Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006219
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2000-09-11
Brief Title:
Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
Status:
COMPLETED
Status Verified Date:
2011-08
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma
PURPOSE Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma
PURPOSE Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma
Detailed Description:
OBJECTIVES
Determine whether dehydroepiandrosterone DHEA or clarithromycin causes a significant reduction in bone marrow plasmacytosis serum andor urine M protein or Bence Jones protein and surrogate endpoint biomarkers in patients with monoclonal gammopathy of undetermined or borderline significance
Determine whether differences in interleukin-1-beta IL-1-beta expression and IL-1-beta dependent biomarkers adhesion molecule expression and serum interleukin-6 levels are useful surrogate endpoint biomarkers in these patients
Determine whether differences in ploidy proliferative index nuclear pleomorphism index circulating monoclonal plasma cells Th1Th2 ratios serum s-interleukin-6R SIL-6R levels interleukin-6 and SIL-6R expression or plasma cell apoptosis assay are useful surrogate endpoint biomarkers in these patients
Determine the effects of these treatment regimens on the quality of life of these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to disease monoclonal gammopathy of undetermined significance vs monoclonal gammopathy of borderline significance and monoclonal protein abnormality IgG vs IgA Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral dehydroepiandrosterone DHEA once daily
Arm II Patients receive oral clarithromycin once or twice daily
Arm III Patients receive oral placebo once daily
Arm IV Patients receive oral placebo twice daily Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 6 months 12 months and then at disease progression
Patients are followed every 3 months for 1 year and then every 6 months for 15 years
PROJECTED ACCRUAL A total of 75 patients 25 per treatment arms I and II and 25 between arms III and IV will be accrued for this study within 25 years
Determine whether dehydroepiandrosterone DHEA or clarithromycin causes a significant reduction in bone marrow plasmacytosis serum andor urine M protein or Bence Jones protein and surrogate endpoint biomarkers in patients with monoclonal gammopathy of undetermined or borderline significance
Determine whether differences in interleukin-1-beta IL-1-beta expression and IL-1-beta dependent biomarkers adhesion molecule expression and serum interleukin-6 levels are useful surrogate endpoint biomarkers in these patients
Determine whether differences in ploidy proliferative index nuclear pleomorphism index circulating monoclonal plasma cells Th1Th2 ratios serum s-interleukin-6R SIL-6R levels interleukin-6 and SIL-6R expression or plasma cell apoptosis assay are useful surrogate endpoint biomarkers in these patients
Determine the effects of these treatment regimens on the quality of life of these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to disease monoclonal gammopathy of undetermined significance vs monoclonal gammopathy of borderline significance and monoclonal protein abnormality IgG vs IgA Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral dehydroepiandrosterone DHEA once daily
Arm II Patients receive oral clarithromycin once or twice daily
Arm III Patients receive oral placebo once daily
Arm IV Patients receive oral placebo twice daily Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 6 months 12 months and then at disease progression
Patients are followed every 3 months for 1 year and then every 6 months for 15 years
PROJECTED ACCRUAL A total of 75 patients 25 per treatment arms I and II and 25 between arms III and IV will be accrued for this study within 25 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 979202 | OTHER | Mayo Clinic Cancer Center | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |