NCT01531751

Brief Summary

The aim of the study is to assess survival of patients with advanced cardiac AL amyloidosis treated with high cut-off hemodialysis (HCO-HD) combined with chemotherapy.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
3 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

January 11, 2012

Last Update Submit

March 20, 2018

Conditions

Primary Amyloidosis of Light Chain Type

Keywords

HCO-HDsurvivalcardiac biomarkersAL amyloidosisLight Chain Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Survival

    The primary objective will be to assess survival of patients with advanced cardiac AL amyloidosis treated with HCO-HD combined with chemotherapy.

    6 months

Secondary Outcomes (1)

  • tolerability of the experimental device

    1 month

Study Arms (1)

High Cut-off Hemodialysis

EXPERIMENTAL
Device: High Cut-off HemodialysisDrug: Chemotherapy

Interventions

High Cut-off HemodialysisDEVICE

During dialysis the patients will undergo the first cycle of chemotherapy according to the current standard of care for subjects with advanced cardiac AL amyloidosis. Measurements of FLC and cardiac biomarkers will be done before and after each dialysis session. High cutoff HD will be continued during the first chemotherapy cycle. After the first cycle the end-of-treatment evaluation will take place.

Also known as: Theralite
High Cut-off Hemodialysis
ChemotherapyDRUG

Chemotherapy will be based on alchilators, proteasome inhibitors, steroids, IMiDs.

High Cut-off Hemodialysis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of AL amyloidosis.
  • Age ≥ 18 years.
  • Evidence of a monoclonal light chain in serum and/or urine by positive immunofixation and abnormal FLC κ/λ ratio.
  • Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness \> 12 mm in the absence of other causes).
  • Cardiac stage III (both NT-proBNP \> 332 ng/L and cTnI \> 100 ng/L).
  • Estimated GFR \< 15 mL/min per 1.73 m2 or requiring dialysis.
  • NYHA class III or IV.
  • Initiation of chemotherapy for AL amyloidosis scheduled between day 3 and day 8 after first HCO-HD session.

You may not qualify if:

  • Non-AL (e.g. familial, senile) amyloidosis.
  • Concomitant non-amyloid related clinically significant cardiac diseases.
  • Involved (amyloidogenic) FLC \< 100 mg/L.
  • Inability to undergo chemotherapy for AL amyloidosis.
  • Uncontrolled infection.
  • Inability to give informed consent.
  • Previous or ongoing psychiatric illness (excluding reactive depression).
  • Pregnant or nursing women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S.Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

  • Hutchison CA, Cockwell P, Reid S, Chandler K, Mead GP, Harrison J, Hattersley J, Evans ND, Chappell MJ, Cook M, Goehl H, Storr M, Bradwell AR. Efficient removal of immunoglobulin free light chains by hemodialysis for multiple myeloma: in vitro and in vivo studies. J Am Soc Nephrol. 2007 Mar;18(3):886-95. doi: 10.1681/ASN.2006080821. Epub 2007 Jan 17.

    PMID: 17229909BACKGROUND

Related Links

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesParaproteinemias

Intervention Hierarchy (Ancestors)

Therapeutics
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Amyloidosis Research and Treatment Center

Study Record Dates

First Submitted

January 11, 2012

First Posted

February 13, 2012

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

IT(1)