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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    Summary
    EudraCT Number:2021-006646-12
    Sponsor's Protocol Code Number:POMAlternative
    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:2022-08-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-006646-12
    A.3Full title of the trial
    Alternative dosing scheme of pomalidomide 4 mg every other day versus pomalidomide 2 mg and 4 mg every day: reduction in costs, same efficacy? A PKPD bioequivalence pilot study.
    Alternatief doseringsschema van pomalidomide 4 mg om de dag versus pomalidomide 2 mg en 4 mg iedere dag; vermindering van de kosten, zelfde effect? Een PK/PD bioequivalentie studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Alternative dosing scheme of pomalidomide 4 mg every other day versus pomalidomide 2 mg and 4 mg every day: reduction in costs, same efficacy?
    Alternatief doseringsschema van pomalidomide 4 mg om de dag versus pomalidomide 2 mg en 4 mg iedere dag; vermindering van de kosten, zelfde effect?
    A.3.2Name or abbreviated title of the trial where available
    Alternative dosing scheme of pomalidomide 4 mg every other day; reduction in costs, same efficacy?
    Alternatief doseringsschema van pomalidomide; vermindering van de kosten, zelfde effect?
    A.4.1Sponsor's protocol code numberPOMAlternative
    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 SponsorAmsterdam UMC
    B.1.3.4CountryNetherlands
    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 supportAmsterdam UMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC
    B.5.2Functional name of contact pointClinical Trial Office Hematology
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3120444 2345
    B.5.6E-mailhemtrial@vumc.nl
    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 Pomalidomide (Imnovid)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Multipel myeloom of ziekte van Kahler
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma
    Multipel myeloom of ziekte van Kahler
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess in which percentage of patients the AUC is above the MIC and the level of the Ctrough above the EC50 during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1-21, and 2 mg QD on day 1-28 in cycles of 28 days.
    Bepalen in welk percentage van de patiënten de AUC boven de MIC en de Ctrough boven de EC50 is gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    E.2.2Secondary objectives of the trial
    - To assess other pharmacokinetic (PK) (i.e., maximum serum concentration (Cmax) and time above EC50) parameters during usage of pomalidomide 4 mg every day, pomalidomide 4 mg every other day, and pomalidomide 2 mg every day.
    - To assess toxicity and side effects during all to be studied dosages.
    - To assess response during all to be studied dosages.

    Explorative:
    - To assess the level of T-cell activation, defined as the expression of membrane activation markers and cytokine markers during usage of all to be studied dosages.
    - To assess Ikaros/Aiolos degradation levels as a biological measurement of pomalidomide activation during usage of all to be studied dosages.
    - To assess the concentration of pomalidomide in mononuclear cells (PBMCs) during usage of all to be studied dosages.
    - Bepalen van overige farmacokinetische parameters (maximale spiegel en tijd boven EC50) gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    - Bepalen van toxiciteit en bijwerkingen gedurende het gebruik van de drie verschillende doseerstrategieën.
    - Respons gedurende het gebruik van de drie verschillende doseerstrategieën.

