NCT00560391 · OUTCOME
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus Dasatinib in Combination With Revlimid (and Dexamethasone) · Source last updated 2016-08-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure NUMBER
Unit participants
Interval / dispersion Not reported
Time frame 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]) What was measured 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.
Analysis population: All treated participants, participants who received at least 1 dose of dasatinib.
Groups in this outcome 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 6 Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 3 Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 3 Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 6 Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 17
Reported measurements High Calcium; GR 0 at BL, GR 0PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 4 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 4 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 15 Not reported Not reported Not reported Not reported
High Calcium; GR 0 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported
High Calcium; GR 0 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
High Calcium; GR 1 to 2 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported
High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Calcium; GR 0 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported
Low Calcium; GR 0 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 4 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 12 Not reported Not reported Not reported Not reported
Low Calcium; GR 0 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported
Low Calcium; GR 1 to 2 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported
Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported
Low Magnesium; GR 0 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 7 Not reported Not reported Not reported Not reported
Low Magnesium; GR 0 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 6 Not reported Not reported Not reported Not reported
Low Magnesium; GR 0 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported
Low Magnesium; GR 1 to 2 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported
Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Magnesium; GR Not reported at BL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 0 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 8 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 3 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 2 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 6 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL Values in participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg 1 Not reported Not reported Not reported Not reported Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 4
group Id OG001
value 2
group Id OG002
value 3
group Id OG003
value 4
group Id OG004
value 15
title High Calcium; GR 0 at BL, GR 0PBL categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 1
title High Calcium; GR 0 at BL, GR 1 to 2 PBL categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
title High Calcium; GR 0 at BL, GR 3 to 4 PBL categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
title High Calcium; GR 1 to 2 at BL, GR 0 PBL categories measurements
group Id OG000
value 0
group Id OG001
value 1
group Id OG002
value 0
group Id OG003
value 2
group Id OG004
value 1
title High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
title High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL categories measurements
group Id OG000
value 2
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 2
group Id OG004
value 1
title Low Calcium; GR 0 at BL, GR 0 PBL categories measurements
group Id OG000
value 3
group Id OG001
value 2
group Id OG002
value 2
group Id OG003
value 4
group Id OG004
value 12
title Low Calcium; GR 0 at BL, GR 1 to 2 PBL categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 2
title Low Calcium; GR 0 at BL, GR 3 to 4 PBL categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
title Low Calcium; GR 1 to 2 at BL, GR 0 PBL categories measurements
group Id OG000
value 1
group Id OG001
value 1
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 1
title Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 1
title Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL Show more (12 of 28) denoms counts
group Id OG000
value 6
group Id OG001
value 3
group Id OG002
value 3
group Id OG003
value 6
group Id OG004
value 17
units Participants
description 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. groups
description 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).
id OG000
title Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
description 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).
id OG001
title Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
description 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).
id OG002
title Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
description 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).
id OG003
title Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
description 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.
id OG004
title Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
param Type NUMBER
population Description All treated participants, participants who received at least 1 dose of dasatinib.
reporting Status POSTED
time Frame 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])
title Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
type PRIMARY
unit Of Measure participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle