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Trial Outcomes & Findings for Dasatinib in Combination With Revlimid (and Dexamethasone) (NCT NCT00560391)

NCT ID: NCT00560391

Last Updated: 2016-08-04

Results Overview

The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in \< 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Results posted on

2016-08-04

Participant Flow

Of 39 participants were enrolled in this study, 4 never received treatment due to screening failure. A total of 35 participants received treatment.

Participant milestones

Participant milestones
Measure
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Overall Study
STARTED
6
3
3
6
17
Overall Study
COMPLETED
6
3
3
5
15
Overall Study
NOT COMPLETED
0
0
0
1
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Overall Study
Still on treatment
0
0
0
1
2

Baseline Characteristics

Dasatinib in Combination With Revlimid (and Dexamethasone)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Total
n=35 Participants
Total of all reporting groups
Age, Continuous
66.2 years
STANDARD_DEVIATION 11.75 • n=5 Participants
69.3 years
STANDARD_DEVIATION 4.73 • n=7 Participants
63.0 years
STANDARD_DEVIATION 11.14 • n=5 Participants
69.7 years
STANDARD_DEVIATION 5.92 • n=4 Participants
59.3 years
STANDARD_DEVIATION 8.06 • n=21 Participants
63.4 years
STANDARD_DEVIATION 9.19 • n=10 Participants
Age, Customized
21 - 45 years
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
1 participants
n=21 Participants
1 participants
n=10 Participants
Age, Customized
46 - 65 years
3 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
1 participants
n=4 Participants
13 participants
n=21 Participants
20 participants
n=10 Participants
Age, Customized
66 - 75 years
1 participants
n=5 Participants
2 participants
n=7 Participants
1 participants
n=5 Participants
5 participants
n=4 Participants
3 participants
n=21 Participants
12 participants
n=10 Participants
Age, Customized
>75 years
2 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
0 participants
n=21 Participants
2 participants
n=10 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
7 Participants
n=21 Participants
18 Participants
n=10 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
10 Participants
n=21 Participants
17 Participants
n=10 Participants
Race/Ethnicity, Customized
White
6 participants
n=5 Participants
3 participants
n=7 Participants
3 participants
n=5 Participants
6 participants
n=4 Participants
16 participants
n=21 Participants
34 participants
n=10 Participants
Race/Ethnicity, Customized
Asian
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
1 participants
n=21 Participants
1 participants
n=10 Participants
International Staging System (ISS)
Stage I
1 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
0 participants
n=4 Participants
4 participants
n=21 Participants
6 participants
n=10 Participants
International Staging System (ISS)
Stage II
1 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
3 participants
n=4 Participants
2 participants
n=21 Participants
6 participants
n=10 Participants
International Staging System (ISS)
Stage III
1 participants
n=5 Participants
2 participants
n=7 Participants
0 participants
n=5 Participants
1 participants
n=4 Participants
1 participants
n=21 Participants
5 participants
n=10 Participants
International Staging System (ISS)
Not assessed
3 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
2 participants
n=4 Participants
10 participants
n=21 Participants
18 participants
n=10 Participants
Durie-Salmon Staging System
Stage IA
3 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
1 participants
n=4 Participants
2 participants
n=21 Participants
9 participants
n=10 Participants
Durie-Salmon Staging System
Stage IB
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
0 participants
n=21 Participants
0 participants
n=10 Participants
Durie-Salmon Staging System
Stage IIA
0 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
3 participants
n=4 Participants
3 participants
n=21 Participants
7 participants
n=10 Participants
Durie-Salmon Staging System
Stage IIB
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
0 participants
n=21 Participants
0 participants
n=10 Participants
Durie-Salmon Staging System
Stage IIIA
3 participants
n=5 Participants
2 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
6 participants
n=21 Participants
11 participants
n=10 Participants
Durie-Salmon Staging System
Stage IIIB
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
0 participants
n=4 Participants
0 participants
n=21 Participants
0 participants
n=10 Participants
Durie-Salmon Staging System
Not Assessed
0 participants
n=5 Participants
0 participants
n=7 Participants
0 participants
n=5 Participants
2 participants
n=4 Participants
6 participants
n=21 Participants
8 participants
n=10 Participants
Time from diagnosis to first dosing
4.9 years
n=5 Participants
4.0 years
n=7 Participants
7.5 years
n=5 Participants
5.2 years
n=4 Participants
3.7 years
n=21 Participants
4.4 years
n=10 Participants

PRIMARY outcome

Timeframe: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Population: All treated participants, participants who received at least 1 dose of dasatinib.

The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in \< 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=35 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
RP2D of dasatinib in the combination
140 mg
—
—
—
—
Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
RP2D of lenalidomide in the combination
25 mg
—
—
—
—
Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
RP2D dexamethasone in the combination
40 mg
—
—
—
—

PRIMARY outcome

Timeframe: From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Population: All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)

DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia \>5 days/neutropenic fever;platelet count \<10000mm\^3 on \>1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;\>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of \>=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for \>15 days due to any toxicity related to treatment with the combination.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=4 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants With Dose-limiting Toxicity (DLT)
1 participants
0 participants
0 participants
1 participants
0 participants

PRIMARY outcome

Timeframe: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Population: All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)

The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=4 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone
0 participants
0 participants
0 participants
0 participants
0 participants

PRIMARY outcome

Timeframe: Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Population: All treated participants, participants who received at least 1 dose of dasatinib.

AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
All AEs
6 participants
3 participants
3 participants
6 participants
17 participants
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
Drug-related AEs
6 participants
3 participants
3 participants
6 participants
17 participants
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
All deaths
3 participants
2 participants
0 participants
1 participants
3 participants
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
Deaths within 30 days of last dose
1 participants
1 participants
0 participants
0 participants
2 participants
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
All SAEs
3 participants
2 participants
2 participants
5 participants
9 participants
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
Drug-related SAEs
1 participants
1 participants
1 participants
1 participants
4 participants
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
AEs leading to discontinuation
2 participants
1 participants
1 participants
1 participants
8 participants
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
Drug-related AEs leading to discontinuation
2 participants
0 participants
0 participants
0 participants
7 participants

PRIMARY outcome

Timeframe: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])

Population: All treated participants, participants who received at least 1 dose of dasatinib.

As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=\<LLN(lower limit of normal)-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3:\<2.0-1.0\*10\^9/L; GR4:\<1.0\*10\^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=\<LLN-1.5\*10\^9/L; GR2=\<1.5-1.0\*10\^9/L; GR3:\<1.0-0.5\*10\^9/L; GR4:\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3:\<8.0-6.5g/dL; GR4:\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3:\<50.0-25.0\*10\^9/L; GR4:\<25.0\*10\^9/L. BL=Baseline; PBL=post baseline.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Leukopenia; GR 0 at BL, GR 0 PBL
0 participants
2 participants
0 participants
1 participants
2 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Leukopenia; GR 0 at BL, GR 1 to 2 PBL
1 participants
1 participants
3 participants
2 participants
6 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Leukopenia; GR 0 at BL, GR 3 to 4 PBL
2 participants
0 participants
0 participants
0 participants
3 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Leukopenia; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Leukopenia; GR 1 to 2 at BL, GR 1 to 2 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Leukopenia; GR 1 to 2 at BL, GR 3 to 4 PBL
3 participants
0 participants
0 participants
3 participants
5 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Neutropenia; GR 0 at BL, GR 0 PBL
0 participants
1 participants
0 participants
0 participants
1 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Neutropenia; GR 0 at BL, GR 1 to 2 PBL
2 participants
1 participants
2 participants
3 participants
3 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Neutropenia; GR 0 at BL, GR 3 to 4 PBL
3 participants
1 participants
1 participants
0 participants
8 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Neutropenia; GR 1 to 2 at BL, GR 0
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Neutropenia; GR 1 to 2 at BL, GR 1 to 2 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Neutropenia; GR 1 to 2 at BL, GR 3 to 4 PBL
1 participants
0 participants
0 participants
3 participants
4 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Thrombocytopenia; GR 0 at BL, GR 0 PBL
0 participants
1 participants
0 participants
1 participants
2 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Thrombocytopenia; GR 0 at BL, GR 1 to 2 PBL
3 participants
1 participants
2 participants
3 participants
5 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Thrombocytopenia; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
2 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Thrombocytopenia; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Thrombocytopenia; GR 1 to 2 at BL, GR 1 to 2 PBL
1 participants
0 participants
1 participants
1 participants
3 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Thrombocytopenia; GR 1 to 2 at BL, GR 3 to 4 PBL
2 participants
1 participants
0 participants
1 participants
5 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 0 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 0 at BL, GR 1 to 2 PBL
0 participants
1 participants
1 participants
3 participants
6 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 1 to 2 at BL, GR 1 to 2 PBL
4 participants
1 participants
1 participants
1 participants
5 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 1 to 2 at BL, GR 3 to 4 PBL
1 participants
1 participants
1 participants
1 participants
5 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 3 to 4 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 3 to 4 at BL, GR 1 to 2 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR 3 to 4 at BL, GR 3 to 4 PBL
1 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
Anemia; GR Not reported at BL
0 participants
0 participants
0 participants
1 participants
0 participants

PRIMARY outcome

Timeframe: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])

Population: All treated participants, participants who received at least 1 dose of dasatinib.

Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=\>ULN-2.5\*ULN (upper limit of normal); GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4:\>20.0\*ULN; TB:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN; SC: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. BL=Baseline; PBL=post baseline.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
AST; GR 0 at BL, GR 0 PBL
4 participants
0 participants
2 participants
5 participants
5 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
AST; GR 0 at BL, GR 1 to 2 PBL
2 participants
2 participants
0 participants
0 participants
8 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
AST; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
AST; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
AST; GR 1 to 2 at BL, GR 1 to 2 PBL
0 participants
1 participants
1 participants
1 participants
3 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
AST; GR 1 to 2 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
High ALT; GR 0 at BL, GR 0 PBL
2 participants
1 participants
1 participants
2 participants
5 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
ALT; GR 0 at BL, GR 1 to 2 PBL
4 participants
0 participants
0 participants
3 participants
9 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
ALT; GR 0 at BL, GR 3 to 4 PBL
0 participants
1 participants
1 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
ALT; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
ALT; GR 1 to 2 at BL, GR 1 to 2 PBL
0 participants
1 participants
1 participants
1 participants
2 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
ALT; GR 1 to 2 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
Total Bilirubin; GR 0 at BL, GR 0 PBL
5 participants
1 participants
2 participants
4 participants
13 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
Total Bilirubin; GR 0 at BL, GR 1 to 2 PBL
1 participants
1 participants
1 participants
2 participants
4 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
Total Bilirubin; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
SC; GR 0 at BL, GR 0 PBL
4 participants
1 participants
1 participants
6 participants
12 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
SC; GR 0 at BL, GR 1 to 2 PBL
2 participants
1 participants
2 participants
0 participants
3 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
SC; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
SC; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
SC; GR 1 to 2 at BL, GR 1 to 2 PBL
0 participants
1 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
SC; GR 1 to 2 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants

PRIMARY outcome

Timeframe: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])

Population: All treated participants, participants who received at least 1 dose of dasatinib.

Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: \<LLN - 8.0 mg/dL, GR2: \<8.0 - 7.0 mg/dL, GR3: \<7.0 - 6.0 mg/dL, GR4: \<6.0 mg/dL. Calcium (High): GR1: \>ULN - 11.5 mg/dL, GR2: \>11.5 - 12.5 mg/dL, GR3: \>12.5 - 13.5 mg/dL, GR4: \>13.5 mg/dL. Magnesium (Low): GR1: \<LLN - 1.2 mg/dL, GR2: \<1.2 - 0.9 mg/dL, GR3: \<0.9 - 0.7 mg/dL, GR4: \<0.7 mg/dL. Phosphorus (low): GR1: \<LLN - 2.5 mg/dL, GR2: \<2.5 - 2.0 mg/dL, GR3: \<2.0 - 1.0 mg/dL, GR4: \<1.0 mg/dL. BL=Baseline; PBL=post baseline.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
High Calcium; GR 0 at BL, GR 0PBL
4 participants
2 participants
3 participants
4 participants
15 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
High Calcium; GR 0 at BL, GR 1 to 2 PBL
1 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
High Calcium; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
High Calcium; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL
0 participants
1 participants
0 participants
2 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL
1 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Calcium; GR 0 at BL, GR 0 PBL
2 participants
0 participants
1 participants
2 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Calcium; GR 0 at BL, GR 1 to 2 PBL
3 participants
2 participants
2 participants
4 participants
12 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Calcium; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
2 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Calcium; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL
1 participants
1 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Magnesium; GR 0 at BL, GR 0 PBL
2 participants
1 participants
3 participants
2 participants
7 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Magnesium; GR 0 at BL, GR 1 to 2 PBL
3 participants
2 participants
0 participants
3 participants
6 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Magnesium; GR 0 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Magnesium; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL
1 participants
0 participants
0 participants
1 participants
3 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Magnesium; GR Not reported at BL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 0 at BL, GR 0 PBL
1 participants
0 participants
2 participants
3 participants
8 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL
3 participants
3 participants
0 participants
2 participants
2 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL
1 participants
0 participants
0 participants
1 participants
6 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL
0 participants
0 participants
0 participants
0 participants
1 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL
0 participants
0 participants
1 participants
0 participants
0 participants

SECONDARY outcome

Timeframe: Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Population: All treated participants, participants who received at least 1 dose of dasatinib.

Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component \< 100 mg per 24 hour.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants With Complete Response and Very Good Partial Response
Very good partial response
0 participants
0 participants
0 participants
1 participants
3 participants
Number of Participants With Complete Response and Very Good Partial Response
No response
4 participants
2 participants
1 participants
1 participants
11 participants
Number of Participants With Complete Response and Very Good Partial Response
Not reported
1 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Complete Response and Very Good Partial Response
Response Undetermined
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants With Complete Response and Very Good Partial Response
Complete response
0 participants
0 participants
0 participants
0 participants
0 participants

SECONDARY outcome

Timeframe: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Population: All treated participants, participants who received at least 1 dose of dasatinib.

Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to \<200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants With Partial Response
1 participants
1 participants
2 participants
4 participants
3 participants

SECONDARY outcome

Timeframe: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Population: All treated participants, participants who received at least 1 dose of dasatinib.

Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required.

Outcome measures

Outcome measures
Measure
All Treated Participants
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Number of Participants With Minimal Response
0 participants
0 participants
0 participants
0 participants
0 participants

Adverse Events

Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths

Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Serious events: 9 serious events
Other events: 17 other events
Deaths: 0 deaths

Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
n=6 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Gastrointestinal disorders
Colitis
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Influenza
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Rash
0.00%
0/3
16.7%
1/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Vomiting
0.00%
0/3
16.7%
1/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Metabolism and nutrition disorders
Dehydration
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Vascular disorders
Haemorrhage
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Sepsis
0.00%
0/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Pyrexia
0.00%
0/3
16.7%
1/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Cardiac disorders
Arrhythmia
0.00%
0/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Investigations
Blood viscosity increased
0.00%
0/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
General disorders
Chills
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Headache
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Lower respiratory tract infection
0.00%
0/3
33.3%
2/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Chest pain
0.00%
0/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Pneumonia
33.3%
1/3
16.7%
1/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Pneumonia bacterial
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Diarrhoea
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Cardiac disorders
Myocardial ischaemia
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Neutropenic infection
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Synovial cyst
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Blood and lymphatic system disorders
Anaemia
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Nausea
0.00%
0/3
16.7%
1/6
5.9%
1/17
0.00%
0/6
0.00%
0/3

Other adverse events

Other adverse events
Measure
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=6 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
n=17 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
n=6 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
n=3 participants at risk
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/3
0.00%
0/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Arthralgia
33.3%
1/3
33.3%
2/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Colitis
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Cyst
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Psychiatric disorders
Depression
33.3%
1/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Dizziness
66.7%
2/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Eye disorders
Dry eye
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Dry mouth
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3
16.7%
1/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Ear and labyrinth disorders
Dysacusis
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3
0.00%
0/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Injury, poisoning and procedural complications
Fall
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
General disorders
Effusion
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Influenza
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Mouth ulceration
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Oedema
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Rash
33.3%
1/3
16.7%
1/6
47.1%
8/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Syncope
0.00%
0/3
16.7%
1/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Urinary tract infection
33.3%
1/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Vomiting
0.00%
0/3
16.7%
1/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Cardiac disorders
Angina pectoris
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Bronchitis
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Diverticulitis
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Hair growth abnormal
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Oedema peripheral
33.3%
1/3
16.7%
1/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
33.3%
1/3
0.00%
0/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Sinusitis
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Viral infection
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Abdominal pain
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Abdominal tenderness
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3
16.7%
1/6
41.2%
7/17
0.00%
0/6
0.00%
0/3
General disorders
Chest discomfort
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Ear and labyrinth disorders
Ear pain
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Eye disorders
Eye pain
0.00%
0/3
0.00%
0/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Flatulence
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Vascular disorders
Flushing
0.00%
0/3
0.00%
0/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/3
0.00%
0/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Vascular disorders
Hypotension
0.00%
0/3
0.00%
0/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Psychiatric disorders
Insomnia
0.00%
0/3
33.3%
2/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Eye disorders
Keratitis
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Blood and lymphatic system disorders
Leukopenia
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/3
16.7%
1/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
General disorders
Non-cardiac chest pain
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Pleural effusion
33.3%
1/3
16.7%
1/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
General disorders
Pyrexia
33.3%
1/3
16.7%
1/6
29.4%
5/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Somnolence
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Upper respiratory tract infection
0.00%
0/3
0.00%
0/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Ageusia
33.3%
1/3
33.3%
2/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Psychiatric disorders
Anxiety
0.00%
0/3
16.7%
1/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Investigations
Blood creatinine increased
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Investigations
Body temperature increased
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Cellulitis
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
General disorders
Chills
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Eye disorders
Conjunctivitis
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3
83.3%
5/6
47.1%
8/17
0.00%
0/6
0.00%
0/3
General disorders
Crying
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Feeling abnormal
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Haemorrhoids
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Headache
0.00%
0/3
16.7%
1/6
35.3%
6/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
IIIrd nerve disorder
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Lethargy
33.3%
1/3
16.7%
1/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Lower respiratory tract infection
0.00%
0/3
16.7%
1/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Blood and lymphatic system disorders
Neutropenia
0.00%
0/3
50.0%
3/6
52.9%
9/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Respiratory tract infection
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/3
33.3%
2/6
35.3%
6/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Eye disorders
Vision blurred
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Investigations
White blood cell count decreased
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Cardiac disorders
Angina unstable
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Investigations
Blood alkaline phosphatase increased
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Burning sensation
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Chest pain
0.00%
0/3
0.00%
0/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Dysgeusia
0.00%
0/3
16.7%
1/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Exfoliative rash
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/3
0.00%
0/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/3
33.3%
2/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Psychiatric disorders
Mood swings
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
33.3%
1/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Pain in extremity
33.3%
1/3
0.00%
0/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Peripheral motor neuropathy
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Pneumonia
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Pneumonia bacterial
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Psychiatric disorders
Anger
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Psychiatric disorders
Confusional state
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Diarrhoea
33.3%
1/3
50.0%
3/6
70.6%
12/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Gingival pain
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Herpes simplex
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Vascular disorders
Hypertension
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/3
16.7%
1/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Eye disorders
Lacrimation increased
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Lip dry
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Cardiac disorders
Myocardial ischaemia
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Nail infection
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Injury, poisoning and procedural complications
Subdural haemorrhage
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Vascular disorders
Thrombosis
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Ear and labyrinth disorders
Tinnitus
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Eye disorders
Uveitis
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Investigations
Aspartate aminotransferase increased
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Asthenia
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Eye disorders
Cataract
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Eye disorders
Eye swelling
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
General disorders
Fatigue
66.7%
2/3
66.7%
4/6
82.4%
14/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Hypoaesthesia
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Irritability
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Injury, poisoning and procedural complications
Lip injury
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Psychiatric disorders
Mood altered
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Nasopharyngitis
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Oral herpes
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Cardiac disorders
Palpitations
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Periodontal disease
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Musculoskeletal and connective tissue disorders
Synovial cyst
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Tremor
33.3%
1/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Abdominal distension
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Blood and lymphatic system disorders
Anaemia
100.0%
3/3
50.0%
3/6
47.1%
8/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Blood blister
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Cognitive disorder
0.00%
0/3
0.00%
0/6
11.8%
2/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Constipation
66.7%
2/3
0.00%
0/6
35.3%
6/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Dyspepsia
0.00%
0/3
0.00%
0/6
17.6%
3/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Dysphonia
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Dyspnoea
33.3%
1/3
33.3%
2/6
23.5%
4/17
0.00%
0/6
0.00%
0/3
Investigations
Gamma-glutamyltransferase increased
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Gastrointestinal pain
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Infections and infestations
Gingival infection
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Metabolism and nutrition disorders
Hyperglycaemia
33.3%
1/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
General disorders
Influenza like illness
0.00%
0/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Nausea
33.3%
1/3
33.3%
2/6
58.8%
10/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3
16.7%
1/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Vascular disorders
Phlebitis
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Pruritus
33.3%
1/3
0.00%
0/6
58.8%
10/17
0.00%
0/6
0.00%
0/3
Skin and subcutaneous tissue disorders
Psoriasis
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Nervous system disorders
Restless legs syndrome
33.3%
1/3
0.00%
0/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/3
16.7%
1/6
0.00%
0/17
0.00%
0/6
0.00%
0/3
Gastrointestinal disorders
Tongue ulceration
33.3%
1/3
0.00%
0/6
5.9%
1/17
0.00%
0/6
0.00%
0/3
Investigations
Weight decreased
33.3%
1/3
16.7%
1/6
23.5%
4/17
0.00%
0/6
0.00%
0/3

Additional Information

BMS Study Director

Bristol-Myers Squibb

Results disclosure agreements

  • Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
  • Publication restrictions are in place

Restriction type: OTHER