Comparison · NCT04272775-57f7b1d6
Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Cohort 1: Ixazomib 4.0 mg vs Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs). Trial comparisons, record NCT04272775-57f7b1d6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04272775-57f7b1d6
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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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.42 | 0.42 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0796 | 12.6 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.048 | 20.8 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Cohort 1: Ixazomib 4.0 mg | Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87. | 1 | 6 | OG000 |
| Group 2 | Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone | Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62. | 1 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
- Description
DLT:Any following adverse events (AEs) possibly related to ixazomib assessed by Common Terminology Criteria for AEs (CTCAE) version 4.03; Grade 4 neutropenia/thrombocytopenia lasting \>7 consecutive days; Grade 3/greater neutropenia with fever/infections; Grade 3/greater thrombocytopenia with clinically significant bleeding; platelet count less than (\<)10,000 per cubic meter(/mm\^3); Grade 2 peripheral neuropathy with pain/Grade 3 or greater peripheral neuropathy; Grade 3/greater nonhematologic toxicities with exceptions of arthralgia/myalgia, fatigue lasting \<7 days manageable nausea/emesis with antiemetic prophylaxis, diarrhea that is controlled with supportive care; treatment delay of \>14 days at start of Cycle 2 due to failure of hematologic/nonhematologic recovery; Other Grade 2/greater ixazomib related nonhematologic toxicities required permanent discontinuation of ixazomib;Inability to receive at least 80% of planned lenalidomide doses due to the AEs related to ixazomib.
- Time frame
- From Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle length is equal to [=] 28 days)
- Population
- The DLT analysis set consisted of DLT evaluable participants who received at least one dose of ixazomib.
Source ClinicalTrials.gov
Trial
- Title
- A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- NCT number
- NCT04272775
- Phases
- PHASE1
- Conditions
- Relapsed and/or Refractory Multiple Myeloma
- Interventions
- Ixazomib, Lenalidomide, Dexamethasone
- Lead sponsor
- Takeda
- Results first posted
- 2020-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04272775?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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