Trial Outcomes & Findings for Study of Ibrutinib in Combination With Revlimid/Dexamethasone in Relapsed/Refractory Multiple Myeloma (NCT NCT03702725)
NCT ID: NCT03702725
Last Updated: 2026-01-06
Results Overview
DLTs were grade 4 thrombocytopenia; grade 4 neutropenia lasting \> 5 days or febrile neutropenia; grade 3 thrombocytopenia with bleeding or platelet transfusion; grade 3-4 hyperglycemia or a thrombotic/embolic event; or grade 3-4 non-hematologic toxicity (except grade 3 nausea, diarrhea, and vomiting), that were at least probably related to treatment, treatment delays ≥ 21 days for toxicity, and treatment-related death.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
During cycle 1 (28-day cycle)
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Dose Level 1 (Starting DL)
Ibrutinib 560 mg on Days 1-28,\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\>
\> Every 28 days
|
Dose Level 2
Ibrutinib 560 mg on Days 1-28,\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\>
\> Every 28 days
|
Dose Level 3
Ibrutinib 840 mg on Days 1-28,\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\>
\> Every 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
4
|
|
Overall Study
COMPLETED
|
6
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Ibrutinib in Combination With Revlimid/Dexamethasone in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Dose Level 1 (Starting DL)
n=6 Participants
Ibrutinib 560 mg on Days 1-28,\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\>
\> Every 28 days
|
Dose Level 2
n=3 Participants
Ibrutinib 560 mg on Days 1-28,\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\>
\> Every 28 days
|
Dose Level 3
n=4 Participants
Ibrutinib 840 mg on Days 1-28,\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22\>
\> Every 28 days
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=37 Participants
|
68 years
n=56 Participants
|
64.5 years
n=82 Participants
|
64 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=82 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
3 Participants
n=82 Participants
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: During cycle 1 (28-day cycle)Population: Eligible patients who started protocol treatment were excluded from the determination of MTD if they failed to completed one cycle of treatments for reasons other than toxicity. Specifically. two patient assigned to DL3 were excluded from MTD determination: one developed COVID-19 infection and the other received 280 mg/day of IBR instead of the assigned 840 mg/day dose during cycle 1.
DLTs were grade 4 thrombocytopenia; grade 4 neutropenia lasting \> 5 days or febrile neutropenia; grade 3 thrombocytopenia with bleeding or platelet transfusion; grade 3-4 hyperglycemia or a thrombotic/embolic event; or grade 3-4 non-hematologic toxicity (except grade 3 nausea, diarrhea, and vomiting), that were at least probably related to treatment, treatment delays ≥ 21 days for toxicity, and treatment-related death.
Outcome measures
| Measure |
Dose Level 1 (Starting DL)
n=6 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 2
n=3 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 3
n=2 Participants
Ibrutinib 840 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 34 monthPopulation: All eligible patients who began protocol treatment.
The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (Grade 3 or higher) will be determined. Adverse Events were graded using CTCAE v4.0.
Outcome measures
| Measure |
Dose Level 1 (Starting DL)
n=6 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 2
n=3 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 3
n=4 Participants
Ibrutinib 840 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
|---|---|---|---|
|
Maximum Toxicity Grade
Grade 3
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Maximum Toxicity Grade
Grade 4
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Maximum Toxicity Grade
Grade 5
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 34 MonthsPopulation: Per-protocol - all eligible patients who initiated protocol treatment regardless of DL received
Progression-free survival time is the time from study entry to the documentation of disease progression or death due to any cause.
Outcome measures
| Measure |
Dose Level 1 (Starting DL)
n=6 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 2
n=3 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 3
n=4 Participants
Ibrutinib 840 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
|---|---|---|---|
|
Progression Free Survival
|
215 days
Interval 56.0 to
There are not enough events to calculate upper confidence bound.
|
106 days
Interval 85.0 to
There are not enough events to calculate upper confidence bound.
|
102 days
Interval 56.0 to
There are not enough events to calculate upper confidence bound.
|
SECONDARY outcome
Timeframe: 34 MonthsPopulation: Per-protocol - all eligible patients who initiated protocol treatment regardless of DL received
Overall survival (OS) is defined as time from registration to death due to any cause.
Outcome measures
| Measure |
Dose Level 1 (Starting DL)
n=6 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 2
n=3 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 3
n=4 Participants
Ibrutinib 840 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
|---|---|---|---|
|
Overall Survival
|
NA Days
median and confidence interval not estimable due to an insufficient number of participants with events
|
404 Days
Interval 208.0 to
median and confidence interval not estimable due to an insufficient number of participants with events
|
254 Days
Interval 80.0 to
median and confidence interval not estimable due to an insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 34 MonthsPopulation: All eligible patients who met IMWG criteria for CR, VGPR, or PR on two consecutive evaluations at least 4 weeks apart
The duration of response is the time from initiation of first response to first documentation of disease progression or death. Patients who have not progressed will be censored at the date of their last disease evaluation.
Outcome measures
| Measure |
Dose Level 1 (Starting DL)
n=1 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 2
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 3
n=1 Participants
Ibrutinib 840 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
|---|---|---|---|
|
Duration of Response
|
7.1 months
|
—
|
3.1 months
|
SECONDARY outcome
Timeframe: Up to 34 monthsThe objective response rate is the percent of patients who meet the International Myeloma Working Group Response Criteria for sCR, CR, VGPR, or PR on two consecutive evaluations at least 4 weeks apart among the patients who began study treatment. A 90% binomial confidence interval will be constructed for the overall objective response rate.
