Trial · NCT00552396
An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma
NCT00552396, Phase 1, Completed, Innate Pharma; results first posted 2012-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma. Trials, record NCT00552396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00552396
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma
- NCT number
- NCT00552396
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Innate Pharma
- Conditions
- Multiple Myeloma
- Interventions
- Anti-KIR (1-7F9)
- First posted
- 2007-11-01
- Last updated
- 2016-03-31
- Results first posted
- 2012-06-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | From start of the treatment to end of study | The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT. |
| Secondary | Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration | Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration | Cmax was obtained from the plasma concentration versus time data after IV administration of IPH2101. |
| Secondary | Area Under the Plasma-concentration-time Curve [AUC (INF)] of IPH2101 After Cycle 1 Administration | Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration | AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Cycle 1. |
| Secondary | Number of Evaluable Patients With Stable Disease. "Evaluable" is Defined as 2 Consecutive M Protein Assessments | From start of the treatment to end of study or disease progression | Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | From start of the treatment to end of study | All treated participants who received at least one dose of the study drug and were evaluable for DLT | Number of participants with DLT | NUMBER |
| SECONDARY | Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration | Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration | ng/mL | GEOMETRIC_MEAN | |
| SECONDARY | Area Under the Plasma-concentration-time Curve [AUC (INF)] of IPH2101 After Cycle 1 Administration | Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration | ng*hours/ml | GEOMETRIC_MEAN | |
| SECONDARY | Number of Evaluable Patients With Stable Disease. Evaluable is Defined as 2 Consecutive M Protein Assessments | From start of the treatment to end of study or disease progression | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | IPH2101 0.0003 mg/kg | 0 | Number of participants with DLT | ||
| Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | IPH2101 0.003 mg/kg | 0 | Number of participants with DLT | ||
| Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | IPH2101 0.015 mg/kg | 0 | Number of participants with DLT | ||
| Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | IPH2101 0.075 mg/kg | 1 | Number of participants with DLT | ||
| Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | IPH2101 0.3mg/kg | 0 | Number of participants with DLT | ||
| Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | IPH2101 1mg/kg | 0 | Number of participants with DLT | ||
| Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment | IPH2101 3 mg/kg | 0 | Number of participants with DLT | ||
| Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration | IPH2101 0.0003 mg/kg | 0 | Geometric Coefficient of Variation 0 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration | IPH2101 0.003 mg/kg | 45.8 | Geometric Coefficient of Variation 41.3 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration | IPH2101 0.015 mg/kg | 316 | Geometric Coefficient of Variation 53.8 | ng/mL |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.0003 mg/kg | 4 | |
| Overall Study | STARTED | 0.003 mg/kg | 3 | |
| Overall Study | STARTED | 0.015 mg/kg | 3 | |
| Overall Study | STARTED | 0.075 mg/kg | 6 | |
| Overall Study | STARTED | 0.3 mg/kg | 3 | |
| Overall Study | STARTED | 1 mg/kg | 3 | |
| Overall Study | STARTED | 3 mg/kg | 10 | |
| Overall Study | COMPLETED | 0.0003 mg/kg | 1 | |
| Overall Study | COMPLETED | 0.003 mg/kg | 0 | |
| Overall Study | COMPLETED | 0.015 mg/kg | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events350
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 | fatigue | General disorders | 0.0003 mg/kg | 0 | 4 | 0 |
| other | fatigue | General disorders | 0.003 mg/kg | 0 | 3 | 0 |
| other | fatigue | General disorders | 0.015 mg/kg | 1 | 3 | 1 |
| other | fatigue | General disorders | 0.075 mg/kg | 3 | 6 | 3 |
| other | fatigue | General disorders | 0.3 mg/kg | 0 | 3 | 0 |
| other | fatigue | General disorders | 1 mg/kg | 2 | 3 | 2 |
| other | fatigue | General disorders | 3 mg/kg | 4 | 10 | 4 |
| other | chills | General disorders | 0.0003 mg/kg | 0 | 4 | 0 |
| other | chills | General disorders | 0.003 mg/kg | 1 | 3 | 1 |
| other | chills | General disorders | 0.015 mg/kg | 0 | 3 | 0 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.0003 mg/kg | ||
| Total, all-cause mortality | 0.003 mg/kg | ||
| Total, all-cause mortality | 0.015 mg/kg | ||
| Total, all-cause mortality | 0.075 mg/kg | ||
| Total, all-cause mortality | 0.3 mg/kg | ||
| Total, all-cause mortality | 1 mg/kg | ||
| Total, all-cause mortality | 3 mg/kg | ||
| Total, other adverse events | 0.0003 mg/kg | 4 | 4 |
| Total, other adverse events | 0.003 mg/kg | 3 | 3 |
| Total, other adverse events | 0.015 mg/kg | 3 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23033266 | DERIVED |
Source PubMed
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/NCT00552396
GET https://conductscience.org/api/trials/v1/NCT00552396/results?page=2