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

15 oktober 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

107

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andra namn:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) för injektion
Läkemedel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andra namn:
  • Revlimid®
Läkemedel: 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.
Experimentell: 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.
Läkemedel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andra namn:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) för injektion
Läkemedel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andra namn:
  • Revlimid®
Läkemedel: 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.
Experimentell: 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.
Läkemedel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andra namn:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) för injektion
Läkemedel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andra namn:
  • Revlimid®
Läkemedel: 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.
Experimentell: 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.
Läkemedel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andra namn:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) för injektion
Läkemedel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andra namn:
  • Revlimid®
Läkemedel: 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.
Experimentell: 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.
Läkemedel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andra namn:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) för injektion
Läkemedel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andra namn:
  • Revlimid®
Läkemedel: 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.
Experimentell: 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.
Läkemedel: Carfilzomib
Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
Andra namn:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) för injektion
Läkemedel: Lenalidomide
Administered orally once daily on days 1-21 of each 28-day cycle.
Andra namn:
  • Revlimid®
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events (AEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and Cycle 2 day 1
Baseline and Cycle 2 day 1
Change From Baseline in Creatinine
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Amgen

Utredare

  • Studierektor: Amy Kimball, MD, Amgen

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 april 2015

Primärt slutförande (Faktisk)

28 oktober 2019

Avslutad studie (Faktisk)

28 oktober 2019

Studieregistreringsdatum

Först inskickad

23 december 2014

Först inskickad som uppfyllde QC-kriterierna

7 januari 2015

Första postat (Uppskatta)

12 januari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 oktober 2020

Senast verifierad

1 september 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CFZ013

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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