Condition category
Cancer
Date applied
21/09/2000
Date assigned
21/09/2000
Last edited
11/02/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G Gaskin

ORCID ID

Contact details

Renal Unit
Imperial College School of Medicine
Department of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)181 383 3152

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00416897

Protocol/serial number

C7625/A2879

Study information

Scientific title

A randomised controlled trial of adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure

Acronym

MERIT

Study hypothesis

As of 10/12/2009 this record was updated; all details can be found in the relevant fields under the above update date.

Added as of 10/12/2009:
Does the addition of plasma exchange (PE) to chemotherapy increase the likelihood of renal recovery in patients with acute renal failure associated with newly diagnosed myeloma?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Myeloma

Intervention

Plasma exchange in addition to standard chemotherapy versus standard chemotherapy alone.

Added as of 10/12/2009:
Chemotherapy (ALL patients): two 4-day courses of dexamethasone (d1-12), followed by four cycles of vincristine, Adriamycin and dexamethasone (VAD) (d17-83), with appropriate supportive therapy. Treatment after 100 days will be according to local preference.

Plasma exchange (patients randomised to PE): 7 plasma exchanges within the first two weeks of entry (at least 4 within the first week). Method of plasma exchange will be by either cytocentrifugation or plasma filtration, according to local practice.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Added as of 10/12/2009:
Proportion of patients alive and dialysis-independent at 100 days.

Secondary outcome measures

Added as of 10/12/2009:
1. To determine whether addition of plasma exchange to chemotherapy affects overall survival
2. To assess the impact of the addition of plasma exchange to chemotherapy on patients' quality of life
3. To assess the value of renal histology in predicting recovery of renal function
4. To assess the value of serum free light chain assay in determining response of the myeloma to chemotherapy and recovery of renal function in patients with renal failure

Overall trial start date

01/01/2004

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with newly diagnosed myeloma and acute renal failure, aged 18 years or over

Added as of 10/12/2009:
1. Newly diagnosed myeloma
2. Acute renal failure (creatinine greater than 500 mmol/l, urine output less than 400 ml/d or requiring dialysis)
3. Aged 18 years or over, either sex
4. Written informed consent
5. No previous chemotherapy for myeloma
6. No significant intrinsic renal disease unrelated to myeloma

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

280 (added 10/09/2007)

Participant exclusion criteria

Does not comply with above inclusion criteria

Recruitment start date

01/01/2004

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Renal Unit
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

c/o Clinical Trials Research Unit
University of Leeds
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Charity

Funder name

Leukaemia Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes