- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01481194
ACVDL Treatment for Patients With Newly Diagnosed Multiple Myeloma (ACVDL)
27. februar 2019 oppdatert av: Vejle Hospital
An Open-Label Phase II Study of the Safety and Efficacy of Doxorubicin and Cyclophosphamide in Combination With Bortezomib, Lenalidomide, and Dexamethasone for Treatment of Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of the combination treatment of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide in newly diagnosed multiple myeloma patients.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
35
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Vejle, Danmark
- Department of Hematology
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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:
- Male or female subjects ≥ 18 years at the time of signing informed consent.
Subject is diagnosed with symptomatic multiple myeloma based on the International Myeloma Working Group Diagnostic Criteria (Kyle 2009):
- Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma.
- Monoclonal protein present in the serum and/or urine. If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma is required.
- Myeloma-related organ dysfunction
The myeloma disease burden must be measurable with at least one of the following criteria (Durie et al. 2006):
- Serum M-protein ≥ 10 g/l
- Urine M-protein ≥ 200 mg/24 h
- Involved FLC ≥ 100 mg/l provided serum FLC ratio is abnormal
- Bone marrow plasma cells > 30%
- Subject has a Karnofsky performance status of ≥ 60.
- 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.
- Subject is willing and able to comply with the protocol as judged by the investigator.
Exclusion Criteria:
- Any prior systemic therapy for multiple myeloma.
- Other therapies such as biologic therapy and chemotherapy less than 3 months prior to screening.
- Any prior treatment with doxorubicin or other anthracycline.
- Concurrent or recent (less than 2 weeks prior to Screening) radiotherapy or surgery.
- Prior glucocorticoid treatment of multiple myeloma exceeding dexamethasone 20mg/day for a maximum of 7 days. Topical glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
- More than or equal to grade 2 peripheral neuropathy according to the NCI-CTC criteria on clinical examination within 14 days before enrolment (Day 1 of Cycle 1).
- Evidence of mucosal or internal bleeding and/or platelet counts < 50 x 10^9/l. Platelet transfusions may not be used to meet PLT eligibility criteria.
- Absolute neutrophil count (ANC) < 1 x 10^9/l. Growth factors may not be used to meet ANC eligibility criteria.
- Hemoglobin < 5.0 mmol/l. The subject may be included after correction of the hemoglobin level by transfusion or treatment with erythropoietin.
- Alanine aminotransferase (ALAT) > 2 x ULN.
- Myocardial infarction within 6 months prior to enrolment or New York Heart Association (NYHA) Class 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 or 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 except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer for which the subject has been disease-free for at least 3 years.
- Female subject is pregnant or breast-feeding. The first serum pregnancy test to be done within 10-14 days prior to the study treatment start and repeated serum pregnancy test to be done within 24 hours prior to the start of study treatment.
- Female subjects who are of childbearing potential (biologically capable of becoming pregnant) or men with partners of childbearing potential, who are unwilling or unable to use effective means of contraception. The means of contraception must be TWO acceptable methods of birth control, one highly effective method (hormonal contraceptives pills, injections or implants, tubal ligation, partner's vasectomy) and one additional effective method (condom, diaphragm, cervical cap) AT THE SAME TIME, at least 28 days before she or he starts ACVDL and for at least 28 days after the last dose of ACVDL.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled diabetes mellitus at the discretion of the investigator.
- Hypersensitivity and/or contraindication to any one of the Investigational Medicinal Products (IMP), acyclovir or similar anti-viral drug.
- 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.
- Known intolerance to steroid therapy.
- Current or recent (within 30 days prior to Screening) treatment with another investigational drug.
- Unable to comply with the administration of the study treatment.
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 |
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Eksperimentell: ACVDL
ACVDL is a combination of doxorubicin, cyclophosphamide, bortezomib, dexamethasone, and lenalidomide
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50 mg/m2 IV on day 1 of a 21-day cycle
1.3 mg/m2 IV push on days 2 and 9 of a 21-day cycle
15 mg orally on days 1-14 of a 21-day cycle
20 mg orally on days 2, 3, 9, and 10 of a 21-day cycle
750 mg/m2 IV on day 1 of a 21-day cycle
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Response rate
Tidsramme: 4 weeks after completion of 8 treatment cycles
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4 weeks after completion of 8 treatment cycles
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Progresjonsfri overlevelse
Tidsramme: 4 år
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4 år
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Tid til progresjon
Tidsramme: 4 år
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4 år
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Complete response rate
Tidsramme: 4 weeks after completion of 8 treatment cycles
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4 weeks after completion of 8 treatment cycles
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Very good partial response rate
Tidsramme: 4 weeks after completion of 8 treatment cycles
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4 weeks after completion of 8 treatment cycles
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Torben Plesner, DMSc, Vejle Hospital
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 (Faktiske)
1. november 2011
Primær fullføring (Faktiske)
1. mai 2014
Studiet fullført (Faktiske)
28. august 2018
Datoer for studieregistrering
Først innsendt
21. november 2011
Først innsendt som oppfylte QC-kriteriene
24. november 2011
Først lagt ut (Anslag)
29. november 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Multippelt myelom
- Neoplasmer, plasmacelle
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Antibiotika, antineoplastisk
- Deksametason
- Cyklofosfamid
- Lenalidomid
- Bortezomib
- Doxorubicin
Andre studie-ID-numre
- SDU/VS-HKU/CTC-2011-01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Multippelt myelom
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National Cancer Institute (NCI)FullførtMyelom-multippel | Myelom, plasmacelleForente stater
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National Cancer Institute (NCI)AvsluttetMyelom, multippel | Myelom-multippelForente stater
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMyelom-multippel | Myelom, plasmacelleForente stater
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National Cancer Institute (NCI)FullførtMyelom-multippel | Myelom, plasmacelleForente stater
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National Cancer Institute (NCI)Georgetown University; Hackensack Meridian HealthAvsluttetMyelom-multippel | Myelom, plasmacelle | MyelomatoseForente stater
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Tel-Aviv Sourasky Medical CenterFullførtPlasmacellemyelom | Myelom-multippel | Myelom multippel | Myelom, plasmacelleIsrael
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US Oncology ResearchKaryopharm Therapeutics IncRekrutteringMultippelt myelom | Plasmacellemyelom | Myelom-multippel | Myelom multippel | Kahlers sykdom | Myelom, plasmacelle | MyelomatoseForente stater
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Mayo ClinicFullførtMultippelt myelom | Stage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater
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University of ChicagoNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater, Canada
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Sidney Kimmel Cancer Center at Thomas Jefferson...FullførtStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater
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Ayana Pharma Ltd.,Lambda Therapeutic Research Ltd.FullførtTilbakevendende eggstokkreftIndia
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Grupo Español de Investigación en Cáncer de OvarioNeovii BiotechFullført
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InxMed (Shanghai) Co., Ltd.Aktiv, ikke rekrutterendeLokalt avanserte eller metastatiske solide svulsterKina
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National Institute of Allergy and Infectious Diseases...FullførtHIV-infeksjoner | Sarkom, KaposiForente stater
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French Innovative Leukemia OrganisationFullført