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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

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.

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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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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
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Sponsors and Collaborators
University of Glasgow
Investigators
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Study Chair: Gill Gaskin, MD Hammersmith Hospitals NHS Trust
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ClinicalTrials.gov Identifier: NCT00416897    
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:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Renal Insufficiency
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
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents