Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014339
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-04-10
Brief Title:
Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
Sponsor:
Medsearch
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Placebo-Controlled Multicenter Study to Demonstrate the Effectiveness and Safety of the Combination Enzyme Tablet Wobe-Mugos E as Adjuvant Therapy to Standard of Care Treatment in Patients With Stages II or III Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Enzyme products such as Wobe-Mugos E may help to reduce the side effects of multiple myeloma therapy It is not yet known if chemotherapy is more effective with or without Wobe-Mugos E in treating multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with or without Wobe-Mugos E in treating patients who have stage II or stage III multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with or without Wobe-Mugos E in treating patients who have stage II or stage III multiple myeloma
Detailed Description:
OBJECTIVES I Compare the long-term survival of patients with chemotherapy-naive stage II or III multiple myeloma treated with standard melphalan and prednisone with or without adjuvant Wobe-Mugos E II Compare the effect of these two regimens on the reduction of the side effects from chemotherapy in these patients using 2 quality of life questionnaires III Compare the effect of these two regimens on tumor response rate and new metastasis development in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral melphalan and oral prednisone on days 1-4 Patients also receive adjuvant enzyme therapy with oral Wobe-Mugos E 3 times daily beginning prior to or on day 1 of the first course of chemotherapy Arm II Patients receive melphalan and prednisone as in arm I Patients also receive an oral placebo 3 times daily as in arm I Treatment continues for a minimum of 12 months to up to 4 years in the absence of unacceptable toxicity Patients continue on melphalan and prednisone on a 4-week course until achieving maximum response or plateau phase and then receive 2 additional courses of therapy Quality of life is assessed at baseline at 1 3 and 6 months and every 6 months for up to 4 years during study and then at end of study Patients are followed for survival for 1 month after completing the study and all patients receive the enzyme product
PROJECTED ACCRUAL A total of 250 patients 125 per treatment arm will be accrued for this study within 15 years
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive oral melphalan and oral prednisone on days 1-4 Patients also receive adjuvant enzyme therapy with oral Wobe-Mugos E 3 times daily beginning prior to or on day 1 of the first course of chemotherapy Arm II Patients receive melphalan and prednisone as in arm I Patients also receive an oral placebo 3 times daily as in arm I Treatment continues for a minimum of 12 months to up to 4 years in the absence of unacceptable toxicity Patients continue on melphalan and prednisone on a 4-week course until achieving maximum response or plateau phase and then receive 2 additional courses of therapy Quality of life is assessed at baseline at 1 3 and 6 months and every 6 months for up to 4 years during study and then at end of study Patients are followed for survival for 1 month after completing the study and all patients receive the enzyme product
PROJECTED ACCRUAL A total of 250 patients 125 per treatment arm will be accrued for this study within 15 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 |
|---|---|---|---|
| MUCOS-MU-699-501 | None | None | None |
| MEDSEARCH-MU-699-501 | None | None | None |