Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398515
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2006-11-09
Brief Title:
Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of CC-5013 Lenalidomide and CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This phase I trial is studying the side effects and best dose of temsirolimus when given together with lenalidomide in treating patients with previously treated multiple myeloma Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer Drugs used in chemotherapy such as temsirolimus work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Temsirolimus may also stop the growth of cancer cells by blocking some of the enzymes needed for their growth Giving lenalidomide together with temsirolimus may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of CCI-779 temsirolimus when given together with lenalidomide in patients with previously treated multiple myeloma
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine the clinical response of patients treated with this regimen III Determine the pharmacokinetics of this regimen IV Determine the pharmacodynamic effects of this regimen in these patients V Determine the effect of this regimen on immunological cellular and serological parameters and hematopoietic precursor cells
OUTLINE This is a dose-escalation study of CCI-779
Patients receive temsirolimus intravenously IV over 30 minutes on days 1 8 15 and 22 and oral lenalidomide once daily on days 1-21 Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity
Patients achieving at least a partial response after 12 courses may continue to receive CCI-779 and lenalidomide as above in the absence of disease progression Cohorts of 3 patients receive escalating doses of CCI-779 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Ten patients are treated at the MTD Patients undergo blood sample and bone marrow collection periodically during study treatment for pharmacokinetic and pharmacodynamic studies and to determine the immunomodulatory effects of CCI-779 and lenalidomide
I Determine the maximum tolerated dose of CCI-779 temsirolimus when given together with lenalidomide in patients with previously treated multiple myeloma
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine the clinical response of patients treated with this regimen III Determine the pharmacokinetics of this regimen IV Determine the pharmacodynamic effects of this regimen in these patients V Determine the effect of this regimen on immunological cellular and serological parameters and hematopoietic precursor cells
OUTLINE This is a dose-escalation study of CCI-779
Patients receive temsirolimus intravenously IV over 30 minutes on days 1 8 15 and 22 and oral lenalidomide once daily on days 1-21 Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity
Patients achieving at least a partial response after 12 courses may continue to receive CCI-779 and lenalidomide as above in the absence of disease progression Cohorts of 3 patients receive escalating doses of CCI-779 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Ten patients are treated at the MTD Patients undergo blood sample and bone marrow collection periodically during study treatment for pharmacokinetic and pharmacodynamic studies and to determine the immunomodulatory effects of CCI-779 and lenalidomide
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 |
|---|---|---|---|
| U01CA076576 | NIH | CTEP | httpsreporternihgovquickSearchU01CA076576 |
| NCI-2009-00151 | REGISTRY | None | None |
| OSU-2006C0040 | None | None | None |
| CDR0000514831 | None | None | None |
| OSU-05115 | None | None | None |
| 05115 | OTHER | None | None |
| 7314 | OTHER | None | None |