Clinical Trials

Clinical Trial Program

ECWM-1 (https://clinicaltrials.gov/ct2/show/NCT01788020?term=ECWM-1&rank=1)

Study Design: Phase III, randomized, multicenter, international trial

Patients: treatment naive WM patients

Treatment: DRC versus Bortezomib-DRC

Status of the Study: Patient recruitment: closed (last patient in Sept 2018, n = 202)

Sponsor: University Hospital of Ulm, PI Christian Buske

ECWM-2 (https://clinicaltrials.gov/ct2/show/NCT03620903?term=ECWM-2&rank=1)

Study Design: Phase II, single arm, multicenter, international

Patients: treatment naive WM patients

Treatment: Bortezomib-Rituximab-Ibrutinib

Status of the Study: patient recruitment closed (last patient in November 2021, n= 53)

Sponsor: University Hospital of Ulm, PI Christian Buske

ECWM-3 (CZAR-1) (https://clinicaltrials.gov/ct2/show/NCT04263480?term=CZAR-1&draw=2&rank=1)

Study Design: Phase III, randomized, multicenter, international trial

Patients: treatment naive and relapsed WM patients

Treatment: Carfilzomib/Ibrutinib versus Ibrutinib

Status of the Study: recruiting (first patient in Feb 2021, n= 164)

Sponsor: University Hospital of Ulm, PI Christian Buske

HOVON124/ECWM-R2 trial (https://pubmed.ncbi.nlm.nih.gov/34388022/)

Study Design: Phase II, single arm, multicenter, European trial

Patients: relapsed WM patients

Treatment:  Ixazomib, rituximab and dexamethasone (IRD)

Status of the Study: completed, published

Sponsor: University Hospital Amsterdam, PI Marie Jose Kersten

ECWM-R3 (Remodel) (https://pubmed.ncbi.nlm.nih.gov/33961019/)

Study Design: Phase II, single arm, multicenter, French trial for treatment naive WM patients

Patients: relapsed WM patients

Treatment: Idelalisib-Obinutuzumab

Status of the Study: completed, published

Sponsor: Tour, France

Clinical Registry

Rory Morrison WMUK Registry for Waldenstrom's macroglobulinaemia (RMR) (https://wmuk.org.uk/research/rory-morrison-wmuk-registry/; https://wmuk.org.uk/wp-content/uploads/2021/11/Rory-Morrison-Report-2021-2-11-21-Final-Version.pdf)

Project Design: a clinical registry collecting real-world data from WM patients in the UK, to better understand patient experience and the impact of treatment; one of the largest of its kind in the world

Patient population: patients with Waldenstrom's macroglobulinaemia and other IgM-related conditions in the UK

Project status: rolled out 2018, duration 15 years

Sponsor: Waldenström's Macroglobulinaemia UK (WMUK)