Comparison · NCT01864018-edf092a7
Phase I/II, Cohort A vs Phase II, Cohort B: Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Phase I/II, Cohort A vs Phase II, Cohort B: Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Trial comparisons, record NCT01864018-edf092a7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01864018-edf092a7
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.75 | 0.612 | 0.851 | wilson | |
| Risk in group 2 | 0.457 | 0.305 | 0.618 | wilson | |
| Risk difference, group 1 minus group 2 | 0.293 | 0.0809 | 0.476 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.64 | 1.1 | 2.44 | log | |
| Odds ratio, group 1 over group 2 | 3.56 | 1.4 | 9.05 | log | |
| Number needed to treat, for one more participant with the outcome on Phase I/II, Cohort A than on Phase II, Cohort B | 3.41 | 2.1 | 12.4 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Phase I/II, Cohort A | Patients with multiple myeloma\>~\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>~\>\>~\>~\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>~\>\>~\>~\>\> Cyclophosphamide: Given PO\>~\>\>~\>~\>\> Dexamethasone: Given PO\>~\>\>~\>~\>\> Ixazomib Citrate: Given PO\>~\>\>~\>~\>\> Laboratory Biomarker Analysis: Correlative studies\>~\>\>~\>~\>\> Pharmacological Study: Correlative studies\>~\>\>~\>~\>\> Quality-of-Life Assessment: Ancillary studies\>~\>\>~\>~\>\> Questionnaire Administration: Ancillary studies | 36 | 48 | OG000 |
| Group 2 | Phase II, Cohort B | Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\>~\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\>~\>\>~\>~\>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\>~\>\>~\>~\>\> Cyclophosphamide: Given PO\>~\>\>~\>~\>\> Dexamethasone: Given PO\>~\>\>~\>~\>\> Ixazomib Citrate: Given PO\>~\>\>~\>~\>\> Laboratory Biomarker Analysis: Correlative studies\>~\>\>~\>~\>\> Pharmacological Study: Correlative studies\>~\>\>~\>~\>\> Quality-of-Life Assessment: Ancillary studies\>~\>\>~\>~\>\> Questionnaire Administration: Ancillary studies | 16 | 35 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
- Description
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. A grade 3 event is one that is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
- Time frame
- Up to 5 years
- Population
Source ClinicalTrials.gov
Trial
- Title
- Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
- NCT number
- NCT01864018
- Phases
- PHASE1, PHASE2
- Conditions
- Amyloidosis, Plasma Cell Myeloma
- Interventions
- Cyclophosphamide, Dexamethasone, Ixazomib Citrate, Laboratory Biomarker Analysis, Pharmacological Study, Quality-of-Life Assessment, Questionnaire Administration
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2022-09-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01864018?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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