MyEloma Renal Impairment Trial: adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure

ISRCTN	ISRCTN37161699
DOI	https://doi.org/10.1186/ISRCTN37161699
ClinicalTrials.gov (NCT)	NCT00416897
Protocol serial number	C7625/A2879
Sponsor	Imperial College London (UK)
Funders	Leukaemia Research Fund (UK), Cancer Research UK (CRUK) (UK)

Submission date: 21/09/2000
Registration date: 21/09/2000
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-plasma-exchange-in-patients-with-newly-diagnosed-multiple-myeloma-and-kidney-failure

Contact information

Dr G Gaskin
Scientific

Renal Unit
Imperial College School of Medicine
Department of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of adjunctive plasma exchange in patients with newly diagnosed multiple myeloma and acute renal failure
Study acronym	MERIT
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Added as of 10/12/2009: Proportion of patients alive and dialysis-independent at 100 days.
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	280
Key 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
Key exclusion criteria	Does not comply with above inclusion criteria
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Renal Unit

London
W12 0HS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes

Editorial Notes

25/10/2022: Internal review.
11/04/2019: Internal review.
14/02/2019: Publication reference added. (Cancer Research UK lay results summary)
26/11/2018: 19/10/2018: Cancer Research UK lay results summary link added to Results (plain English).