JOURNAL ONKOLOGIE – STUDIE
Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients
Rekrutierend
NCT-Nummer:
NCT03001804
Studienbeginn:
Juli 2017
Letztes Update:
17.09.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Celgene
Collaborator:
-
Studienleiter
Study Director
Celgene Corporation
Kontakt
Kontakt:
Phone: 1-888-260-1599
E-Mail: clinicaltrialdisclosure@celgene.com» Kontaktdaten anzeigen
Studienlocations (3 von 12)
Landeskrankenhaus Kirchdorf
4560 Kirchdorf
AustriaRekrutierend» Google-MapsKlinikum Klagenfurt am Wörthersee
9020 Klagenfurt
AustriaRekrutierend» Google-MapsKepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
4020 Linz
AustriaRekrutierend» Google-Maps
4560 Kirchdorf
AustriaRekrutierend» Google-MapsKlinikum Klagenfurt am Wörthersee
9020 Klagenfurt
AustriaRekrutierend» Google-MapsKepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
4020 Linz
AustriaRekrutierend» Google-Maps
Ordensklinikum Linz GmbH Elisabethinen
4020 Linz
AustriaRekrutierend» Google-MapsKrankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1
4910 Ried
AustriaRekrutierend» Google-MapsLandeskrankenhaus Steyr - Innere Medizin
4400 Steyr
AustriaRekrutierend» Google-MapsKlinische Abteilung für Hämatologie und Hämostaseologie
1090 Vienna
AustriaRekrutierend» Google-MapsSt. Josef Krankenhaus
1130 Vienna
AustriaRekrutierend» Google-MapsWilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
1160 Vienna
AustriaRekrutierend» Google-MapsSalzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin
4840 Vöcklabruck
AustriaRekrutierend» Google-MapsAKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
1090 Wien
AustriaRekrutierend» Google-MapsLKH Wiener Neustadt, Innere Medizin
2700 Wr. Neustadt
AustriaRekrutierend» Google-Maps
Alle anzeigen 4020 Linz
AustriaRekrutierend» Google-MapsKrankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1
4910 Ried
AustriaRekrutierend» Google-MapsLandeskrankenhaus Steyr - Innere Medizin
4400 Steyr
AustriaRekrutierend» Google-MapsKlinische Abteilung für Hämatologie und Hämostaseologie
1090 Vienna
AustriaRekrutierend» Google-MapsSt. Josef Krankenhaus
1130 Vienna
AustriaRekrutierend» Google-MapsWilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
1160 Vienna
AustriaRekrutierend» Google-MapsSalzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin
4840 Vöcklabruck
AustriaRekrutierend» Google-MapsAKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
1090 Wien
AustriaRekrutierend» Google-MapsLKH Wiener Neustadt, Innere Medizin
2700 Wr. Neustadt
AustriaRekrutierend» Google-Maps
Studien-Informationen
Detailed Description:Multiple myeloma is still a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but incurable disease. On average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant. In February 2015 REVLIMID® (lenalidomide) was approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Furthermore, in May 2019 REVLIMID® was approved in combination with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Looking in more detail at the combination of lenalidomide and dexamethasone, the role and especially the most adequate and effective dosage of dexamethasone in long term use with lenalidomide is not clearly defined or well characterised It is therefore of great relevance to gain insights into the clinical practice and the routine of dexamethasone management and dosing in long term use with Revlimid.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Signed Informed Consent
- Age ≥ 18 years
- Newly diagnosed Multiple Myeloma
- Not suitable for stem cell transplantation
- Appropriate methods of contraception according to the Risk Minimization Program (RMP)
- Adequate thrombosis prophylaxis
Exclusion Criteria:
- Pregnant and lactating females
- No other formal exclusion criteria according to most recent European Summary of Product Characteristics (SmPC)
Studien-Rationale
Primary outcome:1. Number of patients receiving dexamethasone after 6 months of treatment (Time Frame - up to 2 years):
Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment
Secondary outcome:
1. Number of patients with Deep Venous Thrombosis (VTE) prophylaxis (Time Frame - up to 2 years):
Number of patients that receive VTE prophylaxis
2. Over all response rate (ORR) (Time Frame - up to 2 years):
Number of patients that achieve a response
3. Adverse Events (AEs) (Time Frame - up to 2 years):
Number of patients with an adverse events
Studien-Arme
- Cohort A
Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity - Cohort B
Initial treatment (up to 8 cycles): Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsule by mouth (PO) on day 1 through 14 of a 21 day cycle, Bortezomib 1.3mg/m2 s.c. on day 1, 4, 8, and 11 of a 21 day cycle, and Dexamethasone 20mg PO on days 1,2,4,5,8,9,11,12 of a 21 day cycle; Successive Treatment: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity
Quelle: ClinicalTrials.gov