Back to resultsDexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Thalidomide, Dexamethasone
Eligibility Criteria
Inclusion Criteria: All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with hypoproliferative/low risk relapse following at least one autologous transplant. Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter. Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination. Patients must have a SWOG performance status of 0-2. Patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl. Patients must be off chemotherapy (including steroids) and local radiotherapy for > or equal 3 weeks prior to entering the study. Exclusion Criteria: No other concurrent therapy for myeloma is permitted while on protocol. There must be no evidence of active infection requiring IV antibiotics.
Sites / Locations
- University of Arkansas for Medical Sciences/MIRT
Outcomes
Primary Outcome Measures
To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.
Secondary Outcome Measures
To evaluate the quantitative and qualitative toxicities associated with the regimens.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00083902
Brief Title
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
Official Title
UARK 98-025, A Randomized Phase II Trial of Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy for Low-Risk Post Transplantation Relapse in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Arkansas
4. Oversight
5. Study Description
Brief Summary
The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a standard regimen of dexamethasone with or without thalidomide and also find out what kind of side effects patients will experience.
Detailed Description
Maintenance
Dexamethasone
Patients will receive 40 mg dexamethasone days 1-4 only, every 3-4 weeks. Response will be assessed at least every 3 months while on maintenance therapy. Appropriate H2 blocker and antibiotics will also be given.
Thalidomide
Thalidomide will continue at a dose of 400 mg daily, or at the dose that was reduced and judged to be well tolerated in induction therapy. Thalidomide will be given as an oral, once daily dose at bedtime. Those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Thalidomide, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.
Secondary Outcome Measure Information:
Title
To evaluate the quantitative and qualitative toxicities associated with the regimens.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with hypoproliferative/low risk relapse following at least one autologous transplant.
Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.
Patients must have a SWOG performance status of 0-2.
Patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl.
Patients must be off chemotherapy (including steroids) and local radiotherapy for > or equal 3 weeks prior to entering the study.
Exclusion Criteria:
No other concurrent therapy for myeloma is permitted while on protocol.
There must be no evidence of active infection requiring IV antibiotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Zangari, M.D.
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/MIRT
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Links:
URL
http://myeloma.uams.edu
Description
Myeloma Institute for Research & Therapy website
Learn more about this trial
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
We'll reach out to this number within 24 hrs