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Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma

15 oktober 2020 bijgewerkt door: Amgen

Phase 1b Study of Carfilzomib Administered Once Weekly in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma

The purpose of the study is to assess the safety, tolerability and activity of a once-weekly regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

107

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Bakersfield, California, Verenigde Staten, 93309
        • Research Site
      • Bakersfield, California, Verenigde Staten
        • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
      • Burbank, California, Verenigde Staten, 91505
        • Research Site
      • Burbank, California, Verenigde Staten
        • Providence Saint Joseph Medical Center
      • Fountain Valley, California, Verenigde Staten, 92708
        • Research Site
      • Fountain Valley, California, Verenigde Staten
        • Compassionate Care Research Group, Inc.
      • Los Angeles, California, Verenigde Staten, 90017
        • Research Site
      • Los Angeles, California, Verenigde Staten, 90095-1686
        • Research Site
      • Los Angeles, California, Verenigde Staten
        • Los Angeles Hematology / Oncology Medical Group
      • Whittier, California, Verenigde Staten, 90603
        • Research Site
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • Research Site
      • Aurora, Colorado, Verenigde Staten
        • University of Colorado
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20057
        • Research Site
      • Washington, District of Columbia, Verenigde Staten
        • Lombardi Cancer Center, Pediatric Hematology Oncology
    • Florida
      • Fort Myers, Florida, Verenigde Staten
        • Florida Cancer Specialists
      • Fort Myers, Florida, Verenigde Staten, 33905
        • Research Site
      • Tampa, Florida, Verenigde Staten, 33612
        • Research Site
      • Tampa, Florida, Verenigde Staten
        • H. Lee Moffitt Cancer Center & Research Institute
      • West Palm Beach, Florida, Verenigde Staten, 33401
        • Research Site
      • West Palm Beach, Florida, Verenigde Staten
        • Florida Cancer Specialists
    • Illinois
      • Chicago, Illinois, Verenigde Staten
        • University Of Chicago Medical Center
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Research Site
      • Boston, Massachusetts, Verenigde Staten
        • Dana Farber Partners Cancer Care
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • Research Site
      • Hackensack, New Jersey, Verenigde Staten
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • New York, New York, Verenigde Staten, 10021
        • Research Site
      • New York, New York, Verenigde Staten, 10065
        • Research Site
      • New York, New York, Verenigde Staten
        • Memorial Sloan Kettering
      • New York, New York, Verenigde Staten
        • Weill Cornell Medical College
      • New York, New York, Verenigde Staten
        • Clinical Research Alliance
      • New York, New York, Verenigde Staten
        • Morton Coleman, MD
      • Stony Brook, New York, Verenigde Staten, 11794
        • Research Site
      • Stony Brook, New York, Verenigde Staten
        • Stony Brook University Medical Center
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27705
        • Research Site
      • Durham, North Carolina, Verenigde Staten
        • Durham Veterans Affairs Medical Center
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45242
        • Research Site
      • Cincinnati, Ohio, Verenigde Staten
        • Sarah Cannon Research Institute
    • Oregon
      • Bend, Oregon, Verenigde Staten, 97701
        • Research Site
      • Bend, Oregon, Verenigde Staten
        • Bend Memorial Clinic
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29424
        • Research Site
      • Charleston, South Carolina, Verenigde Staten
        • Medical University of South Carolina, Hollings Cancer Center
      • Greenville, South Carolina, Verenigde Staten, 29607
        • Research Site
      • Greenville, South Carolina, Verenigde Staten
        • Greenville Health System
      • Greenville, South Carolina, Verenigde Staten
        • Saint Francis Hospital Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, Verenigde Staten, 57105
        • Research Site
      • Sioux Falls, South Dakota, Verenigde Staten
        • Avera Cancer Institute
    • Tennessee
      • Germantown, Tennessee, Verenigde Staten, 38138
        • Research Site
      • Memphis, Tennessee, Verenigde Staten
        • The West Clinic, PC
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Research Site
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Research Site
      • Nashville, Tennessee, Verenigde Staten
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Verenigde Staten
        • Tennessee Oncology, PLLC / The Sarah Cannon Research lnstitute
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84112
        • Research Site
      • Salt Lake City, Utah, Verenigde Staten
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Research Site
      • Seattle, Washington, Verenigde Staten
        • Swedish Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten
        • Aurora Health Care, Aurora Cancer Care
      • Wauwatosa, Wisconsin, Verenigde Staten, 53226
        • Research Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Key Inclusion Criteria:

  1. Newly diagnosed or relapsed multiple myeloma
  2. Measureable disease by serum M protein, or urine M protein, or serum free light chain (SFLC) and an abnormal serum kappa lambda ratio (for subjects without detectable serum or urine M-protein), or serum quantitative immunoglobulin A (glgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliable measured by qlgA).
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
  4. Left ventricular ejection fraction (LVEF) ≥ 40%

Key Exclusion Criteria:

  1. Waldenström macroglobulinemia
  2. For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype

  3. For relapsed disease:

    1. If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
    2. Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy.
    3. Any prior treatment with carfilzomib
  4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  5. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
  6. Myelodysplastic syndrome
  7. Amyloidosis
  8. Prior treatment with carfilzomib or oprozomib

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: RRMM Dose-evaluation: Carfilzomib 56 mg/m²

Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.

Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Geneesmiddel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andere namen:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) voor injectie
Geneesmiddel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andere namen:
  • Revlimid®
Geneesmiddel: Dexamethasone
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
Experimenteel: RRMM Dose-evaluation: Carfilzomib 70 mg/m²

Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.

Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Geneesmiddel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andere namen:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) voor injectie
Geneesmiddel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andere namen:
  • Revlimid®
Geneesmiddel: Dexamethasone
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
Experimenteel: RRMM Dose-expansion: Carfilzomib 70 mg/m²

Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.

Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Geneesmiddel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andere namen:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) voor injectie
Geneesmiddel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andere namen:
  • Revlimid®
Geneesmiddel: Dexamethasone
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
Experimenteel: NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²

Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.

Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Geneesmiddel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andere namen:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) voor injectie
Geneesmiddel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andere namen:
  • Revlimid®
Geneesmiddel: Dexamethasone
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
Experimenteel: NDMM Dose-expansion: Carfilzomib 70 mg/m²

Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.

Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Geneesmiddel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andere namen:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) voor injectie
Geneesmiddel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andere namen:
  • Revlimid®
Geneesmiddel: Dexamethasone
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
Experimenteel: NDMM Dose-expansion: Carfilzomib 56 mg/m²

Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.

Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
Geneesmiddel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andere namen:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) voor injectie
Geneesmiddel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andere namen:
  • Revlimid®
Geneesmiddel: Dexamethasone
Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Adverse Events (AEs)
Tijdsspanne: From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.

Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events.

An AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment.

A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:

  • fatal
  • life threatening
  • requires in-patient hospitalization or prolongation of existing hospitalization
  • results in persistent or significant disability/incapacity
  • congenital anomaly/birth defect
  • other medically important serious event

The severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
Change From Baseline in Hemoglobin Levels
Tijdsspanne: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Change From Baseline in Platelet Count
Tijdsspanne: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Change From Baseline in Neutrophil Count
Tijdsspanne: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Change From Baseline in Bilirubin
Tijdsspanne: Baseline and Cycle 2 day 1
Baseline and Cycle 2 day 1
Change From Baseline in Creatinine
Tijdsspanne: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Tijdsspanne: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Tijdsspanne: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Tijdsspanne: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion
Overall Response Rate (ORR)
Tijdsspanne: Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.

Response was determined by the investigator based on the International Myeloma Working Group Uniform Response Criteria (IMWG URC). ORR was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Responses must have been confirmed in 2 consecutive assessments at any time prior to initiation of any new therapy.

Disease assessments included serum protein electrophoresis (SPEP) with immunofixation, urine protein electrophoresis (UPEP; 24-hour assessment) with immunofixation, serum free light chain (SFLC), quantitative immunoglobulins, bone marrow aspirates to determine percent plasma cell involvement, and skeletal imaging for plasmacytoma evaluation.
Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
Complete Response Rate (CRR)
Tijdsspanne: Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.

Complete Response Rate (CRR) is defined as the percentage of participants who achieved a best overall response of either stringent complete response (sCR) or complete response (CR) in accordance with International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).

sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM) CR: Negative serum and urine immunofixation, disappearance of any soft tissue plasmacytomas, < 5% plasma cells in BM, and normal SFLC ratio in participants with measurable disease only by SFLC.
Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
Progression-free Survival (PFS)
Tijdsspanne: From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.

PFS is defined as the time from the first day of study treatment to the earlier of disease progression or death due to any cause.

Disease progression was determined by the investigator according to IMWG-URC. Progressive Disease (PD): Increase of 25% from lowest value in serum M-component (absolute increase ≥ 0.5 g/dL), urine M-component (absolute increase ≥ 200 mg per 24 hours) and/or the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, and/or any new or increase in size of bone lesions or soft tissue plasmacytomas, or development of hypercalcemia.

PFS was analyzed using Kaplan-Meier methods. Participants who were alive with no documented PD, started new anticancer therapy before documentation of PD or death, had death or PD immediately after > 1 consecutively missed assessment visit, were lost to follow-up or withdrew consent were censored at the date of last disease assessment.
From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
Duration of Response (DOR)
Tijdsspanne: From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.
Duration of response (DOR) was calculated for participants who achieved a confirmed PR or better based on Investigator assessment and according to the IMWG URC. Duration of overall response is defined as the time from first documentation of response to disease progression or death due to any cause. DOR was analyzed using Kaplan-Meier methods. Participants who were alive with no documented PD, started new anticancer therapy before documentation of PD or death, had death or PD immediately after > 1 consecutively missed disease assessment visit, were lost to follow-up, or withdrew consent were censored at the date of last disease assessment.
From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amgen

Onderzoekers

  • Studie directeur: Amy Kimball, MD, Amgen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 april 2015

Primaire voltooiing (Werkelijk)

28 oktober 2019

Studie voltooiing (Werkelijk)

28 oktober 2019

Studieregistratiedata

Eerst ingediend

23 december 2014

Eerst ingediend dat voldeed aan de QC-criteria

7 januari 2015

Eerst geplaatst (Schatting)

12 januari 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2020

Laatste update ingediend die voldeed aan QC-criteria

15 oktober 2020

Laatst geverifieerd

1 september 2020

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CFZ013

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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