Multiple Myeloma and Plasma Cell NeoplasmPhase 3NCT00416897
Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure
A Phase 3 study testing chemotherapy, dexamethasone and plasmapheresis in people with Multiple Myeloma and Plasma Cell Neoplasm and Renal Failure, run by University of Glasgow at 39 sites in United Kingdom.
Trial summary
RATIONALE: Dexamethasone is used to treat multiple myeloma. Drugs used in chemotherapy may stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm, Renal Failure
- What is being tested?
- chemotherapy, dexamethasone and plasmapheresis
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 39 sitesUnited Kingdom
- Study dates
- Mar 2003to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Newly diagnosed multiple myeloma (MM), meeting ≥ 2 of the following criteria:
- Serum or urine* paraprotein
- Bone marrow showing > 10% plasma cells
- Lytic bone lesions NOTE: *The presence of typical myeloma kidney on renal biopsy is considered equivalent to the demonstration of urine paraprotein by electrophoresis
- Acute renal failure attributable to MM, meeting both of the following criteria:
- Creatinine > 5.65 mg/dL OR urine output < 400 mL/day OR requires dialysis
- Unresponsive to treatment with fluids and/or treatment of hypercalcemia with bisphosphonates
- No significant intrinsic renal disease unrelated to MM
PATIENT CHARACTERISTICS:
- Platelet count ≥ 50,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN
- No contraindications to study medication, including the following:
- Active or recent peptic ulcer
- Known significant cardiac insufficiency
- Allergy to study medications
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known HIV positivity
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for MM
- Prior steroid therapy of ≤ 3 days duration for MM allowed
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United Kingdom39 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Monklands General Hospital
Airdrie, Scotland, ML6 0JF
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7BL
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
Good Hope Hospital
Birmingham, England, B75 7RR
Birmingham Heartlands Hospital
Birmingham, England, B9 5SS
Bradford Royal Infirmary
Bradford, England, BD9 6RJ
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, CT1 3NG
St. Helier Hospital
Carshalton, England, SM5 1AA
Saint Richards Hospital
Chichester, England, P019 4SE
Walsgrave Hospital
Coventry, England, CV2 2DX
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, DG1 4AP
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Harrogate District Hospital
Harrogate, England, HG2 7SX
Wycombe General Hospital
High Wycombe, England
Hull Royal Infirmary
Hull, England, HU3 2KZ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester General Hospital
Leicester, England, LE5 4PW
Aintree University Hospital
Liverpool, England, L9 7AL
Saint Bartholomew's Hospital
London, England, EC1A 7BE
St. Georges, University of London
London, England, SW17 ORE
Hammersmith Hospital
London, England, W12 OHS
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, NE7 7DN
Nottingham City Hospital
Nottingham, England, NG5 1PB
Oxford Radcliffe Hospital
Oxford, England, 0X3 7LJ
Hope Hospital
Salford, England, M6 8HD
Staffordshire General Hospital
Stafford, England, ST16 3SA
Sunderland Royal Hospital
Sunderland, England, SR4 7TP
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
Morriston Hospital NHS Trust
West Glamorgen, Scotland, SA6 6NL
New Cross Hospital
Wolverhampton, England, WV10 0QP
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
Cancer Care Centre at York Hospital
York, England, Y031 8HE
About this study
Official title: A Randomised Controlled Trial of Adjunctive Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Renal Failure [MERIT] MyEloma Renal Impairment Trial
RATIONALE: Dexamethasone is used to treat multiple myeloma. Drugs used in chemotherapy may stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Plasma exchange is a process in which certain cells are separated from the plasma in the blood by a machine and then only the cells are returned to the patient. Dexamethasone and plasma exchange may be an effective treatment for acute kidney failure caused by multiple myeloma. It is not yet known whether giving dexamethasone and chemotherapy together with plasma exchange is more effective than giving dexamethasone and chemotherapy alone in treating patients with multiple myeloma and acute kidney failure.
PURPOSE: This randomized phase III trial is studying dexamethasone, chemotherapy, and plasma exchange to see how well they work compared with dexamethasone and chemotherapy alone in treating patients with newly diagnosed multiple myeloma and acute kidney failure.
Read the detailed description
OBJECTIVES:
Primary
- Compare the effect of dexamethasone and cytotoxic chemotherapy with vs without plasma exchange on the likelihood of renal recovery (i.e., dialysis-independent at 100 days) in patients with newly diagnosed multiple myeloma and acute renal failure.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Determine the value of renal histology in predicting recovery of renal function in these patients.
- Determine the value of serum free light chain assay in determining disease response and renal function recovery in these patients.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to planned chemotherapy (vincristine and doxorubicin hydrochloride (VA) or VA-like chemotherapy vs thalidomide-containing chemotherapy vs alkylating agent vs other), frequency of chemotherapy courses (1-3 weekly vs 4 weekly), need for dialysis at randomization (yes vs no), and age (< 65 years vs ≥ 65 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dexamethasone, at least twice daily, on days 1-4 and 9-12. Patients undergo plasma exchange by cytocentrifugation or plasmafiltration over 2-3 hours in weeks 1 and 2 (7 treatments total; 4 of them in week 1). Patients then receive planned chemotherapy per local clinician on days 17-100. Chemotherapy may continue after 100 days at the discretion of the local clinician.
- Arm II: Patients receive dexamethasone and planned chemotherapy as in arm I. Quality of life is assessed at baseline, day 100, and 6 and 12 months.
After completion of study treatment, patients are followed at 6 and 12 months and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
- Being tested
- chemotherapy, dexamethasone, plasmapheresis
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, renal failure
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
dexamethasoneDrug
plasmapheresisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive and dialysis-independent at 100 days
Secondary outcomes (6)
Proportion of patients alive and dialysis-independent at 6 and 12 months
Overall survival
Glomerular filtration rate (calculated or measured) at 15 and 100 days and at 6 and 12 months
Change in serum free light chain levels between days 0 and 15
Response of myeloma to treatment at 100 days and at 6 and 12 months
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startMar 2003
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Investigators
- Gill Gaskin, MD, Study chair, Hammersmith Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416897
- Sponsor's protocol ID
- CDR0000523378
- Other IDs
- CRUK-MERIT, EU-20670, ISRCTN37161699
- Status last verified
- Jun 2007
- First submitted
- 27 Dec 2006
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Adjunctive Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Renal Failure [MERIT] MyEloma Renal Impairment Trial
- ClinicalTrials.gov ID
- NCT00416897
- Acronym / sponsor ID
- CDR0000523378
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, renal failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Dexamethasone is used to treat multiple myeloma. Drugs used in chemotherapy may stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Plasma exchange is a process in which certain cells are separated from the plasma in the blood by a machine and then only the cells are returned to the patient. Dexamethasone and plasma exchange may be an effective treatment for acute kidney failure caused by multiple myeloma. It is not yet known whether giving dexamethasone and chemotherapy together with plasma exchange is more effective than giving dexamethasone and chemotherapy alone in treating patients with multiple myeloma and acute kidney failure.
PURPOSE: This randomized phase III trial is studying dexamethasone, chemotherapy, and plasma exchange to see how well they work compared with dexamethasone and chemotherapy alone in treating patients with newly diagnosed multiple myeloma and acute kidney failure.
Detailed description
OBJECTIVES:
Primary
- Compare the effect of dexamethasone and cytotoxic chemotherapy with vs without plasma exchange on the likelihood of renal recovery (i.e., dialysis-independent at 100 days) in patients with newly diagnosed multiple myeloma and acute renal failure.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Determine the value of renal histology in predicting recovery of renal function in these patients.
- Determine the value of serum free light chain assay in determining disease response and renal function recovery in these patients.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to planned chemotherapy (vincristine and doxorubicin hydrochloride (VA) or VA-like chemotherapy vs thalidomide-containing chemotherapy vs alkylating agent vs other), frequency of chemotherapy courses (1-3 weekly vs 4 weekly), need for dialysis at randomization (yes vs no), and age (< 65 years vs ≥ 65 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dexamethasone, at least twice daily, on days 1-4 and 9-12. Patients undergo plasma exchange by cytocentrifugation or plasmafiltration over 2-3 hours in weeks 1 and 2 (7 treatments total; 4 of them in week 1). Patients then receive planned chemotherapy per local clinician on days 17-100. Chemotherapy may continue after 100 days at the discretion of the local clinician.
- Arm II: Patients receive dexamethasone and planned chemotherapy as in arm I. Quality of life is assessed at baseline, day 100, and 6 and 12 months.
After completion of study treatment, patients are followed at 6 and 12 months and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemotherapy | Drug | – |
| dexamethasone | Drug | – |
| plasmapheresis | Procedure or surgery | – |
Primary outcome
Proportion of patients alive and dialysis-independent at 100 days
6 secondary outcomes
Proportion of patients alive and dialysis-independent at 6 and 12 months
Overall survival
Glomerular filtration rate (calculated or measured) at 15 and 100 days and at 6 and 12 months
Change in serum free light chain levels between days 0 and 15
Response of myeloma to treatment at 100 days and at 6 and 12 months
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gill Gaskin, MD study chair
Hammersmith Hospitals NHS Trust
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chemotherapy, dexamethasone and plasmapheresis in people with Multiple Myeloma and Plasma Cell Neoplasm and Renal Failure, run by University of Glasgow at 39 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients alive and dialysis-independent at 100 days. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.