    Exploratief:
    - Bepalen van T-cel activatie, gedefinieerd als de expressie van membraan activatie markers en cytokine markers gedurende het gebruik van de drie verschillende doseerstrategieën.
    - Bepalen van Ikaros/Aiolos degradatie als een biologische maat van activatie door pomalidomide gedurende het gebruik van de drie verschillende doseerstrategieën.
    - Bepalen van de concentratie van pomalidomide in "PBMC's" (Peripheral Blood Mononuclear Cells) gedurende het gebruik van de drie verschillende doseerstrategieën.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with relapsed/refractory multiple myeloma, who are eligible for a treatment regimen which contains pomalidomide. Either monotherapy or in combination with bortezomib, daratumumab, cyclophosphamide, or elotuzumab.
    • Patients who received a minimum of two cycles of pomalidomide 4mg every day on day 1-21/28.
    • Age > 18 years
    • WHO performance status 0-3
    • Written informed consent
    • Patiënten met een recidief multipel myeloom en voor wie een behandeling met pomalidomide mogelijk geacht wordt. Als monotherapie ofwel in combinatie met bortezomib, daratumumab, cyclofosfamide of elotuzumab.
    • Patiënten die minimaal twee cycli van 28 dagen pomalidomide 4mg iedere dag op dag 1-21 hebben gekregen.
    • Leeftijd > 18 jaar
    • WHO performance status 0-3
    • Informed consent getekend
    E.4Principal exclusion criteria
    • Usage of CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin, ketoconazole, carbamazepine, fluvoxamine, and grapefruit juice)
    • Renal insufficiency requiring dialysis
    • Significant hepatic dysfunction (total bilirubin =>30 micromol/l or transaminases => 3 times normal level)
    • Current smoker
    • Hemoglobin <6.5 mmol/L
    • Thrombocytes <100 *10^9/L
    • Neutrophiles <1.5 *10^9/L
    • Gebruik van CYP1A2 inhalerende middelen (bijvoorbeeld ciprofloxacin, enoxacin, ketoconazol, carbamazepine, fluvoxamine en grapefruit sap.
    • Nierinsufficiëntie waarvoor dialyse behoeftig
    • Significante leverfunctie stoornis (total bilirubine =>30micromol/l of transaminases =>3 keer de normaal waarde).
    • Patiënten die roken
    • Hemoglobine <6.5 mmol/L
    • Trombocyten <100 *10^9/L
    • Neutrofiele granulocyten <1.5 *10^9/L
    E.5 End points
    E.5.1Primary end point(s)
    The AUC/MIC ratio and the level of the Ctrough during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1-21, and 2 mg QD on day 1-28 in cycles of 28 days.
    De AUC/MIC ratio en de hoogte van de Ctrough gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated after the last of 12 patients completed the whole study.
    De primaire uitkomst zal worden geëvalueerd nadat alle 12 patiënten de studie volledig hebben volbracht.
    E.5.2Secondary end point(s)
    - Other PK parameters (Cmax and time above EC50) during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1- 21, and 2 mg QD on day 1-28 in cycles of 28 days.
    - Toxicity and side effects during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days.
    - Overall response rate (ORR)

    Explorative endpoints:
    - T-cell activation, defined as the expression of membrane activation markers and cytokine markers during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days.
    - Ikaros/Aiolos degradation as a biological measurement of pomalidomide activation during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days.
    - Concentration of pomalidomide in PBMCs during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days.
    - Overige farmacokinetische parameters (maximale spiegel en tijd boven EC50) gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    - Toxiciteit en bijwerkingen gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    - Respons

    Exploratieve uitkomstmaten:
    - T-cel activatie, gedefinieerd als de expressie van membraan activatie markers en cytokine markers gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    - Ikaros/Aiolos degradatie als een biologische maat van activatie door pomalidomide gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    - De concentratie van pomalidomide in "PBMC's" (Peripheral Blood Mononuclear Cells) gedurende het gebruik van pomalidomide 4mg iedere dag op dag 1 t/m 21, 4mg om de dag op dag 1 t/m 21 en 2mg iedere dag op dag 1 t/m 28 in cycli van 28 dagen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicity, side effects and response will be evaluated during and after completion of the study. All other endpoints will be evaluated after all 12 patients completed the study.
    Toxiciteit, bijwerkingen en respons zullen worden geëvalueerd gedurende en na het completeren van de studie. De overige uitkomsten worden geëvalueerd nadat alle 12 patiënten de studie hebben gecompleteerd.
    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 Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last visit last patient
    Laatste visite van de laatste patiënt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state12
    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)
    According to the Dutch treating guidelines concerning multiple myeloma.
    Volgens de Nederlandse behandelrichtlijnen voor multipel myeloom.
    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 Decision2024-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-10
    P. End of Trial
    P.End of Trial StatusOngoing
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