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Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure

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ClinicalTrials.gov Identifier: NCT00416897
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Renal Failure Drug: chemotherapy Drug: dexamethasone Procedure: plasmapheresis Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2003
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients alive and dialysis-independent at 100 days

Secondary Outcome Measures :
  1. Proportion of patients alive and dialysis-independent at 6 and 12 months
  2. Overall survival
  3. Glomerular filtration rate (calculated or measured) at 15 and 100 days and at 6 and 12 months
  4. Change in serum free light chain levels between days 0 and 15
  5. Response of myeloma to treatment at 100 days and at 6 and 12 months
  6. Quality of life

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416897


Locations
United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Good Hope Hospital
Birmingham, England, United Kingdom, B75 7RR
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Bradford Royal Infirmary
Bradford, England, United Kingdom, BD9 6RJ
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
St. Helier Hospital
Carshalton, England, United Kingdom, SM5 1AA
Saint Richards Hospital
Chichester, England, United Kingdom, P019 4SE
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Harrogate District Hospital
Harrogate, England, United Kingdom, HG2 7SX
Wycombe General Hospital
High Wycombe, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester General Hospital
Leicester, England, United Kingdom, LE5 4PW
Aintree University Hospital
Liverpool, England, United Kingdom, L9 7AL
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
St. Georges, University of London
London, England, United Kingdom, SW17 ORE
Hammersmith Hospital
London, England, United Kingdom, W12 OHS
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 7LJ
Hope Hospital
Salford, England, United Kingdom, M6 8HD
Staffordshire General Hospital
Stafford, England, United Kingdom, ST16 3SA
Sunderland Royal Hospital
Sunderland, England, United Kingdom, SR4 7TP
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Cancer Care Centre at York Hospital
York, England, United Kingdom, Y031 8HE
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom, BT9 7BL
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Monklands General Hospital
Airdrie, Scotland, United Kingdom, ML6 0JF
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, United Kingdom, DG1 4AP
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
Morriston Hospital NHS Trust
West Glamorgen, Scotland, United Kingdom, SA6 6NL
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom, LL13 7TD
Sponsors and Collaborators
University of Glasgow
Investigators
Study Chair: Gill Gaskin, MD Hammersmith Hospitals NHS Trust
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00416897     History of Changes
Other Study ID Numbers: CDR0000523378
CRUK-MERIT
EU-20670
ISRCTN37161699
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
renal failure

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Kidney Diseases
Urologic Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists