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    The EU Clinical Trials Register currently displays   43800   clinical trials with a EudraCT protocol, of which   7272   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2020-004001-32
    Sponsor's Protocol Code Number:EMN27
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-29
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004001-32
    A.3Full title of the trial
    A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis
    A.4.1Sponsor's protocol code numberEMN27
    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 Sponsor European Myeloma Network – EMN
    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 supportGlaxoSmithKline Research and Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Myeloma Network - EMN
    B.5.2Functional name of contact pointEMN
    B.5.3 Address:
    B.5.3.1Street AddressErasmus MC, dr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.4Telephone number00447767565020
    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 namebelantamab mafodotin
    D.3.2Product code GSK2857916
    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 INNbelantamab mafodotin
    D.3.9.1CAS number 2050232-20-5
    D.3.9.4EV Substance CodeSUB130430
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeBelantamab mafodotin is a humanized afucosylated, maleimidocaproyl monomethyl auristatin phenylalanine (mcMMAF) conjugated IgG1 antibody
    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
    Relapsed or refractory AL amyloidosis
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of blmf in patients with relapsed or refractory AL amyloidosis.
    E.2.2Secondary objectives of the trial
    1.The safety of blmf in patients with relapsed or refractory AL amyloidosis.
    a.Rates of AEs grade 3 or higher, related to blmf therapy
    b.Rates of treatment discontinuation due to toxicity related to blmf
    c.Dose reduction due to toxicity of blmf therapy
    d.Any grade hematologic AEs
    e.Any grade non-hematologic AEs
    f.Rates of AEs of special interest
    2.Secondary efficacy evaluations:
    a.Overall hematologic response rates
    b.Organ response rates per individual organ
    c.Time to first hematologic response
    d.Time to at least a very good hematologic response
    e.Time to at least a low-dFLC response
    f.Duration of hematologic response (time from first response to hematologic progression, for those who achieved at least a hematologic PR or low-dFLC response)
    g.Time to a subsequent therapy, either due to progression or inadequate response
    h.Time to hematologic progression or major organ deterioration or death
    i.Overall survival
    j.Quality of life
    3. Characterization of the blmf PK profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry, or if not available, for patients with biopsy confirmed amyloidosis and cardiac involvement alone, if they also have a negative PYP- or DPD-Tc99m bone scan.
    2.Patients must have had at least two cycles of therapy directed against plasma cell clone. However, patients that have received high dose therapy with melphalan as their only therapy are also eligible.
    3.Patients must be 18 years of age or above.
    4.ECOG performance status 0, 1 or 2.
    5.Mayo stage 1 or Mayo stage 2 or Mayo stage 3A1-3 defined as both cTnT < 0.035 ng/mL (or in place of cTnT the cTnI < 0.10 ng/mL or high sensitivity Troponin T < 54 ng/L) AND simultaneous NT-proBNP ≤ 332 ng/L, OR EITHER above threshold, or BOTH above threshold but with NTproBNP < 8500 ng/L (stage 3A disease)
    6.Supine systolic blood pressure ≥ 90 mmHg.
    7.Measurable disease defined by at least one of the following:
    a.serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L).
    b.presence of a monoclonal spike that is ≥0.5 g/dl.
    8.Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
    9. Patients must have adequate organ function.
    10.Written informed consent in accordance with local and institutional guidelines.
    11.Female patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    A female patient is eligible to participate if she is not pregnant or breast-feeding, and at least one of the following conditions applies:
    a.She is not of childbearing potential (WOCBP)
    b.She is a WOCBP and using, during the intervention period and for at least 4 months after the last dose of the study, a contraceptive method that is highly effective (failure rate <1% per year), preferably with low user dependency (as described in Appendix 3). Patient agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    A WOCBP must have a negative highly sensitive serum-pregnancy test (as required by local regulations) 72 hours before the first dose of the study intervention.
    The investigator is responsible for reviewing the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.
    Nonchildbearing potential is defined as follows (by other than medical reasons):
    a.≥45 years of age and has not had menses for >1 year
    b.Patients who have been amenorrhoeic for <2 years without a history of hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range after screening evaluation
    c.Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
    12. Male patients: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    Male patients are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:
    a.Refrain from donating sperm
    PLUS, either:
    b.Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
    c.Must agree to use contraception/barrier as detailed below:
    Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner agrees to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not pregnant.
    13. All toxicities related to previous treatment (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 5, corneal toxicities are defined according to the Keratopathy Visual Activity [KVA] scale), must be ≤ Grade 1 at the time of enrolment except for alopecia.
    14. Patient must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
    E.4Principal exclusion criteria
    1.Presence of non-AL amyloidosis.
    2.Presence of lytic bone lesions or active myeloma with hypercalcemia, cast nephropathy, anemia due to marrow infiltration or extramedullary disease > 60% plasma cells in bone marrow.
    3.Previous exposure to anti-BCMA agents.
    4.Cardiac stage IIIB disease: both cTnT > 0.035 ng/mL (or in place of cTnT the cTnI > 0.10 ng/mL or high sensitivity Troponin T > 54 ng/L) AND simultaneous NT-proBNP >8500 ng/L.
    5.Known repetitive ventricular arrhythmias on 24h Holter Electrocardiograms (ECG) despite anti-arrhythmic treatment. Patient must not have evidence of cardiovascular risk including any of the following:
    •Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
    •History of myocardial infarction, acute coronary syndromes (including unstable or uncontrolled angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
    •Class III or IV heart failure as defined by the New York Heart Association functional classification system (NYHA, 1994).
    •Severe uncontrolled ventricular arrhythmias, sick sinus syndrome, electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities (unless patient has a pacemaker).
    •Uncontrolled hypertension or hypotension (i.e., supine SBP< 90 mmHg despite supportive therapy with midodrine)
    6.Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to Cycle 1 Day 1.
    7.Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to Cycle 1 Day 1.
    8.Ongoing corneal epithelial disease except mild changes in corneal epithelium.
    9.Current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia (except due to related nephrotic syndrome), esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
    10.Active renal condition (infection, requirement for dialysis or any other condition that could affect the patient’s safety) unrelated to AL amyloidosis. Patients with isolated proteinuria resulting from AL are eligible, provided they fulfil other inclusion criteria.
    11.Patient must not use contact lenses while participating in this study.
    12.Patient must not be simultaneously enrolled in any interventional clinical trial.
    13.Use of an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, prior to the first dose of study drug.
    14.Plasmapheresis within seven days prior to the first dose of the study treatment.
    15.Treatment with a monoclonal antibody within 30 days prior to the first dose of the study treatment. Serious conditions unrelated to AL, such as SARS-CoV-2, may be permitted but need to be discussed with the medical doctor and study-site personnel.
    16.Major surgery ≤ 4 weeks prior to initiating study treatment.
    17.Evidence of active mucosal or internal bleeding
    18.Known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to blmf or drugs chemically related to blmf, or any of the components of the study treatment.
    19.Active infection requiring treatment.
    20.Known HIV infection (defined as positive testing for human immunodeficiency virus [HIV] antibodies).
    21.Positive test for hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of study treatment.
    22.Positive test for hepatitis C antibody hepatitis C RNA at screening or within 3 months prior to the first dose of the study treatment.
    23.Invasive malignancies other than the disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of the clinical trial treatments of the currently targeted malignancy. Patients with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
    24.Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with the patient’s safety, informed consent or compliance to the study procedures.
    25.Patients must not be pregnant or breast-feeding.
    26.Participant must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the study is the CR/VGPR/low-dFLC response rate at 6 months/ 4 cycles from start of therapy with blmf, according to consensus response criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months/ 4 cycles from start of therapy with blmf
    E.5.2Secondary end point(s)
    •Evaluation of safety (grade 3 or higher adverse events rates related to blmf therapy, treatment discontinuation rates, any grade hematologic adverse events, any grade non-hematologic adverse events) and
    •Further evaluation of efficacy (Overall hematologic response rates at 6 months (CR+VGPR+low-dFLC response+ PR), Organ response rates per individual organ (heart, kidney, liver) at 3, 6, 12, 18 and 24 months from start of therapy, Time to first hematologic response (PR or better), Time to at least a very good hematologic response (VGPR or better), Time to at least a low-dFLC response, Duration of hematologic response (time from first response to hematologic progression, for those who achieved at least a hemPR or low-dFLC response), Time to a subsequent therapy, either due to progression or inadequate response, Time to hematologic progression or major organ deterioration or death, overall survival and quality of life))"
    •Derived PK parameter values for belantamab mafodotin as data permit.
    Exploratory Endpoints:
    •Relation between baseline bone marrow BCMA expression levels/soluble BCMA (sBCMA) levels AND clinical response.
    •Change from baseline of sBCMA levels.
    E.5.2.1Timepoint(s) of evaluation of this end point
    for the entire duration 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 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. 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.8.2.4Number of treatment arms in the trial1
    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 EEA5
    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 Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years4
    E.8.9.2In all countries concerned by the trial months0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 36
    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)
    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 Decision2021-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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