Status:
COMPLETED
Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure
Lead Sponsor:
University of Glasgow
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 exchan...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00416897
Start Date
March 1 2003
End Date
December 1 2008
Last Update
August 26 2013
Active Locations (39)
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1
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
2
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
3
Good Hope Hospital
Birmingham, England, United Kingdom, B75 7RR
4
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS