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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list