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Spots Global Cancer Trial Database for A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis

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Trial Identification

Brief Title: A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis

Official Title: A Single Arm Open Labeled Multicentre Phase 1b Dose Escalation Study of Carfilzomib Taken in Combination With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis

Study ID: NCT02545907

Conditions

Amyloidosis

Study Description

Brief Summary: This study evaluates the safety and efficacy of carfilzomib used in combination with thalidomide and dexamethasone in patients with relapsed AL amyloidosis. The trial begins with a dose escalation phase, in which the maximum tolerated and recommended dose will be determined. The trial will then open into an expansion phase in which the combination efficacy is assessed.

Detailed Description: Amyloidosis is a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function. The treatment of systemic AL amyloidosis has evolved to a risk adapted approach based on the end organ damage, particularly cardiac involvement, and the functional status of the patient. Intensive therapies like high dose melphalan followed by an autologous stem cell transplant are considered for patients with limited organ involvement, younger age and excellent functional status. The majority of patients with AL amyloidosis, however, will not be candidates for ASCT and are generally treated with combination chemotherapy. This therapy may include bortezomib, a proteasome inhibitor which is particularly effective in AL amyloidosis but which may have a severe side-effect profile. Carfilzomib is specific for the chymotrypsin-like active site of the 20S proteasome, is structurally and mechanistically distinct from bortezomib, and has demonstrated less reactivity against non-proteasomal proteases when compared to bortezomib. It also appears to be better tolerated. However, information regarding the use of carfilzomib in the treatment of AL amyloidosis is limited. In the dose escalation phase of this study, a minimum of 6 (3 at dose level 0 and 3 at dose level -1)and a maximum of 18 (6 at dose level 0, 1, and 2) patients will recruited in a 3+3 design with cohorts of between 3 and 6 patients, in order to determine maximum tolerated dose and recommended dose. At the recommended dose level identified, a further 20 (minimum) patients will be recruited to further assess safety and toxicities at the RD.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Derriford Hospital, Plymouth, Devon, United Kingdom

Royal Bournemouth General Hospital, Bournemouth, Dorset, United Kingdom

Guy's Hospital, London, Greater London, United Kingdom

Manchester Royal Infirmary, Manchester, Greater Manchester, United Kingdom

Southampton General Hospital, Southampton, Hampshire, United Kingdom

Leicester Royal Infirmary, Leicester, Leicestershire, United Kingdom

Norfolk and Norwich University Hospital, Norwich, Norfolk, United Kingdom

Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom

Freeman Hospital, Newcastle-upon-Tyne, Tyne And Wear, United Kingdom

Birmingham Queen Elizabeth Hospital, Birmingham, West Midlands, United Kingdom

Birmingham Heartlands Hospital, Birmingham, West Midlands, United Kingdom

St James' University Hospital, Leeds, West Yorkshire, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, , United Kingdom

The Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

Contact Details

Name: Ashutosh Wechalekar, Dr

Affiliation: University College London, National Amyloidosis Centre

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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