Trial Outcomes & Findings for A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma (NCT NCT01248455)

Last Updated: 2019-11-19

Results Overview

Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR \>25% and \<50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium \>2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin \<10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

1 year

Results posted on

2019-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Anti-KIR in Smoldering Multiple Myeloma Patients Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Anti-KIR in Smoldering Multiple Myeloma Patients Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
Overall Study switched to alternate treatment	1

Baseline Characteristics

A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anti-KIR in Smoldering Multiple Myeloma Patients n=9 Participants Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	61.41 years STANDARD_DEVIATION 5.28 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).

Outcome measures

Outcome measures
Measure	Anti-KIR in Smoldering Multiple Myeloma Patients n=9 Participants Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
Response Rate Biochemical Progression (BP)	11 percentage of participants
Response Rate Progressive Disease (PD)	11 percentage of participants
Response Rate Minimal Response (MR)	11 percentage of participants
Response Rate Stable Disease (SD)	66 percentage of participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 3 years and 5 months

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Anti-KIR in Smoldering Multiple Myeloma Patients n=9 Participants Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
Count of Participants With Serious and Non-Serious Adverse Events	9 Participants

Adverse Events

Anti-KIR in Smoldering Multiple Myeloma Patients

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Anti-KIR in Smoldering Multiple Myeloma Patients n=9 participants at risk Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
Investigations Activated partial thromboplastin time prolonged	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations Alanine aminotransferase increased	44.4% 4/9 • Number of events 11 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations Alkaline phosphatase increased	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations Aspartate aminotransferase increased	66.7% 6/9 • Number of events 15 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations CPK increased	22.2% 2/9 • Number of events 6 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
General disorders Chills	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations Creatinine increased	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Skin and subcutaneous tissue disorders Dry skin	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Skin and subcutaneous tissue disorders Erythema multiforme	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Injury, poisoning and procedural complications Fall	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
General disorders Fatigue	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
General disorders Fever	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Eye disorders Flashing lights	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Eye disorders Floaters	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
General disorders Flu like symptoms	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Injury, poisoning and procedural complications Fracture	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Infections and infestations Hepatitis viral	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hypercalcemia	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hyperglycemia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hyperkalemia	55.6% 5/9 • Number of events 8 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hypermagnesemia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hypernatremia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Endocrine disorders Hyperparathyroidism	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hyperuricemia	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hypoalbuminemia	88.9% 8/9 • Number of events 22 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 3/9 • Number of events 7 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Metabolism and nutrition disorders Hypophosphatemia	22.2% 2/9 • Number of events 9 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Endocrine disorders Hypothyroidism	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations Lymphocyte count decreased	66.7% 6/9 • Number of events 15 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	22.2% 2/9 • Number of events 4 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Nervous system disorders Nervous system disorders - Other, carpal tunnel syndrome	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations Neutrophil count decreased	11.1% 1/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Musculoskeletal and connective tissue disorders Osteoporosis	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
General disorders Pain	22.2% 2/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Musculoskeletal and connective tissue disorders Pain in extremity	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations Platelet count decreased	33.3% 3/9 • Number of events 8 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Cardiac disorders Sinus bradycardia	22.2% 2/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, scalp lesion/scab	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Respiratory, thoracic and mediastinal disorders Sore throat	11.1% 1/9 • Number of events 2 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Gastrointestinal disorders Stomach pain	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Nervous system disorders Tremor	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Infections and infestations Upper respiratory infection	33.3% 3/9 • Number of events 3 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Renal and urinary disorders Urinary retention	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Respiratory, thoracic and mediastinal disorders Wheezing	11.1% 1/9 • Number of events 1 • Date treatment consent signed to date off study, approximately 3 years and 5 months.
Investigations White blood cell decreased	55.6% 5/9 • Number of events 16 • Date treatment consent signed to date off study, approximately 3 years and 5 months.

Additional Information

Dr. Dickran Kazandijian

National Cancer Institute

Phone: 301-480-0532

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place