Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477750
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2007-05-23
Brief Title:
Melphalan Prednisone and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase III Trial of Melphalan Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant
Status:
COMPLETED
Status Verified Date:
2015-10
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:
RATIONALE Drugs used in chemotherapy such as melphalan prednisone and lenalidomide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma
PURPOSE This phase III trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of melphalan and lenalidomide in combination with prednisone in patients with newly diagnosed multiple myeloma
Determine the response rate in patients treated with this regimen Secondary
Determine the toxicity of this regimen in these patients OUTLINE This is a dose-escalation study of melphalan and lenalidomide followed by a phase II study
Phase I Patients receive oral melphalan and oral prednisone daily on days 1-4 Patients also receive oral lenalidomide daily on days 1-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oral melphalan and oral lenalidomide as in phase I at the MTD Patients also receive oral prednisone as in phase I Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years
Primary
Determine the maximum tolerated dose of melphalan and lenalidomide in combination with prednisone in patients with newly diagnosed multiple myeloma
Determine the response rate in patients treated with this regimen Secondary
Determine the toxicity of this regimen in these patients OUTLINE This is a dose-escalation study of melphalan and lenalidomide followed by a phase II study
Phase I Patients receive oral melphalan and oral prednisone daily on days 1-4 Patients also receive oral lenalidomide daily on days 1-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oral melphalan and oral lenalidomide as in phase I at the MTD Patients also receive oral prednisone as in phase I Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 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 |
|---|---|---|---|
| RV-MM-PI-025 | OTHER | Celgene protocol | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC038A | OTHER | None | None |
| 2387-04 | OTHER | None | None |