Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478075
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
2007-05-23
Brief Title:
Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase III Study of 153 Sm EDTMP Quadramet and PS-341 Velcade in Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-05
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 Radioactive drugs such as samarium Sm 153 lexidronam pentasodium may carry radiation directly to cancer cells and not harm normal cells Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer Bortezomib may also make cancer cells more sensitive to radiation therapy Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in treating patients with relapsed or refractory multiple myeloma
PURPOSE This phase III trial is studying the side effects and best dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium in patients with recurrent or refractory multiple myeloma Phase I
Determine the safety and tolerability of this regimen in these patients Phase II
Determine the hematologic response rate in patients treated with this regimen Phase II
Secondary
Determine the rate of serum immunoglobulin light chain reduction in patients treated with this regimen
Assess the in vivo toxicity of this regimen to the progenitor cells by measuring complete blood cell count and micronucleated reticulocyte count in these patients
OUTLINE This is a phase I pilot open-label dose-escalation study of bortezomib followed by a phase II study
Phase I Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1 and bortezomib IV over 3-5 seconds on days 2 and 5
Cohorts of 3-6 patients receive escalating doses of bortezomib 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 samarium Sm 153 lexidronam pentasodium as in phase I and bortezomib at the MTD determined in phase I
Patients undergo blood sample collection at baseline and then on days 1-6 for correlative studies Samples are analyzed for micronucleated reticulocyte count and immunoglobulin free light chain ratio to determine the early effects of treatment
After completion of study treatment patients are followed weekly for 7 weeks monthly for 3 months and then every 3 months for a total of 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium in patients with recurrent or refractory multiple myeloma Phase I
Determine the safety and tolerability of this regimen in these patients Phase II
Determine the hematologic response rate in patients treated with this regimen Phase II
Secondary
Determine the rate of serum immunoglobulin light chain reduction in patients treated with this regimen
Assess the in vivo toxicity of this regimen to the progenitor cells by measuring complete blood cell count and micronucleated reticulocyte count in these patients
OUTLINE This is a phase I pilot open-label dose-escalation study of bortezomib followed by a phase II study
Phase I Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1 and bortezomib IV over 3-5 seconds on days 2 and 5
Cohorts of 3-6 patients receive escalating doses of bortezomib 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 samarium Sm 153 lexidronam pentasodium as in phase I and bortezomib at the MTD determined in phase I
Patients undergo blood sample collection at baseline and then on days 1-6 for correlative studies Samples are analyzed for micronucleated reticulocyte count and immunoglobulin free light chain ratio to determine the early effects of treatment
After completion of study treatment patients are followed weekly for 7 weeks monthly for 3 months and then every 3 months for a total of 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| 1586-05 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC0585 | OTHER | None | None |