Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416897
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2006-12-27
Brief Title:
Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure
Sponsor:
University of Glasgow
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
Primary
Compare the effect of dexamethasone and cytotoxic chemotherapy with vs without plasma exchange on the likelihood of renal recovery ie 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN37161699 | None | None | None |
| CRUK-MERIT | None | None | None |
| EU-20670 | None | None | None |