Recurrent Plasma Cell Myeloma Clinical Trial
Official title:
Phase I/II 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
This phase I/II 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.
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 (i.e. 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 12/17/2009 and reopened 10/13/2011): Patients
receive MV-NIS intravenously (IV) over 1 hour on day 1.
STAGE 2 (MV-NIS AND CYCLOPHOSPHAMIDE, temporarily closed to accrual on 10/13/11): 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Terminated |
NCT04956302 -
Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
|
Phase 1 | |
Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
Completed |
NCT01689987 -
Hydroxychloroquine, Cyclophosphamide, Dexamethasone, and Sirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
Completed |
NCT02506959 -
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
|
Phase 2 | |
Active, not recruiting |
NCT03457142 -
Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy
|
Phase 2 | |
Recruiting |
NCT03246906 -
Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
|
Phase 2 | |
Withdrawn |
NCT03328936 -
Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant
|
Phase 2 | |
Active, not recruiting |
NCT02765854 -
Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement
|
Phase 2 | |
Recruiting |
NCT05514990 -
Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
|
Phase 1/Phase 2 | |
Completed |
NCT01989598 -
Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
Completed |
NCT03605719 -
Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma
|
Phase 1 | |
Completed |
NCT01903811 -
S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma
|
Phase 2 | |
Recruiting |
NCT05391750 -
Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma
|
Phase 1 | |
Completed |
NCT00789776 -
Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02593123 -
Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis
|
Phase 2 | |
Terminated |
NCT04407442 -
Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab
|
Phase 2 | |
Completed |
NCT03338972 -
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
Recruiting |
NCT04508790 -
Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
Recruiting |
NCT05363111 -
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
|
Phase 1 |