Trial Outcomes & Findings for Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma (NCT NCT02548962)
NCT ID: NCT02548962
Last Updated: 2019-11-21
Results Overview
The overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
14 Months
Results posted on
2019-11-21
Participant Flow
Participant milestones
| Measure |
Phase 1: Dose Finding (560mg)
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Dose Finding (560mg)
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Finding (560mg)
n=8 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
n=3 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Total
n=11 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
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
72.7 years
n=7 Participants
|
67.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 MonthsThe overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy
Outcome measures
| Measure |
Phase 1: Dose Finding (560mg)
n=8 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
n=3 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
|---|---|---|
|
Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 MonthsThe clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.
Outcome measures
| Measure |
Phase 1: Dose Finding (560mg)
n=8 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
n=3 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
|---|---|---|
|
Clinical Benefit Response (CBR)
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 14 MonthsPopulation: Median was not reached for Phase 1: Dose Finding (560 mg). Median value provided here was the median and range (min and max).
The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.
Outcome measures
| Measure |
Phase 1: Dose Finding (560mg)
n=3 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
n=1 Participants
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
|---|---|---|
|
Duration of Response (DOR)
|
6.5 Months
Interval 5.1 to 11.8
|
7.3 Months
Interval 7.3 to 7.3
|
Adverse Events
Phase 1: Dose Finding (560mg)
Serious events: 8 serious events
Other events: 8 other events
Deaths: 1 deaths
Phase 1: Dose Finding (840mg)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1: Dose Finding (560mg)
n=8 participants at risk
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
n=3 participants at risk
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Cardiac disorders
Atrial Fibrilation
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Cardiac disorders
Cardio-respiratory Arrest
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Vascular disorders
Embolism
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Lobular Breast Carcinoma
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of Jaw
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Periorbital Cellulitis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Nervous system disorders
Sciatica
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
Other adverse events
| Measure |
Phase 1: Dose Finding (560mg)
n=8 participants at risk
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (560mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
Phase 1: Dose Finding (840mg)
n=3 participants at risk
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Ibrutinib (840mg)
Pomalidomide (4mg)
Dexamethasone (40mg)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
6/8 • 14 Months
|
66.7%
2/3 • 14 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
4/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
4/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Blood and lymphatic system disorders
Increased Tendency to Bruise
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Blood and lymphatic system disorders
Spontaneous Haematoma
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Cardiac disorders
Mitral Valve Prolapse
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Cardiac disorders
Sinus Tachycardia
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Eye disorders
Cataract
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Eye disorders
Eye Oedema
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • 14 Months
|
66.7%
2/3 • 14 Months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • 14 Months
|
66.7%
2/3 • 14 Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
General disorders
Fatigue
|
62.5%
5/8 • 14 Months
|
66.7%
2/3 • 14 Months
|
|
General disorders
Oedema Peripheral
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
General disorders
Pyrexia
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
General disorders
Injection Site Haemorrhage
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
General disorders
Non-Cardiac Chest Pain
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
General disorders
Peripheral Swelling
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
50.0%
4/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Otitis Media
|
25.0%
2/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Infections and infestations
Oral Herpes
|
25.0%
2/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Folliculitis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Furuncle
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Infections and infestations
Osteomyelitis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Infections and infestations
Respiratory Tract Infection
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Steptococcal Sepsis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Infections and infestations
Viral Infection
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Investigations
Alanine Aminotransferase Increased
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Investigations
Blood Creatinine Increased
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
25.0%
2/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
12.5%
1/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
25.0%
2/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Skin and subcutaneous tissue disorders
Purpura Senile
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
12.5%
1/8 • 14 Months
|
0.00%
0/3 • 14 Months
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • 14 Months
|
33.3%
1/3 • 14 Months
|
Additional Information
Dr. Bernhard Hauns, Medical Monitor
Pharmacyclics Switzerland GmbH
Phone: +41 52 556 0800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place