L, hemoglobin ≥8 g/dL (transfusion permitted provided the anemia is judged to be disease related), and platelet count ≥ 75 x 109/L.
    9. Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN.
    10. Patient has or is willing to have a central venous catheter (e.g., PICC, Port-A-Cath®, Hickman® catheter) for drug administration.
    E.4Principal exclusion criteria
    1. Any concurrent treatment that would compromise the study including but not limited to:
    a. Planned concurrent treatment for multiple myeloma other than bisphosphonates
    b. Ongoing corticosteroids for indications other than multiple myeloma allowed as long as the dose does not exceed 10 mg of prednisone per day or equivalent
    c. Persisting effects of any previous or ongoing treatment ≥ grade 1 that might compromise delivery of study treatment or assessment of adverse events (except alopecia or neuropathy ≤ grade 2 without pain)
    2. Any cytotoxic or biologic therapy less than 2 weeks prior to initiation of therapy.
    3. Pregnant or breast feeding females.
    4. Hypertension or diabetes not adequately controlled with current medication, defined as a need for dose adjustment or implementation of new or additional drugs as judged by the Investigator.
    5. Known active hepatitis B or C infection or HIV infection.
    6. Significant cardiovascular disease with NYHA Class III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or myocardial infarction within 6 months prior to enrollment, or unstable angina, or unstable arrhythmia.
    7. QTc interval >460 msec (males) or >470 msec (females); or repeated demonstration of a QTc interval >450 msec.
    8. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT syndrome).
    9. The use of concomitant medications that prolong the QT/QTc interval.
    10. Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that, in the opinion of the Investigator, would compromise compliance of study requirements or put the patient at unacceptable risk.
    11. Active infection requiring systemic treatment within one week prior to first dose.
    12. Major surgery within 1 month prior to enrollment.
    13. Use of any investigational agent within the last 28 days. For classes of investigational agents that are not known to have prolonged toxicities the wash-out time may be decreased to 14 days after agreement with the Medical Monitor.
    14. History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy for at least 2 years.
    15. Known intolerance to steroids or H1/H2-antagonists.
    16. Serum calcium (corrected for albumin) level above the ULN range (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal with standard treatment).
    17. Diagnosed with plasma cell leukemia, POEMS syndrome or amyloidosis.
    18. Patients with a history of central nervous system (CNS) myeloma or other CNS malignancy.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: To determine the maximum tolerated dose (MTD) of VLX1570 when used with low dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (RRMM).

    Phase II: To evaluate the clinical benefit rate (≥ minimal response, MR) of VLX1570 with low dose dexamethasone in RRMM.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During entire study.
    E.5.2Secondary end point(s)
    Phase I:
    • To determine the frequency and severity of adverse events associated with the combination of VLX1570 and low dose dexamethasone.
    • To evaluate the clinical pharmacokinetics of VLX1570.
    • To investigate if VLX1570 treatment at any dose results in objective response per International Myeloma Working Group (IMWG) criteria.

    Phase II:
    • To further characterize the toxicities associated with VLX1570 with low dose dexamethasone.
    • To determine the overall response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS) with this therapy.
    • To further evaluate the clinical pharmacokinetics of VLX1570.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During entire 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    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 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 No
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 62
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-09-18
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