Trial Outcomes & Findings for Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma (NCT NCT01222286)
NCT ID: NCT01222286
Last Updated: 2014-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
from start to end of study (14 months)
Results posted on
2014-05-09
Participant Flow
There were 44 patients screened, 14 subjects were not randomized, 12 of whom were screen failures, 30 patients randomized.
All patients enrolled were screened in order to verify the inclusion/exclusion criteria. All patients enrolled (30 patients) were analyzed.
Participant milestones
| Measure |
IPH2101 0.2 mg/kg
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
IPH2101 0.2 mg/kg
n=16 Participants
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
n=14 Participants
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 7.62 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 13.11 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from start to end of study (14 months)Population: The ITT population included all randomized subjects.
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.
Outcome measures
| Measure |
IPH2101 0.2 mg/kg
n=16 Participants
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
n=14 Participants
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
|---|---|---|
|
Rate of Patients Achieving an Objective Response
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 monthsPopulation: The safety population included all subjects who received at least 1 dose of IPH2101
adverse events, physical examination and biological changes during the whole clinical trial.
Outcome measures
| Measure |
IPH2101 0.2 mg/kg
n=16 Participants
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
n=14 Participants
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
|---|---|---|
|
Safety Assessment
|
16 Patients with any AE
|
14 Patients with any AE
|
SECONDARY outcome
Timeframe: from start to end of study (14 months)Population: all subjects who received at least 1 dose of IPH2101
biological activity of IPH2101 on KIR occupancy at End of Treatment
Outcome measures
| Measure |
IPH2101 0.2 mg/kg
n=9 Participants
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
n=11 Participants
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
|---|---|---|
|
Pharmacodynamics of IPH2101
|
73.1 % of occupancy of killer like receptor
Interval 46.0 to 98.0
|
92 % of occupancy of killer like receptor
Interval 80.0 to 96.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
IPH2101 0.2 mg/kg
n=16 Participants
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
n=14 Participants
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
|---|---|---|
|
Secondary Anti-tumor Activity
serum M-protein progression
|
4 Participant
|
8 Participant
|
|
Secondary Anti-tumor Activity
Progression to active Multiple Myeloma
|
2 Participant
|
3 Participant
|
Adverse Events
IPH2101 0.2 mg/kg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
IPH2101 2 mg/kg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPH2101 0.2 mg/kg
n=16 participants at risk
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
n=14 participants at risk
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
Other adverse events
| Measure |
IPH2101 0.2 mg/kg
n=16 participants at risk
0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
IPH2101 2 mg/kg
n=14 participants at risk
2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
|
|---|---|---|
|
General disorders
Fatigue
|
31.2%
5/16 • Number of events 5 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
35.7%
5/14 • Number of events 5 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
4/16 • Number of events 4 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
General disorders
Chills
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
21.4%
3/14 • Number of events 3 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
14.3%
2/14 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
21.4%
3/14 • Number of events 3 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
General disorders
Pyrexia
|
18.8%
3/16 • Number of events 3 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
21.4%
3/14 • Number of events 3 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
14.3%
2/14 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
General disorders
Edema Peripheral
|
0.00%
0/16 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
14.3%
2/14 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/16 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
14.3%
2/14 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/16 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
14.3%
2/14 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Gastrointestinal disorders
vomiting
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
14.3%
2/14 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Gastrointestinal disorders
abdominal pain
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Investigations
neutrophil count decreased
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
14.3%
2/14 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Investigations
blood creatinine increased
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Investigations
white blood cell count decreased
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Metabolism and nutrition disorders
decreased appetite
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Metabolism and nutrition disorders
hyperkalemia
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Injury, poisoning and procedural complications
contusion
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
6.2%
1/16 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
7.1%
1/14 • Number of events 1 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
|
Immune system disorders
seasonal allergy
|
12.5%
2/16 • Number of events 2 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
0.00%
0/14 • Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place