Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003153
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Salvage Cellular Immunotherapy for Patients With Persistent or Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation From an HLA-Matched Sibling Donor
Status:
COMPLETED
Status Verified Date:
2023-06
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 White blood cells from donors may be able to kill cancer cells in patients with multiple myeloma that has recurred following bone marrow transplantation
PURPOSE This phase II trial is studying how well giving donor white blood cells works in treating patients with recurrent multiple myeloma who have undergone bone marrow transplantation
PURPOSE This phase II trial is studying how well giving donor white blood cells works in treating patients with recurrent multiple myeloma who have undergone bone marrow transplantation
Detailed Description:
OBJECTIVES
Assess the response rate of patients with recurrent multiple myeloma after an allogeneic marrow transplant from a genotypically HLA identical sibling donor treated with donor lymphocyte infusions as salvage therapy
Evaluate the safety and toxicity of this treatment when used as salvage therapy in these patients
OUTLINE Patients receive initial cell dose of donor lymphocytes CD3 cells IV over 15-30 minutes Patients with rapidly progressive disease may skip the initial cell dose and proceed directly to dose escalation to receive CD3 cells at a higher cell dose Patients who achieve complete response to the initial treatment may receive up to 2 additional courses of escalating doses of CD3 cells 8-12 weeks apart in the absence of unacceptable toxicity Patients are evaluated at 4 and 8 weeks after each infusion Patients with disease progression at 8 weeks are retreated at that time Patients who achieve partial response or stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated
Patients are followed every 2 weeks for 3 months once a month for 9 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 22 patients will be accrued for this study within 2 years
Assess the response rate of patients with recurrent multiple myeloma after an allogeneic marrow transplant from a genotypically HLA identical sibling donor treated with donor lymphocyte infusions as salvage therapy
Evaluate the safety and toxicity of this treatment when used as salvage therapy in these patients
OUTLINE Patients receive initial cell dose of donor lymphocytes CD3 cells IV over 15-30 minutes Patients with rapidly progressive disease may skip the initial cell dose and proceed directly to dose escalation to receive CD3 cells at a higher cell dose Patients who achieve complete response to the initial treatment may receive up to 2 additional courses of escalating doses of CD3 cells 8-12 weeks apart in the absence of unacceptable toxicity Patients are evaluated at 4 and 8 weeks after each infusion Patients with disease progression at 8 weeks are retreated at that time Patients who achieve partial response or stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated
Patients are followed every 2 weeks for 3 months once a month for 9 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 22 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E1A97 | None | None | None |