Trial Outcomes & Findings for Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma (NCT NCT00999830)

Last Updated: 2016-03-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

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

Results posted on

2016-03-24

Participant Flow

Patients were recruited in France at the public hospital (10 actives center), from mid of November 2009 to end of October 2011.

All patients enrolled in the study were analyzed. There was no screen failure during the trial conduct.

Participant milestones

Participant milestones
Measure	Arm A: IPH2101 0.2mg/Kg IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.	Arm B: IPH2101 2mg/kg IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
Overall Study STARTED	14	13
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: IPH2101 0.2mg/Kg n=14 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.	Arm B: IPH2101 2mg/kg n=13 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 5.6 • n=93 Participants	55.9 years STANDARD_DEVIATION 10.2 • n=4 Participants	57.3 years STANDARD_DEVIATION 8.1 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	7 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment France	14 participants n=93 Participants	13 participants n=4 Participants	27 participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Arm A: IPH2101 0.2mg/Kg n=14 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.	Arm B: IPH2101 2mg/kg n=13 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains	0 participants	1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A: IPH2101 0.2mg/Kg n=14 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.	Arm B: IPH2101 2mg/kg n=13 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment	80.5 % of occupancy Interval 33.8 to 95.0	96.8 % of occupancy Interval 93.0 to 99.4

SECONDARY outcome

Timeframe: from screening visit to the End of Study (at each study visit)

Adverse Events, Serious Adverse Events, physical examination and biological changes.

Outcome measures

Outcome measures
Measure	Arm A: IPH2101 0.2mg/Kg n=14 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.	Arm B: IPH2101 2mg/kg n=13 Participants every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
Safety Assessment	14 participants	11 participants

Adverse Events

Arm A: IPH2101 0.2mg/Kg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Arm B: IPH2101 2mg/kg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: IPH2101 0.2mg/Kg n=14 participants at risk every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.	Arm B: IPH2101 2mg/kg n=13 participants at risk every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
Respiratory, thoracic and mediastinal disorders Bronchitis	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	0.00% 0/13 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Blood and lymphatic system disorders Disease progression	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	0.00% 0/13 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study

Other adverse events

Additional Information

Dr Michel ATTAL

HOPITAL DE PURPAN Service Hematologie

Phone: +33 (0)5.61.77.77.84

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A: IPH2101 0.2mg/Kg n=14 participants at risk every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.	Arm B: IPH2101 2mg/kg n=13 participants at risk every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Nervous system disorders Headache	14.3% 2/14 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	23.1% 3/13 • Number of events 3 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	15.4% 2/13 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Skin and subcutaneous tissue disorders Erythema	0.00% 0/14 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	15.4% 2/13 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Gastrointestinal disorders Constipation	14.3% 2/14 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	0.00% 0/13 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	0.00% 0/13 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Gastrointestinal disorders Dry mouth	0.00% 0/14 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	15.4% 2/13 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
General disorders Asthenia	28.6% 4/14 • Number of events 4 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	15.4% 2/13 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
General disorders Fatigue	21.4% 3/14 • Number of events 3 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	15.4% 2/13 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
General disorders Pyrexia	14.3% 2/14 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	23.1% 3/13 • Number of events 3 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
General disorders Chills	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	23.1% 3/13 • Number of events 3 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Infections and infestations Bronchitis	21.4% 3/14 • Number of events 3 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	15.4% 2/13 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Infections and infestations Rhinitis	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	15.4% 2/13 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Infections and infestations Nasopharyngitis	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Infections and infestations Pharyngitis	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Musculoskeletal and connective tissue disorders Muscle spasms	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	30.8% 4/13 • Number of events 4 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Musculoskeletal and connective tissue disorders Back pain	14.3% 2/14 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	14.3% 2/14 • Number of events 2 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study	7.7% 1/13 • Number of events 1 • Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study