Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046852
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2002-10-03
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
High-Dose Therapy and Autologous Blood Stem Cell Transplantation ASCT Followed by Post-Transplant Immunotherapy With Costimulated Autologous T-Cells in Conjunction With Pneumococcal Conjugate Vaccine Immunization for Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2019-10
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 use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with autologous peripheral stem cell transplantation and immunotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Randomized phase III trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation followed by immunotherapy in treating patients who have multiple myeloma
PURPOSE Randomized phase III trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation followed by immunotherapy in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES
Determine the feasibility of expanding ex vivo autologous T cells and infusing these cells after high-dose chemotherapy and autologous peripheral blood stem cell rescue in patients with multiple myeloma
Determine the response rate and progression-free survival of patients who receive anti-CD3anti-CD28 expanded autologous T cells on either day 14 or day 100 post-transplantation
Compare response and survival rates of these patients to historical controls
Determine the optimal schedule for pneumococcal conjugate vaccine PCV to induce an anti-pneumococcal immune response post-transplantation in these patients
Determine whether vaccine education of antigen-presenting cells APCs in the stem cell graft results in an earlier andor enhanced immune response than with a graft containing non-educated APCs in these patients
Determine whether an infusion of T cells presensitized to the PCV and expanded ex vivo contributes to the anti-pneumococcal immune response in these patients
OUTLINE This is a randomized multicenter study
Patients receive cyclophosphamide IV over 12 hours on day 1 and filgrastim G-CSF subcutaneously SC daily beginning on day 2 Patients undergo leukapheresis to collect mononuclear cells for autologous T cells ATCs and peripheral blood stem cells PBSCs ATCs are generated by ex vivo expansion for 8-14 days and selection for CD3CD28 cells
Patients then receive high-dose therapy comprising carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1 or melphalan IV alone on days -2 and -1 or day -1 only Autologous PBSCs are reinfused on day 0 Patients also receive G-CSF SC beginning on day 1 and continuing until blood counts recover
Patients who choose to receive pneumococcal conjugate vaccine PCV are randomized to 1 of 4 treatment arms
Arm I Patients receive PCV intramuscularly prior to transplantation 10-14 days before lymphocyte collection and post-transplantation 1 and 3 months plus costimulated ATCs IV over 20-60 minutes around day 12-14 post-transplantation
Arm II Patients receive PCV as in arm I but receive ATCs around day 100 post-transplantation
Arm III Patients receive PCV post-transplantation only at 1 and 3 months plus ATCs as in arm I
Arm IV Patients receive PCV as in arm III and ATCs as in arm II Patients who choose not to receive the PCV receive ATCs on about day 12-14 after PBSC transplantation
All patients are offered standard pneumococcal polysaccharide vaccine at 12 months
Patients are followed twice weekly until day 60 weekly for 4 months monthly for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 16-46 patients will be accrued for this study within 14 months
Determine the feasibility of expanding ex vivo autologous T cells and infusing these cells after high-dose chemotherapy and autologous peripheral blood stem cell rescue in patients with multiple myeloma
Determine the response rate and progression-free survival of patients who receive anti-CD3anti-CD28 expanded autologous T cells on either day 14 or day 100 post-transplantation
Compare response and survival rates of these patients to historical controls
Determine the optimal schedule for pneumococcal conjugate vaccine PCV to induce an anti-pneumococcal immune response post-transplantation in these patients
Determine whether vaccine education of antigen-presenting cells APCs in the stem cell graft results in an earlier andor enhanced immune response than with a graft containing non-educated APCs in these patients
Determine whether an infusion of T cells presensitized to the PCV and expanded ex vivo contributes to the anti-pneumococcal immune response in these patients
OUTLINE This is a randomized multicenter study
Patients receive cyclophosphamide IV over 12 hours on day 1 and filgrastim G-CSF subcutaneously SC daily beginning on day 2 Patients undergo leukapheresis to collect mononuclear cells for autologous T cells ATCs and peripheral blood stem cells PBSCs ATCs are generated by ex vivo expansion for 8-14 days and selection for CD3CD28 cells
Patients then receive high-dose therapy comprising carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1 or melphalan IV alone on days -2 and -1 or day -1 only Autologous PBSCs are reinfused on day 0 Patients also receive G-CSF SC beginning on day 1 and continuing until blood counts recover
Patients who choose to receive pneumococcal conjugate vaccine PCV are randomized to 1 of 4 treatment arms
Arm I Patients receive PCV intramuscularly prior to transplantation 10-14 days before lymphocyte collection and post-transplantation 1 and 3 months plus costimulated ATCs IV over 20-60 minutes around day 12-14 post-transplantation
Arm II Patients receive PCV as in arm I but receive ATCs around day 100 post-transplantation
Arm III Patients receive PCV post-transplantation only at 1 and 3 months plus ATCs as in arm I
Arm IV Patients receive PCV as in arm III and ATCs as in arm II Patients who choose not to receive the PCV receive ATCs on about day 12-14 after PBSC transplantation
All patients are offered standard pneumococcal polysaccharide vaccine at 12 months
Patients are followed twice weekly until day 60 weekly for 4 months monthly for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 16-46 patients will be accrued for this study within 14 months
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 |
|---|---|---|---|
| NCI-V02-1709 | None | None | None |
| MSGCC-0065 | None | None | None |
| UPCC-6401 | None | None | None |