Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038090
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2002-05-28
Brief Title:
Thalidomide-Dexamethasone for Multiple Myeloma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Thalidomide-Dexamethasone for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Objective is to assess the activity of the combination of thalidomide and dexamethasone in patients with previously untreated multiple myeloma
Detailed Description:
This study will examine the potential efficacy of thalidomide-dexamethasone in the treatment of patients with previously untreated multiple myeloma
Thalidomide is supplied as 50 mg capsules to be taken by mouth
Thalidomide 200 mg daily each evening at bedtime increasing by 100-200 mg increments according to patient tolerability every 4 weeks
For elderly patients or those with poor performance status or comorbid conditions which may affect tolerance of the thalidomide-dexamethasone combination the initial dose may be reduced by 50-100 mg decrements and escalated weekly by 50-100 mg increments to tolerance For patients who experience significant toxicity grade 2 or are otherwise unable to tolerate this drug combination the dose will be reduced by 50-100 mg decrements For some patients with grade 2 toxicity it may be necessary to hold the thalidomide dose until improvement of the side effect with subsequent resumption of the dose after dose reduction as outlined above
Dexamethasone 20mgm2 each morning after breakfast on days 1-4 9-12 17-20 with a repeat cycle after a 1-2 week rest period In case of partial remission maintenance treatment with thalidomide alone will be continued for as long as remission is sustained at a dose free of side effects
For patients achieving CR consolidation with thalidomide-dexamethasone for 4-6 months followed by follow-up without maintenance treatment No maximum trial period is planned
At relapse patients may be reinitiated on the original thalidomide-pulse dexamethasone program and responding patients may be maintained on thalidomide alone CR or daily thalidomide and dexamethasone days 1-4 until relapse
Patients who experience significant toxicity grade 2 or more at any time during therapy will receive a lower dose after treatment is interrupted
In an attempt to avoid deep venous thrombosis all patients for whom anticoagulation is not contraindicated will be offered therapeutic anticoagulation INR 15-25 with coumadin or therapeutic doses of low molecular weight heparin
Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals
Thalidomide is supplied as 50 mg capsules to be taken by mouth
Thalidomide 200 mg daily each evening at bedtime increasing by 100-200 mg increments according to patient tolerability every 4 weeks
For elderly patients or those with poor performance status or comorbid conditions which may affect tolerance of the thalidomide-dexamethasone combination the initial dose may be reduced by 50-100 mg decrements and escalated weekly by 50-100 mg increments to tolerance For patients who experience significant toxicity grade 2 or are otherwise unable to tolerate this drug combination the dose will be reduced by 50-100 mg decrements For some patients with grade 2 toxicity it may be necessary to hold the thalidomide dose until improvement of the side effect with subsequent resumption of the dose after dose reduction as outlined above
Dexamethasone 20mgm2 each morning after breakfast on days 1-4 9-12 17-20 with a repeat cycle after a 1-2 week rest period In case of partial remission maintenance treatment with thalidomide alone will be continued for as long as remission is sustained at a dose free of side effects
For patients achieving CR consolidation with thalidomide-dexamethasone for 4-6 months followed by follow-up without maintenance treatment No maximum trial period is planned
At relapse patients may be reinitiated on the original thalidomide-pulse dexamethasone program and responding patients may be maintained on thalidomide alone CR or daily thalidomide and dexamethasone days 1-4 until relapse
Patients who experience significant toxicity grade 2 or more at any time during therapy will receive a lower dose after treatment is interrupted
In an attempt to avoid deep venous thrombosis all patients for whom anticoagulation is not contraindicated will be offered therapeutic anticoagulation INR 15-25 with coumadin or therapeutic doses of low molecular weight heparin
Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None