Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038233
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2002-05-29
Brief Title:
Thalidomide for Multiple Myeloma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Thalidomide 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:
The objective of this protocol is to assess therapeutic activity of thalidomide in previously untreated patients with asymptomatic multiple myeloma
Detailed Description:
This study attempts to examine the potential efficacy of thalidomide in the treatment of patients with previously untreated multiple myeloma The trial focuses on patients with asymptomatic and indolent disease who do not require immediate chemotherapy We intend to treat asymptomatic patients with an initial dose of 200 mg each evening increasing to a maximum of 800 mg
Thalidomide is supplied as 50 mg capsules to be taken by mouth The initial dose will be 200 mg at bedtime daily for 14 days days 1-14 followed by an increase to 400 mg daily for 14 days days 15-28 600 mg daily for 14 days days 29-42 up to a maximum 800 mg days 43-completion daily provided there are no side effects
Patients who experience significant toxicity grade 2 or more at any time during therapy will receive a lower dose after treatment is interrupted for at least 2 days
Once a maximum tolerated dose has been reached free of side effects that dose will be continued for a total of 3 months from institution of therapy before definition of response or resistance Only patients who have received at least 200 mgd for at least 2 months will be considered evaluable for response For patients in remission treatment will be continued at the maximum dose free of side effects until relapse Selected patients 55 years of age who achieve remission may be eligible for stem cell transplant SCT in which case thalidomide will be discontinued prior to SCT
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 The initial dose will be 200 mg at bedtime daily for 14 days days 1-14 followed by an increase to 400 mg daily for 14 days days 15-28 600 mg daily for 14 days days 29-42 up to a maximum 800 mg days 43-completion daily provided there are no side effects
Patients who experience significant toxicity grade 2 or more at any time during therapy will receive a lower dose after treatment is interrupted for at least 2 days
Once a maximum tolerated dose has been reached free of side effects that dose will be continued for a total of 3 months from institution of therapy before definition of response or resistance Only patients who have received at least 200 mgd for at least 2 months will be considered evaluable for response For patients in remission treatment will be continued at the maximum dose free of side effects until relapse Selected patients 55 years of age who achieve remission may be eligible for stem cell transplant SCT in which case thalidomide will be discontinued prior to SCT
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