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A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects (CHAMPION 2)

28. april 2017 oppdatert av: Amgen
The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

22

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Encinitas, California, Forente stater
        • California Cancer Associates for Research and Excellence
      • West Hollywood, California, Forente stater
        • James R. Berenson, MD
      • Whittier, California, Forente stater
        • The Oncology Institute of Hope and Innovation
    • Indiana
      • Lafayette, Indiana, Forente stater
        • Horizon Oncology Research
    • Maryland
      • Bethesda, Maryland, Forente stater
        • Center For Cancer And Blood Disorders
    • New York
      • New York, New York, Forente stater
        • Clinical Research Alliance
    • Tennessee
      • Nashville, Tennessee, Forente stater
        • Tennessee Oncology
    • Texas
      • Austin, Texas, Forente stater
        • Texas Oncology
    • Virginia
      • Norfolk, Virginia, Forente stater
        • Virginia Oncology Associates

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Newly diagnosed multiple myeloma

  2. Measurable disease, as defined by 1 or more of the following

    • Serum M-protein ≥ 0.5 g/dL, or
    • Urine M-protein ≥ 200 mg/24 hours, or
    • In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio
  3. Males and females ≥ 18 years of age
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  5. Adequate hepatic function
  6. Left ventricular ejection fraction (LVEF) ≥ 40%
  7. Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
  8. Platelet count ≥ 50 × 10^9/L
  9. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

Exclusion Criteria:

  1. Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma
  2. Multiple myeloma of immunoglobulin M (IgM) subtype
  3. Prior systemic treatment for multiple myeloma
  4. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg
  5. Known amyloidosis
  6. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment.
  7. Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed)
  8. Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment
  9. Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Carfilzomib, Cyclophosphamide and Dexamethasone (CCd)
Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
Legemiddel: Carfilzomib
Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².
Andre navn:
  • PR-171
  • PR171
  • Kyprolis® (carfilzomib) til injeksjon
Legemiddel: Cyclophosphamide
Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.
Legemiddel: Dexamethasone
Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Dose-limiting Toxicities (DLTs)
Tidsramme: First cycle treatment over 28-days

The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.

Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:

Nonhematologic:

  • ≥ Grade 3 non-hematological toxicity
  • ≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours

Hematologic:

  • Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days
  • Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration
  • Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment
  • Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding
First cycle treatment over 28-days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response Rate (ORR)
Tidsramme: Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.
Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Time To Response (TTR)
Tidsramme: Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.
Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Number of Participants With Adverse Events
Tidsramme: From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.

Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:

Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal.
From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amgen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2013

Primær fullføring (Faktiske)

1. mars 2016

Studiet fullført (Faktiske)

1. mars 2016

Datoer for studieregistrering

Først innsendt

28. oktober 2013

Først innsendt som oppfylte QC-kriteriene

4. november 2013

Først lagt ut (Anslag)

11. november 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2012-003

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Kliniske studier på Multippelt myelom

Kliniske studier på Carfilzomib

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Sponsorer og samarbeidspartnere

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Forhold

Sjeldne sykdommer

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Sponsor / samarbeidspartnere

Steder

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