Trial · NCT01222286

Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma

NCT01222286, Phase 2, Completed, Innate Pharma; results first posted 2014-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma. Trials, record NCT01222286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01222286

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma
NCT number: NCT01222286
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Innate Pharma
Conditions: Smoldering Multiple Myeloma
Interventions: IPH2101
First posted: 2010-10-18
Last updated: 2026-05-14
Results first posted: 2014-05-09

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rate of Patients Achieving an Objective Response	from start to end of study (14 months)	The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.
Secondary	Safety Assessment	Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months	adverse events, physical examination and biological changes during the whole clinical trial.
Secondary	Pharmacodynamics of IPH2101	from start to end of study (14 months)	biological activity of IPH2101 on KIR occupancy at End of Treatment
Secondary	Secondary Anti-tumor Activity	from start to end of study (14 months)	* any change of M-protein in serum occurring during the study (\>25 percentage increase in level of serum M-protein) * progression to active Multiple Myeloma Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder : * Development of new soft tissue plasmacytomas or bone lesions * Hypercalcemia (\> 11mg/100ml) * Decrease in hemoglobin of \> 2g/100ml * Rise in serum creatinine by 2 mg/100ml or more

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	Rate of Patients Achieving an Objective Response	from start to end of study (14 months)	The ITT population included all randomized subjects.	participants	NUMBER
SECONDARY	Safety Assessment	Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months	The safety population included all subjects who received at least 1 dose of IPH2101	Patients with any AE	NUMBER
SECONDARY	Pharmacodynamics of IPH2101	from start to end of study (14 months)	all subjects who received at least 1 dose of IPH2101	% of occupancy of killer like receptor	MEAN
SECONDARY	Secondary Anti-tumor Activity	from start to end of study (14 months)		Participant	NUMBER

Source ClinicalTrials.gov

Results by group10

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 an Objective Response	IPH2101 0.2 mg/kg		0		participants
Rate of Patients Achieving an Objective Response	IPH2101 2 mg/kg		0		participants
Safety Assessment	IPH2101 0.2 mg/kg		16		Patients with any AE
Safety Assessment	IPH2101 2 mg/kg		14		Patients with any AE
Pharmacodynamics of IPH2101	IPH2101 0.2 mg/kg		73.1	Full Range 46 to 98	% of occupancy of killer like receptor
Pharmacodynamics of IPH2101	IPH2101 2 mg/kg		92	Full Range 80 to 96	% of occupancy of killer like receptor
Secondary Anti-tumor Activity	IPH2101 0.2 mg/kg	serum M-protein progression	4		Participant
Secondary Anti-tumor Activity	IPH2101 2 mg/kg	serum M-protein progression	8		Participant
Secondary Anti-tumor Activity	IPH2101 0.2 mg/kg	Progression to active Multiple Myeloma	2		Participant
Secondary Anti-tumor Activity	IPH2101 2 mg/kg	Progression to active Multiple Myeloma	3		Participant

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IPH2101 0.2 mg/kg	16
Overall Study	STARTED	IPH2101 2 mg/kg	14
Overall Study	COMPLETED	IPH2101 0.2 mg/kg	16
Overall Study	COMPLETED	IPH2101 2 mg/kg	14
Overall Study	NOT COMPLETED	IPH2101 0.2 mg/kg	0
Overall Study	NOT COMPLETED	IPH2101 2 mg/kg	0

Source ClinicalTrials.gov

Adverse events56

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	IPH2101 0.2 mg/kg	5	16	5
other	Fatigue	General disorders	IPH2101 2 mg/kg	5	14	5
other	Rash	Skin and subcutaneous tissue disorders	IPH2101 0.2 mg/kg	4	16	4
other	Rash	Skin and subcutaneous tissue disorders	IPH2101 2 mg/kg	0	14	0
other	Chills	General disorders	IPH2101 0.2 mg/kg	2	16	2
other	Chills	General disorders	IPH2101 2 mg/kg	3	14	3
other	Diarrhea	Gastrointestinal disorders	IPH2101 0.2 mg/kg	1	16	1
other	Diarrhea	Gastrointestinal disorders	IPH2101 2 mg/kg	2	14	2
other	Dizziness	Nervous system disorders	IPH2101 0.2 mg/kg	2	16	2
other	Dizziness	Nervous system disorders	IPH2101 2 mg/kg	3	14	3

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IPH2101 0.2 mg/kg
Total, all-cause mortality	IPH2101 2 mg/kg
Total, other adverse events	IPH2101 0.2 mg/kg	12	16
Total, other adverse events	IPH2101 2 mg/kg	12	14
Total, serious adverse events	IPH2101 0.2 mg/kg	2	16
Total, serious adverse events	IPH2101 2 mg/kg	0	14

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
IPH2101 0.2 mg/kg vs IPH2101 2 mg/kg: Rate of Patients Achieving an Objective Response	Trial comparisons
IPH2101 0.2 mg/kg vs IPH2101 2 mg/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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01222286

GET https://conductscience.org/api/trials/v1/NCT01222286/events?page=2

API reference For AI assistants