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- Klinische proef NCT01980589
A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects (CHAMPION 2)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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California
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Encinitas, California, Verenigde Staten
- California Cancer Associates for Research and Excellence
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West Hollywood, California, Verenigde Staten
- James R. Berenson, MD
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Whittier, California, Verenigde Staten
- The Oncology Institute of Hope and Innovation
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Indiana
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Lafayette, Indiana, Verenigde Staten
- Horizon Oncology Research
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Maryland
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Bethesda, Maryland, Verenigde Staten
- Center For Cancer And Blood Disorders
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New York
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New York, New York, Verenigde Staten
- Clinical Research Alliance
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Tennessee
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Nashville, Tennessee, Verenigde Staten
- Tennessee Oncology
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Texas
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Austin, Texas, Verenigde Staten
- Texas Oncology
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Virginia
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Norfolk, Virginia, Verenigde Staten
- Virginia Oncology Associates
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Newly diagnosed multiple myeloma
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
- Males and females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hepatic function
- Left ventricular ejection fraction (LVEF) ≥ 40%
- Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
- Platelet count ≥ 50 × 10^9/L
- Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min
Exclusion Criteria:
- Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma
- Multiple myeloma of immunoglobulin M (IgM) subtype
- Prior systemic treatment for multiple myeloma
- Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg
- Known amyloidosis
- 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.
- 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)
- Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
Andere namen:
Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.
Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Dose-limiting Toxicities (DLTs)
Tijdsspanne: First cycle treatment over 28-days
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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:
Hematologic:
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First cycle treatment over 28-days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate (ORR)
Tijdsspanne: Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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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.
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Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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Time To Response (TTR)
Tijdsspanne: Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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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.
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Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
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Number of Participants With Adverse Events
Tijdsspanne: From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.
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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.
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Hematologische ziekten
- Hemorragische aandoeningen
- Hemostatische aandoeningen
- Paraproteïnemieën
- Bloed eiwit stoornissen
- Multipel myeloom
- Neoplasmata, plasmacel
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Ontstekingsremmende middelen
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Anti-emetica
- Gastro-intestinale middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Dexamethason
- Cyclofosfamide
Andere studie-ID-nummers
- 2012-003
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 .
Klinische onderzoeken op Multipel myeloom
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University of ArkansasVoltooidMEERDERE MYELOMAVerenigde Staten
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PETHEMA FoundationGlaxoSmithKlineWervingTERUGVALLEN EN/OF REFRACTAIRE MEERDERE MYELOMASpanje
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Mario BoccadoroActief, niet wervend
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Beth Israel Deaconess Medical CenterAmgenVoltooidAML | MDS | CLL | ALLE | CML Chronic Phase, Accelerated Phase, or Blast Crisis | RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA | APLASTIC ANEMIA | MEERDERE MYELOMA | MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)
Klinische onderzoeken op Carfilzomib
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Ajai ChariAmgenVoltooidRefractair multipel myeloom | Terugval Multipel MyeloomVerenigde Staten
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M.D. Anderson Cancer CenterOnyx Therapeutics, Inc.BeëindigdLymfoomVerenigde Staten
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University of ArkansasOnyx Therapeutics, Inc.Niet meer beschikbaar
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AmgenVoltooidMultipel myeloomVerenigde Staten, Canada
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AmgenVoltooidMultipel myeloomVerenigde Staten, Canada
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Thomas LundWerving
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Washington University School of MedicineVoltooidLeukemieVerenigde Staten
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NovartisAmgenBeëindigd
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AmgenMultiple Myeloma Research FoundationGoedgekeurd voor marketing
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AmgenVoltooidNierziekte in het eindstadium | Recidiverend multipel myeloomVerenigde Staten, Australië, Canada