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

NCT00416897 | Completed Phase 3

• 4 other identifiers: CDR0000523378CRUK-MERITEU-20670ISRCTN37161699
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 39

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm; Renal Failure

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; renal failure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

chemotherapy DRUG

dexamethasone DRUG

plasmapheresis PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (39)

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Good Hope Hospital

Birmingham, England, B75 7RR, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Bradford Royal Infirmary

Bradford, England, BD9 6RJ, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

St. Helier Hospital

Carshalton, England, SM5 1AA, United Kingdom

Location

Saint Richards Hospital

Chichester, England, P019 4SE, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Harrogate District Hospital

Harrogate, England, HG2 7SX, United Kingdom

Location

Wycombe General Hospital

High Wycombe, England, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester General Hospital

Leicester, England, LE5 4PW, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. Georges, University of London

London, England, SW17 ORE, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 7LJ, United Kingdom

Location

Hope Hospital

Salford, England, M6 8HD, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, England, SR4 7TP, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Monklands General Hospital

Airdrie, Scotland, ML6 0JF, United Kingdom

Location

Dumfries & Galloway Royal Infirmary

Dumfries, Scotland, DG1 4AP, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Morriston Hospital NHS Trust

West Glamorgen, Scotland, SA6 6NL, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, Wales, LL13 7TD, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Renal Insufficiency

Interventions

Drug Therapy; Dexamethasone; Plasmapheresis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Gill Gaskin, MD

  Hammersmith Hospitals NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: March 1, 2003
• Study Completion: December 1, 2008
• Last Updated: August 26, 2013

Record last verified: 2007-06

Locations

GB (39)