Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477815
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2007-05-23
Brief Title:
Rituximab Yttrium Y 90 Ibritumomab Tiuxetan Melphalan and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Trial of Zevalin Radioimmunotherapy With High-Dose Melphalan and Stem Cell Transplant for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2018-05
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 Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Radiolabeled monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan can find cancer cells and carry cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as melphalan work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing A peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by chemotherapy Giving monoclonal antibody therapy together with chemotherapy and autologous peripheral stem cell transplant may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab melphalan and autologous peripheral stem cell transplant in treating patients with previously treated multiple myeloma
PURPOSE This phase I trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab melphalan and autologous peripheral stem cell transplant in treating patients with previously treated multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Determine the safety of rituximab yttrium Y 90 ibritumomab tiuxetan high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with previously treated multiple myeloma
Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonotypic B-cells at baseline and at B-cell recovery in these patients
Secondary
Determine the response rate and progression factors time to progression progression-free survival and duration of response in patients treated with this regimen
Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonal plasma cells in the blood and marrow prior to high-dose melphalan
OUTLINE This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
Patients receive rituximab IV followed by a dosimetry dose of indium In 111 ibritumomab tiuxetan IV over 10 minutes on day -22 Patients with acceptable biodistribution receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14 high-dose melphalan IV over 1 hour on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation on day 0 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 0 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of yttrium Y 90 ibritumomab tiuxetan 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
Bone marrow blood and urine samples are collected at baseline and then periodically during study for biomarker correlative studies
After completion of study treatment patients are followed every 3 months for 5 years
Primary
Determine the safety of rituximab yttrium Y 90 ibritumomab tiuxetan high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with previously treated multiple myeloma
Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonotypic B-cells at baseline and at B-cell recovery in these patients
Secondary
Determine the response rate and progression factors time to progression progression-free survival and duration of response in patients treated with this regimen
Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonal plasma cells in the blood and marrow prior to high-dose melphalan
OUTLINE This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
Patients receive rituximab IV followed by a dosimetry dose of indium In 111 ibritumomab tiuxetan IV over 10 minutes on day -22 Patients with acceptable biodistribution receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14 high-dose melphalan IV over 1 hour on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation on day 0 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 0 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of yttrium Y 90 ibritumomab tiuxetan 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
Bone marrow blood and urine samples are collected at baseline and then periodically during study for biomarker correlative studies
After completion of study treatment patients are followed every 3 months for 5 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 |
|---|---|---|---|
| 106-P148 | OTHER | Biogen IDEC protocol | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC048A | OTHER | None | None |
| 449-05 | OTHER | None | None |
| NCI-2009-01399 | REGISTRY | None | None |
| 021-03-ZEV | OTHER | None | None |