Trial · NCT04119336
Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma
NCT04119336, Phase 2, Terminated, Andrew Yee, MD; results first posted 2023-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma. Trials, record NCT04119336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04119336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Myeloma
- NCT number
- NCT04119336
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Andrew Yee, MD
- Conditions
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Interventions
- Nivolumab, Ixazomib, Dexamethasone, Cyclophosphamide
- First posted
- 2019-10-08
- Last updated
- 2023-08-21
- Results first posted
- 2023-08-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | up to 8 months | ORR is defined as percentage of participants with complete response (CR) and partial response (PR) per International Myeloma Working Group (IMWG) criteria below. * CR = Negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow * Stringent CR = Above definition plus normal FLC ration and absence of clonal cells in bone marrow by IHC or 2-4 color flow cytometry * PR = At least 50% reduction of serum M-protein and reduction in 24 urinary M-protein by at least 90% or to \<200 mg/24 h. If serum and urine M-protein unmeasurable, require at least 50% decrease in difference between involved and uninvolved FLC levels. If serum free light assay also unmeasurable, require at least 50% reduction in plasma cells, provided baseline was at least 30% * Very Good PR (VGPR) = Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or \>90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h |
| Secondary | Progression Free Survival | Up to 2 years | Progression-free survival (PFS) is defined as the time from starting study treatment to disease progression or death from any cause. The International Myeloma Working Group (IMWG) criteria defines progressive disease (PD) as at least 25% increase from lowest response value of any of the following: * Serum M-component (absolute increase must be at least 0.5 g/dL) * Urine M-component (absolute increase must be at least 200 mg/24 h) * If serum and urine M-protein unmeasurable, absolute increase in free light chain (FLC) must be \>10 mg/dL. If FLC levels also unmeasurable, absolute increase in bone marrow plasma cell percentage must be at least 10%. * Definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | up to 8 months | percentage of participants | NUMBER | |
| SECONDARY | Progression Free Survival | Up to 2 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Nivolumab and Ixazomib | 0 | percentage of participants | ||
| Progression Free Survival | Nivolumab and Ixazomib | 3.96 | 95% Confidence Interval 1.15 to NA | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab and Ixazomib | 2 | |
| Overall Study | COMPLETED | Nivolumab and Ixazomib | 2 | |
| Overall Study | NOT COMPLETED | Nivolumab and Ixazomib | 0 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Nivolumab and Ixazomib | 1 | 2 | |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Nivolumab and Ixazomib | 1 | 2 | |
| other | Fatigue | General disorders | Nivolumab and Ixazomib | 1 | 2 | |
| other | Pain | General disorders | Nivolumab and Ixazomib | 1 | 2 | |
| other | Aspartate aminotransferase increased | Investigations | Nivolumab and Ixazomib | 1 | 2 | |
| other | Alkaline phosphatase increased | Investigations | Nivolumab and Ixazomib | 1 | 2 | |
| other | White blood cell decreased | Investigations | Nivolumab and Ixazomib | 1 | 2 | |
| other | Neutrophil count decreased | Investigations | Nivolumab and Ixazomib | 1 | 2 | |
| other | Platelet count decreased | Investigations | Nivolumab and Ixazomib | 1 | 2 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Nivolumab and Ixazomib | 1 | 2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab and Ixazomib | 2 | 2 |
| Total, other adverse events | Nivolumab and Ixazomib | 2 | 2 |
| Total, serious adverse events | Nivolumab and Ixazomib | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04119336
GET https://conductscience.org/api/trials/v1/NCT04119336/registered