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- Klinische proef NCT01969565
Study of Carfilzomib in Combination w/Dexamethasone in Patients w/Newly Diagnosed Multiple Myeloma
23 oktober 2017 bijgewerkt door: Jonathan Kaufman, Emory University
An Open-label, Single-arm, Phase 1b/ 2 Study of Carfilzomib in Combination With Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to evaluate the safety and tolerability of increasing doses of carfilzomib in combination with dexamethasone
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1
Fase
- Fase 2
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
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Winship Cancer Institute-Emory University
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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
Inclusion Criteria:
- Subjects must have newly diagnosed multiple myeloma immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin E (IgE) or immunoglobulin D (IgD) by the International Myeloma Foundation (IMF) 2003 Diagnostic Criteria
- Subjects must be treatment naïve.
- Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma.
- Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period).
- Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible.
- One week must have lapsed since last date of radiotherapy, which is recommended to be a limited field.
- Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and one week have passed since the last date of therapy.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment.
- Age 18 years at the time of signing Informed Consent.
- Life expectancy of more than three months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 or Karnofsky performance status of ≥ 60.
- Subject must be able to adhere to the study visit schedule and other protocol requirements.
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Female subjects of child-bearing potential must have a negative serum pregnancy test within seven days of the first dose and agree to use dual methods of contraception during and for 3 months following last dose of drug.
- Post menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test.
- Male subjects must use an effective barrier method of contraception during study and for three months following the last dose if sexually active with a female of child-bearing potential.
- Subjects must be able to receive outpatient treatment and laboratory monitoring at the institute that administers agent.
Exclusion Criteria:
- Patient has > Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment.
- Renal insufficiency as measured by calculated creatinine clearance < 15 mL/min by Cockroft-Gault formula.
- Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count 50,000 cells/mm³).
- Subjects with an absolute neutrophil count (ANC) < 1000 cells/mm³. Growth factors may not be used to meet ANC eligibility criteria.
- Total bilirubin > 2.0 mg/dL or bilirubin ≥ 2 x upper limit of normal (ULN).
- Subjects with a hemoglobin < 8.0 g/dL (Transfusion are permitted).
- Alanine aminotransferase (ALT) (SGPT) > 2.5 x ULN.
- Aspartate aminotransferase (AST) ≥ 2.5 x ULN.
- Major surgery within three weeks of starting study drug (Cycle 1 Day 1).
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
- Clinically relevant active infection requiring either oral or intravenous antibiotics or antifungal agents.
- Serious co-morbid medical conditions such as chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis.
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
- Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or if the expected survival from other malignancy is less than 90% at 5 years.
- Uncontrolled diabetes mellitus (Fasting Blood Sugar > 400 despite medical treatment).
- Known history of POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes).
- Known HIV infection.
- Known active hepatitis B or C viral infection.
- Plasma cell leukemia.
- Glucocorticoid therapy (prednisone > 20 mg/day or equivalent) within the last three weeks.
- Any prior treatment for multiple myeloma with standard regimens or investigative regimens.
- Subjects with treatment related myelodysplastic syndrome.
- Subjects in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing significant pulmonary, cardiac or renal impairment.
- Subjects with known primary amyloidosis.
- Female subject is pregnant or breast-feeding.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
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: 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 in combination with dexamethasone
Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve.
Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
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Andere namen:
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Tolerability and Safety of Increasing Doses of Carfilzomib in Combination With Dexamethasone.
Tijdsspanne: 24 months
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Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) adverse event dictionary.
The results will be tabulated to examine their frequency, organ systems affected, and relationship to study treatment.
The results of laboratory assessments will be evaluated similarly.
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24 months
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Patients With ≥ VGPR (Very Good Partial Response)
Tijdsspanne: 4 months-8 months
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VGPR will be estimated based on the crude proportion of subjects whose best response is Stringent Complete Response (sCR), Complete Response (CR), and VGPR.
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4 months-8 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate (ORR), Defined as sCR, CR, Very Good Partial Response (VGPR), and PR at 4 Cycles
Tijdsspanne: 4 months
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The ORR will be estimated based on the crude proportion of subjects for whom best overall response is sCR, CR, VGPR, and PR.
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4 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jonathan Kaufman, MD, Emory University
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
1 augustus 2013
Primaire voltooiing (Werkelijk)
1 oktober 2014
Studie voltooiing (Werkelijk)
1 oktober 2014
Studieregistratiedata
Eerst ingediend
4 september 2013
Eerst ingediend dat voldeed aan de QC-criteria
21 oktober 2013
Eerst geplaatst (Schatting)
25 oktober 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 november 2017
Laatste update ingediend die voldeed aan QC-criteria
23 oktober 2017
Laatst geverifieerd
1 oktober 2017
Meer informatie
Termen gerelateerd aan deze studie
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
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Ontstekingsremmende middelen
- Antineoplastische middelen
- Anti-emetica
- Gastro-intestinale middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Dexamethason
Andere studie-ID-nummers
- IRB00060113
- ISTCAR511 (Andere identificatie: Emory University)
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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Christian BuskeAmgen; Janssen, LPWervingWaldenström MacroglobulinemieOostenrijk, Duitsland, Griekenland
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AmgenMultiple Myeloma Research FoundationGoedgekeurd voor marketing