Optimising Renal Outcome in Myeloma Renal Failure

PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

April 20, 2020

Study Completion Date

April 20, 2020

Conditions
Multiple MyelomaChronic Kidney Disease
Interventions
DRUG

Bortezomib

"1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).~\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib"

DRUG

Thalidomide

100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)

DRUG

Bendamustine

60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)

DRUG

Dexamethasone

40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle

Trial Locations (9)

Unknown

Basingstoke & North Hampshire Hospital, Basingstoke

Heartlands Hospitals, Birmingham

St Helier Hospital, Epsom

Royal Liverpool Hospital, Liverpool

Kings College Hospital, London

Queen Alexandra Hospital, Portsmouth

Great Western Hospital, Swindon

CT1 3NG

Kent & Canterbury Hospital, Canterbury

OX3 7LE

Churchill Hospital, Oxford

All Listed Sponsors
collaborator

Janssen-Cilag Ltd.

INDUSTRY

collaborator

Bloodwise

OTHER

collaborator

University of Warwick

OTHER

collaborator

University of Birmingham

OTHER

lead

Oxford University Hospitals NHS Trust

OTHER

NCT02424851 - Optimising Renal Outcome in Myeloma Renal Failure | Biotech Hunter | Biotech Hunter