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

15 października 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

107

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Inne nazwy:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) do wstrzykiwań
Lek: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Inne nazwy:
  • Revlimid®
Lek: 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.
Eksperymentalny: 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.
Lek: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Inne nazwy:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) do wstrzykiwań
Lek: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Inne nazwy:
  • Revlimid®
Lek: 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.
Eksperymentalny: 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.
Lek: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Inne nazwy:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) do wstrzykiwań
Lek: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Inne nazwy:
  • Revlimid®
Lek: 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.
Eksperymentalny: 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.
Lek: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Inne nazwy:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) do wstrzykiwań
Lek: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Inne nazwy:
  • Revlimid®
Lek: 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.
Eksperymentalny: 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.
Lek: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Inne nazwy:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) do wstrzykiwań
Lek: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Inne nazwy:
  • Revlimid®
Lek: 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.
Eksperymentalny: 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.
Lek: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Inne nazwy:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) do wstrzykiwań
Lek: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Inne nazwy:
  • Revlimid®
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Adverse Events (AEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline and Cycle 2 day 1
Baseline and Cycle 2 day 1
Change From Baseline in Creatinine
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amgen

Śledczy

  • Dyrektor Studium: Amy Kimball, MD, Amgen

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 kwietnia 2015

Zakończenie podstawowe (Rzeczywisty)

28 października 2019

Ukończenie studiów (Rzeczywisty)

28 października 2019

Daty rejestracji na studia

Pierwszy przesłany

23 grudnia 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 stycznia 2015

Pierwszy wysłany (Oszacować)

12 stycznia 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 października 2020

Ostatnia weryfikacja

1 września 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CFZ013

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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