Trial · NCT00999830
Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma
NCT00999830, Phase 2, Completed, Innate Pharma; results first posted 2016-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma. Trials, record NCT00999830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00999830
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma
- NCT number
- NCT00999830
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Innate Pharma
- Conditions
- Multiple Myeloma
- Interventions
- IPH2101
- First posted
- 2009-10-22
- Last updated
- 2016-03-24
- Results first posted
- 2016-03-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Patients Achieving a Response Based on M-protein or Free Light Chains | 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 | 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. |
| Secondary | Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment | From the start up to the end of study (15 months) | KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands. |
| Secondary | Safety Assessment | from screening visit to the End of Study (at each study visit) | Adverse Events, Serious Adverse Events, physical examination and biological changes. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Patients Achieving a Response Based on M-protein or Free Light Chains | 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 | participants | NUMBER | |
| SECONDARY | Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment | From the start up to the end of study (15 months) | % of occupancy | MEDIAN | |
| SECONDARY | Safety Assessment | from screening visit to the End of Study (at each study visit) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Patients Achieving a Response Based on M-protein or Free Light Chains | Arm A: IPH2101 0.2mg/Kg | 0 | participants | ||
| Rate of Patients Achieving a Response Based on M-protein or Free Light Chains | Arm B: IPH2101 2mg/kg | 1 | participants | ||
| Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment | Arm A: IPH2101 0.2mg/Kg | 80.5 | Full Range 33.8 to 95 | % of occupancy | |
| Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment | Arm B: IPH2101 2mg/kg | 96.8 | Full Range 93 to 99.4 | % of occupancy | |
| Safety Assessment | Arm A: IPH2101 0.2mg/Kg | 14 | participants | ||
| Safety Assessment | Arm B: IPH2101 2mg/kg | 11 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: IPH2101 0.2mg/Kg | 14 | |
| Overall Study | STARTED | Arm B: IPH2101 2mg/kg | 13 | |
| Overall Study | COMPLETED | Arm A: IPH2101 0.2mg/Kg | 14 | |
| Overall Study | COMPLETED | Arm B: IPH2101 2mg/kg | 13 | |
| Overall Study | NOT COMPLETED | Arm A: IPH2101 0.2mg/Kg | 0 | |
| Overall Study | NOT COMPLETED | Arm B: IPH2101 2mg/kg | 0 |
Source ClinicalTrials.gov
Adverse events46
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 | Abdominal pain upper | Gastrointestinal disorders | Arm A: IPH2101 0.2mg/Kg | 1 | 14 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Arm B: IPH2101 2mg/kg | 1 | 13 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm A: IPH2101 0.2mg/Kg | 2 | 14 | 2 |
| other | Constipation | Gastrointestinal disorders | Arm B: IPH2101 2mg/kg | 0 | 13 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Arm A: IPH2101 0.2mg/Kg | 2 | 14 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Arm B: IPH2101 2mg/kg | 0 | 13 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Arm A: IPH2101 0.2mg/Kg | 0 | 14 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Arm B: IPH2101 2mg/kg | 2 | 13 | 2 |
| other | Nausea | Gastrointestinal disorders | Arm A: IPH2101 0.2mg/Kg | 1 | 14 | 1 |
| other | Nausea | Gastrointestinal disorders | Arm B: IPH2101 2mg/kg | 1 | 13 | 1 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: IPH2101 0.2mg/Kg | ||
| Total, all-cause mortality | Arm B: IPH2101 2mg/kg | ||
| Total, other adverse events | Arm A: IPH2101 0.2mg/Kg | 14 | 14 |
| Total, other adverse events | Arm B: IPH2101 2mg/kg | 11 | 13 |
| Total, serious adverse events | Arm A: IPH2101 0.2mg/Kg | 2 | 14 |
| Total, serious adverse events | Arm B: IPH2101 2mg/kg | 0 | 13 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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 |
| Arm A: IPH2101 0.2mg/Kg vs Arm B: IPH2101 2mg/kg: Safety Assessment | Trial comparisons |
| Arm A: IPH2101 0.2mg/Kg vs Arm B: IPH2101 2mg/kg: serious adverse events | Trial comparisons |
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/NCT00999830
GET https://conductscience.org/api/trials/v1/NCT00999830/events?page=2