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 number | NCT00416897 |
| Secondary identifying numbers | C7625/A2879 |
- 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
Contact information
Dr G Gaskin
Scientific
Scientific
Renal Unit
Imperial College School of Medicine
Department of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2004 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 280 (added 10/09/2007) |
| 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
- England
- United Kingdom
Study participating centre
Renal Unit
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
c/o Clinical Trials Research Unit
University of Leeds
17 Springfield Mount
Leeds
LS2 9NG
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Leukaemia Research Fund (UK)
No information available
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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).
