Comparison · NCT00999830-363fe350
Arm A: IPH2101 0.2mg/Kg vs Arm B: IPH2101 2mg/kg: Rate of Patients Achieving a Response Based on M-protein or Free Light Chains
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. Arm A: IPH2101 0.2mg/Kg vs Arm B: IPH2101 2mg/kg: Rate of Patients Achieving a Response Based on M-protein or Free Light Chains. Trial comparisons, record NCT00999830-363fe350. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00999830-363fe350
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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 | 0.0000000000000000139 | 0.215 | wilson | |
| Risk in group 2 | 0.0769 | 0.0137 | 0.333 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0769 | -0.333 | 0.147 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Arm A: IPH2101 0.2mg/Kg than on Arm B: IPH2101 2mg/kg | 13 | from the risk difference interval | the interval includes no difference |
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 | Arm A: IPH2101 0.2mg/Kg | every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles. | 0 | 14 | OG000 |
| Group 2 | Arm B: IPH2101 2mg/kg | every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles. | 1 | 13 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Rate of Patients Achieving a Response Based on M-protein or Free Light Chains
- Description
Response was defined:~* In patients with a serum M-protein \> 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;~* In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis~* In patients with serum M-protein \< 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (\<0.26 or \> 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.
- Time frame
- From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices
- Population
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma
- NCT number
- NCT00999830
- Phases
- PHASE2
- Conditions
- Multiple Myeloma
- Interventions
- IPH2101
- Lead sponsor
- Innate Pharma
- Results first posted
- 2016-03-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00999830?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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