18 and older, any sex, with Recurrent Plasma Cell Myeloma or Refractory Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)Primary· 6 weeks
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
Group
Value
95% CI
Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
0
Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
0
Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
0
Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
0
Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
0
Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
1
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
0
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
0
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
0
Maximum Tolerated Dose (MTD) (Phase I)Primary· 6 weeks
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The MTD is reported below.
Group
Value
95% CI
Phase I (Stage 1)
6
Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better (Phase II)Primary· Up to 1 year
Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
0
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase I)Secondary· Up to 1 year
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below by stage for Phase I patients.
Group
Value
95% CI
Phase I: Stage 1 (MV-NIS Alone)
38
Phase I: Stage 2 (MV-NIS and Cyclophosphamide)
25
Number of Patients With Clinical Responses (Phase I)Secondary· Up to 1 year
The number of patients with clinical responses (CR, VGPR, PR, or minimal response \[MR\]) will be summarized by stage.
Group
Value
95% CI
Phase I: Stage 1 (MV-NIS Alone)
1
Phase I: Stage 2 (MV-NIS and Cyclophosphamide)
0
Overall Survival (Phase II)Secondary· Time from registration to death due to any cause, assessed up to 1 year
Time from registration to death due to any cause, assessed up to 1 year. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
12.0
5.6 – NA
Time to Progression (TTP) (Phase II)Secondary· Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year
Time from registration to the earliest date with documentation of disease progression, assessed up to 1 year. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
1.48
1.35 – 240
Progression-free Survival (Phase II)Secondary· At 1 year
1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
6.7
Progression-free Survival (Phase II)Secondary· At 2 years
2-year progression-free survival (PFS2). Evidence of local recurrence, distant metastasis, or death from any cause within 2 years counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
6.7
Progression-free Survival (Phase II)Secondary· Up to 5 years
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appe
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
1.48
1.35 – 2.40
Failure-free Survival (Phase II)Secondary· Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year
Time from registration to the earliest of progressive disease, alternative treatment for myeloma, or death due to any cause, assessed up to 1 year. The distribution of failure-free survival will be estimated using the method of Kaplan-Meier.
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
1.4783
1.2155 – 2.3982
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II)Secondary· Up to 1 year
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below for Phase II patients.
Group
Value
95% CI
Phase II (Acetaminophen + Benadryl + MV-NIS)
73.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
Serious: 2/3 (67%)
Deaths: 2/3
Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
Serious: 0/3 (0%)
Deaths: 2/3
Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
Serious: 0/3 (0%)
Deaths: 2/3
Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
Serious: 1/4 (25%)
Deaths: 2/4
Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
Serious: 1/4 (25%)
Deaths: 3/4
Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
Serious: 1/7 (14%)
Deaths: 5/7
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
Serious: 0/3 (0%)
Deaths: 2/3
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
Serious: 0/3 (0%)
Deaths: 3/3
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07509008 — Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Manageme
· Phase 1, PHASE2
· not yet recruiting
NCT07444632 — Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/
· Phase 1
· not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT07437963 — Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatmen
· Phase 1, PHASE2
· not yet recruiting
Other recruiting trials for Recurrent Plasma Cell Myeloma
Currently open trials in the same condition.
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· Phase 2
· active not recruiting
NCT05363111 — Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT05391750 — Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma
· Phase 1
· active not recruiting
NCT05514990 — Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AM
· Phase 1, PHASE2
· active not recruiting
NCT05312255 — Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple
· NA
· recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 16 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00450814.