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Optimising Renal Outcome in Myeloma Renal Failure — OPTIMAL  

Multiple Myeloma Clinical Trial

Official title:
A Study of Thalidomide, Bendamustine and Dexamethasone (BTD) Versus Bortezomib, Bendamustine and Dexamethasone (BBD) in Patients With Renal Failure Defined as a GFR Below 30 Mls/Min

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of bortezomib versus thalidomide in reducing free light chains in the blood of myeloma patients. In addition participants will receive bendamustine (chemotherapy) and dexamethasone (steroids), which increase the effectiveness of both bortezomib and thalidomide. The trial will also study whether an earlier reduction of free light chains increases the chances of the kidneys recovering.

Clinical Trial Description

Renal impairment is a life threatening condition of myeloma. 20-25% of patients will present at diagnosis with renal dysfunction. Outcome is poor due to high early mortality, with 28% of newly diagnosed myeloma patients in myeloma trials with renal failure not surviving beyond 100 days, compared with 10% overall. This study aims to establish: 1. Whether proteosomal inhibition (bortezomib) or immunomodulatory (thalidomide) based therapy achieves threshold reduction of serum free light chains (sFLCs) in a significant majority of patients. 2. Whether sFLC response to the first 2 cycles (early responder) predicts haematological and renal response to the next 2 cycles of therapy. 3. An early time point for assessment of sFLC reduction as a biomarker for response. Participants will be stratified by age and chronic kidney disease (CKD) stage to receive either bortezomib, bendamustine and dexamethasone (BBD) or thalidomide, bendamustine and dexamethasone (BTD). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02424851
Study type Interventional
Source Oxford University Hospitals NHS Trust
Contact
Status Completed
Phase Phase 2
Start date November 2014
Completion date April 20, 2020
View Details
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