Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

September 14, 2023

Study Completion Date

September 14, 2023

Conditions
Multiple Myeloma
Interventions
DRUG

Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM

DRUG

Placebo 1.7 ml Subcutaneous Solution

Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM

Trial Locations (10)

1140

Hanusch Krankenhaus der Österreichischen Gesundheitskasse, 3. Med. Abteilung, Vienna

4021

Kepler Universitaetsklinikum Klinik f. Interne 3, Med Campus III, Linz

5020

IIIrd Medical Department, Private Medical University Hospital Salzburg, Salzburg

6020

Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V Hämatologie und Onkologie, Innsbruck

6511

Krankenhaus St. Vinzenz Zams, Innere Medizin, Internistische Onkologie und Hämatologie, Zams

97080

University Hospital Würzburg, Department of Internal Medicine 2, Würzburg

6423906

Tel Aviv Sourasky Medical Center, Department of Hematology,, Tel Aviv

A-8036

Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie, Graz

A-8700

LKH Hochsteiermark, Standort Leoben, Abteilung für Innere Medizin und Hämatologie und internistische Onkologie, Leoben

A-4020

BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie, Linz

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Assign Data Management and Biostatistics GmbH

OTHER

lead

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER