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Optimising Renal Outcome in Myeloma Renal Failure | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Optimising Renal Outcome in Myeloma Renal Failure

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

NCT02424851•Oxford University Hospitals NHS Trust

View on ClinicalTrials.gov

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.

Detailed 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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant is willing and able to give informed consent for participation in the trial.
•Patients attending NHS (National Health Service) Haemato-oncology centres.
•Patients with newly diagnosed symptomatic myeloma.
•Glomerular Filtration Rate (GFR) \<30 mls/min.
•Chronic kidney disease (CKD) staging is based on estimated or measured GFR. CKD stage 4 (15-29 ml/min) and CKD stage 5 (\<15 ml/min) are eligible to enter the study. It is expected centres will consider use of fluid resuscitation and pulsed dose of steroid therapy in this group of patients to salvage renal function prior to trial screening.
•A number of patients with newly diagnosed myeloma and renal failure will have a pre-existing medical condition (hypertension, diabetes etc.) causing renal damage. Where there is a medical condition (e.g. hypertension, diabetes) which may cause renal damage, there must have been a further decline (≥15 mls/min GFR) between previous steady state and the study screening.
•Female participants of childbearing potential and male patients whose partner is a woman of childbearing potential must be prepared to use contraception in accordance with (and consent to) the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention Programme.
•Women of childbearing potential must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention.
•Free of prior malignancies for ≥ 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, localised prostate cancer or carcinoma "in-situ" of the cervix or breast.
•In the Investigator's opinion, is able and willing to comply with all trial requirements.
+1 more criteria

Exclusion Criteria

•Female participant who is pregnant, lactating or planning pregnancy during the course of the trial or the female partner of a male participant planning a pregnancy during the course of the trial.
•Known allergy to investigational drugs.
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
•Any of the following laboratory abnormalities:
•Absolute neutrophil count (ANC) \< 1.0 x10\^9/L
•Platelet count \<75 x 10\^9/L
•Serum SGOT/AST or SGPT/ALT (serum glutamic oxaloacetic transaminase/aspartate aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase) \>3 x upper limit of normal.
•Use of any standard/experimental anti-myeloma drug therapy excluding dexamethasone 14 days prior to trial entry.
•CKD stages \< 4.
•Intention to use a physical method of serum free light chain removal such as plasma exchange or high cut off dialysis.
+3 more criteria

Locations (9)

Basingstoke & North Hampshire Hospital

Basingstoke, United Kingdom

Heartlands Hospitals

Birmingham, United Kingdom

Kent & Canterbury Hospital

Canterbury, United Kingdom

St Helier Hospital

Epsom, United Kingdom

Royal Liverpool Hospital

Liverpool, United Kingdom

Kings College Hospital

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom

Great Western Hospital

Swindon, United Kingdom

Key Dates

Start Date

November 1, 2014

Primary Completion Date

April 20, 2020

Completion Date

April 20, 2020

Last Updated

January 27, 2022

Enrollment

ACTUAL participants

Conditions

Multiple MyelomaChronic Kidney Disease

Interventions

Bortezomib

DRUG

Thalidomide

DRUG

Bendamustine

DRUG

Dexamethasone

DRUG

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

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RECRUITINGPHASE2

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

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Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optimising Renal Outcome in Myeloma Renal Failure

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel