Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450814
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2007-03-20
Brief Title:
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase III Trial of Systemic Administration of Edmonston Strain of Measles Virus Genetically Engineered to Express NIS With or Without Cyclophosphamide in Patients With Recurrent or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2019-01
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 III trial studies the side effects and best dose of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients with multiple myeloma that has come back recurrent or has not responded to previous treatment refractory Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving vaccine therapy together with cyclophosphamide may be a better treatment for multiple myeloma
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of oncolytic measles virus encoding thyroidal sodium iodide symporter MV-NIS when administered with or without cyclophosphamide in patients with relapsed or refractory multiple myeloma Phase I II To evaluate the confirmed response rate of MV-NIS alone in patients with relapsed or refractory multiple myeloma who have exhausted all therapeutic options Phase II Cohort A III To evaluate the confirmed response rate of MV-NIS alone in patients who are relapsing from very good partial response VGPR or complete response CR and have not received myeloma directed therapy for at least 12 weeks Phase II Cohort B
SECONDARY OBJECTIVES
I To determine the safety and toxicity of the intravenous administration of an Edmonston vaccine strain measles virus engineered to express the thyroidal sodium iodide symporter MV-NIS when administered with or without cyclophosphamide in patients with relapsed or refractory multiple myeloma Phase I II To evaluate the confirmed response rate of MV-NIS in patients with relapsed or refractory multiple myeloma Phase I III To further evaluate the adverse event profile of MV-NIS in patients with relapsed or refractory multiple myeloma Phase II IV To evaluate overall survival failure-free survival and progression-free survival Phase II
TERTIARY OBJECTIVES
I To determine the time course of viral gene expression and virus elimination and the biodistribution of virally infected cells at various times points after infection with MV-NIS when administered with or without cyclophosphamide using 99m-technetium Tc gamma camera imaging Phase I and II II To assess virus replication viremia viral shedding in urine and respiratory secretions and virus persistence after systemic administration of MV-NIS when administered with or without cyclophosphamide Phase I and II III To monitor humoral responses to the injected virus Phase I and II IV To explore the anti-myeloma efficacy ie clinical response rate time to progression progression free survival duration of response of the virus using standard myeloma response criteria as well as immunoglobulin free light chain measurements Phase I and II
OUTLINE This is a phase I dose-escalation study of MV-NIS followed by a phase II study Patients are assigned to 1 of 2 treatment arms Stage 1 or Stage 2 in phase I and assigned to Stage 1 in phase II
STAGE 1 MV-NIS ALONE closed to accrual on 12172009 and reopened 10132011 Patients receive MV-NIS intravenously IV over 1 hour on day 1
STAGE 2 MV-NIS AND CYCLOPHOSPHAMIDE temporarily closed to accrual on 101311 Patients receive cyclophosphamide IV over 30 minutes and then MV-NIS IV over 1 hour 2 days later
After completion of study treatment patients are followed up at 6 weeks 12 weeks and then every 3 months for 1 year
I To determine the maximum tolerated dose MTD of oncolytic measles virus encoding thyroidal sodium iodide symporter MV-NIS when administered with or without cyclophosphamide in patients with relapsed or refractory multiple myeloma Phase I II To evaluate the confirmed response rate of MV-NIS alone in patients with relapsed or refractory multiple myeloma who have exhausted all therapeutic options Phase II Cohort A III To evaluate the confirmed response rate of MV-NIS alone in patients who are relapsing from very good partial response VGPR or complete response CR and have not received myeloma directed therapy for at least 12 weeks Phase II Cohort B
SECONDARY OBJECTIVES
I To determine the safety and toxicity of the intravenous administration of an Edmonston vaccine strain measles virus engineered to express the thyroidal sodium iodide symporter MV-NIS when administered with or without cyclophosphamide in patients with relapsed or refractory multiple myeloma Phase I II To evaluate the confirmed response rate of MV-NIS in patients with relapsed or refractory multiple myeloma Phase I III To further evaluate the adverse event profile of MV-NIS in patients with relapsed or refractory multiple myeloma Phase II IV To evaluate overall survival failure-free survival and progression-free survival Phase II
TERTIARY OBJECTIVES
I To determine the time course of viral gene expression and virus elimination and the biodistribution of virally infected cells at various times points after infection with MV-NIS when administered with or without cyclophosphamide using 99m-technetium Tc gamma camera imaging Phase I and II II To assess virus replication viremia viral shedding in urine and respiratory secretions and virus persistence after systemic administration of MV-NIS when administered with or without cyclophosphamide Phase I and II III To monitor humoral responses to the injected virus Phase I and II IV To explore the anti-myeloma efficacy ie clinical response rate time to progression progression free survival duration of response of the virus using standard myeloma response criteria as well as immunoglobulin free light chain measurements Phase I and II
OUTLINE This is a phase I dose-escalation study of MV-NIS followed by a phase II study Patients are assigned to 1 of 2 treatment arms Stage 1 or Stage 2 in phase I and assigned to Stage 1 in phase II
STAGE 1 MV-NIS ALONE closed to accrual on 12172009 and reopened 10132011 Patients receive MV-NIS intravenously IV over 1 hour on day 1
STAGE 2 MV-NIS AND CYCLOPHOSPHAMIDE temporarily closed to accrual on 101311 Patients receive cyclophosphamide IV over 30 minutes and then MV-NIS IV over 1 hour 2 days later
After completion of study treatment patients are followed up at 6 weeks 12 weeks and then every 3 months for 1 year
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 |
|---|---|---|---|
| R01CA168719 | NIH | Mayo Clinic | httpsreporternihgovquickSearchR01CA168719 |
| NCI-2009-01194 | REGISTRY | None | None |
| MC038C | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| R01CA125614 | NIH | None | None |