Outcome measures
| Measure |
Dose Level 1 (Starting DL)
n=6 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 2
n=3 Participants
Ibrutinib 560 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
Dose Level 3
n=4 Participants
Ibrutinib 840 mg on Days 1-28,
\> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22
\>
\> Every 28 days
|
|---|---|---|---|
|
Objective Response Rate
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
0 percentage of participants
Interval 0.0 to 63.2
|
25 percentage of participants
Interval 1.3 to 75.1
|
Adverse Events
Dose Level 1 (Starting DL)
Serious events: 6 serious events
Other events: 2 other events
Deaths: 2 deaths
Dose Level 2
Serious events: 3 serious events
Other events: 1 other events
Deaths: 2 deaths
Dose Level 3
Serious events: 4 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Level 1 (Starting DL)
n=6 participants at risk
Ibrutinib 560 mg on Days 1-28, \> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 \>
\> Every 28 days
|
Dose Level 2
n=3 participants at risk
Ibrutinib 560 mg on Days 1-28, \> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 \>
\> Every 28 days
|
Dose Level 3
n=4 participants at risk
Ibrutinib 840 mg on Days 1-28, \> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 \>
\> Every 28 days
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 8 • Up to 34 months
|
100.0%
3/3 • Number of events 6 • Up to 34 months
|
50.0%
2/4 • Number of events 2 • Up to 34 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Eye disorders
Blurred vision
|
33.3%
2/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Eye disorders
Eye pain
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to 34 months
|
66.7%
2/3 • Number of events 2 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
33.3%
1/3 • Number of events 2 • Up to 34 months
|
25.0%
1/4 • Number of events 2 • Up to 34 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 3 • Up to 34 months
|
100.0%
3/3 • Number of events 9 • Up to 34 months
|
25.0%
1/4 • Number of events 2 • Up to 34 months
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Number of events 2 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
25.0%
1/4 • Number of events 2 • Up to 34 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 5 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
General disorders
Edema limbs
|
33.3%
2/6 • Number of events 5 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
General disorders
Facial pain
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 9 • Up to 34 months
|
100.0%
3/3 • Number of events 6 • Up to 34 months
|
50.0%
2/4 • Number of events 2 • Up to 34 months
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
50.0%
2/4 • Number of events 2 • Up to 34 months
|
|
General disorders
Flu like symptoms
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
33.3%
2/6 • Number of events 6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
General disorders
Generalized edema
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
General disorders
Localized edema
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
General disorders
Pain
|
50.0%
3/6 • Number of events 7 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Infections and infestations
Conjunctivitis
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
50.0%
2/4 • Number of events 2 • Up to 34 months
|
|
Infections and infestations
Lip infection
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Infections and infestations
Nail infection
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Infections and infestations
Papulopustular rash
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
2/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Injury, poisoning and procedural complications
Bruising
|
50.0%
3/6 • Number of events 4 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 3 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 4 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 4 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 4 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Investigations
Investigations - Other, specify
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 5 • Up to 34 months
|
66.7%
2/3 • Number of events 5 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 3 • Up to 34 months
|
66.7%
2/3 • Number of events 4 • Up to 34 months
|
75.0%
3/4 • Number of events 5 • Up to 34 months
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
66.7%
2/3 • Number of events 3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
3/6 • Number of events 5 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
3/6 • Number of events 6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
50.0%
2/4 • Number of events 2 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
3/6 • Number of events 3 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
50.0%
2/4 • Number of events 2 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
4/6 • Number of events 6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 3 • Up to 34 months
|
33.3%
1/3 • Number of events 2 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
75.0%
3/4 • Number of events 3 • Up to 34 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Number of events 4 • Up to 34 months
|
33.3%
1/3 • Number of events 2 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
33.3%
2/6 • Number of events 2 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Number of events 7 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 2 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 3 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Psychiatric disorders
Libido decreased
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 2 • Up to 34 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 3 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 3 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
50.0%
2/4 • Number of events 2 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 7 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
1/6 • Number of events 3 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 5 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
33.3%
2/6 • Number of events 2 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
50.0%
3/6 • Number of events 4 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
2/6 • Number of events 3 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
3/6 • Number of events 6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
50.0%
3/6 • Number of events 8 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
Other adverse events
| Measure |
Dose Level 1 (Starting DL)
n=6 participants at risk
Ibrutinib 560 mg on Days 1-28, \> Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 \>
\> Every 28 days
|
Dose Level 2
n=3 participants at risk
Ibrutinib 560 mg on Days 1-28, \> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 \>
\> Every 28 days
|
Dose Level 3
n=4 participants at risk
Ibrutinib 840 mg on Days 1-28, \> Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 \>
\> Every 28 days
|
|---|---|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
33.3%
2/6 • Number of events 3 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 34 months
|
33.3%
1/3 • Number of events 1 • Up to 34 months
|
0.00%
0/4 • Up to 34 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to 34 months
|
0.00%
0/3 • Up to 34 months
|
25.0%
1/4 • Number of events 1 • Up to 34 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place