TriangleNCT03269136 · OUTCOME
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Micrograms per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
What was measured
Cmax of PF-06863135 was measured in this outcome measure. Total is free and bound drug in the body.
Analysis population: Pharmacokinetic (PK) parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.
Groups in this outcome
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 3 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 6 |
| Part 1: PF-06863135 80 mcg/kg SC | 6 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 4 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 12 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
Reported measurements
Total PF-06863135: Cycle 0 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 0 |
| Part 1: PF-06863135 1 mcg/kg IV | 0 |
| Part 1: PF-06863135 3 mcg/kg IV | 0 |
| Part 1: PF-06863135 10 mcg/kg IV | 0 |
| Part 1: PF-06863135 30 mcg/kg IV | 0 |
| Part 1: PF-06863135 50 mcg/kg IV | 0 |
| Part 1: PF-06863135 80 mcg/kg SC | 0 |
| Part 1: PF-06863135 130 mcg/kg SC | 0 |
| Part 1: PF-06863135 215 mcg/kg SC | 0 |
| Part 1: PF-06863135 360 mcg/kg SC | 0 |
| Part 1: PF-06863135 600 mcg/kg SC | 0 |
| Part 1: PF-06863135 1000 mcg/kg SC | 0 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 10 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 3.639 | 21 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 4.216 | 42 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 2.144 | 96 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 2.277 | 51 | Not reported | Not reported | Not reported |
Total PF-06863135: Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 6 |
| Part 1: PF-06863135 80 mcg/kg SC | 6 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 4 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 11 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00168 and 0.00282. |
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00287 and 0.00439 |
| Part 1: PF-06863135 1 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0122 and 0.0133. |
| Part 1: PF-06863135 3 mcg/kg IV | 0.05363 | 36 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.164 and 0.297. |
| Part 1: PF-06863135 30 mcg/kg IV | 0.6044 | 27 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 0.8725 | 41 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 0.2866 | 46 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 0.9076 | 24 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 1.220 | 25 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 2.568 | 42 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 3.802 | 12 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 3.620 | 53 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 9.927 | 18 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 8.710 | 54 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 5.513 | 141 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 5.814 | 36 | Not reported | Not reported | Not reported |
Total PF-06863135: Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 1 |
| Part 1: PF-06863135 3 mcg/kg IV | 2 |
| Part 1: PF-06863135 10 mcg/kg IV | 1 |
| Part 1: PF-06863135 30 mcg/kg IV | 3 |
| Part 1: PF-06863135 50 mcg/kg IV | 3 |
| Part 1: PF-06863135 80 mcg/kg SC | 5 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 3 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 4 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 4 |
| Part 1C: PF-06863135 + Lenalidomide SC | 1 |
| Part 1D: PF-06863135 + Pomalidomide SC | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.475 and 0.624. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.219. |
| Part 1: PF-06863135 3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.151 and 0.233. |
| Part 1: PF-06863135 10 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.440. |
| Part 1: PF-06863135 30 mcg/kg IV | 0.9924 | 8 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 1.684 | 23 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 0.6904 | 55 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 2.108 | 38 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 3.021 | 24 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 5.748 | 16 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 11.92 | 28 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 12.98 | 26 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 25.74 | 19 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 12.03 | 67 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 16.6. |
| Part 1D: PF-06863135 + Pomalidomide SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 10.8 and 12.0. |
Free PF-06863135: Cycle 0 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 0 |
| Part 1: PF-06863135 1 mcg/kg IV | 0 |
| Part 1: PF-06863135 3 mcg/kg IV | 0 |
| Part 1: PF-06863135 10 mcg/kg IV | 0 |
| Part 1: PF-06863135 30 mcg/kg IV | 0 |
| Part 1: PF-06863135 50 mcg/kg IV | 0 |
| Part 1: PF-06863135 80 mcg/kg SC | 0 |
| Part 1: PF-06863135 130 mcg/kg SC | 0 |
| Part 1: PF-06863135 215 mcg/kg SC | 0 |
| Part 1: PF-06863135 360 mcg/kg SC | 0 |
| Part 1: PF-06863135 600 mcg/kg SC | 0 |
| Part 1: PF-06863135 1000 mcg/kg SC | 0 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 10 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 0.9445 | 59 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 1.087 | 79 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 0.5165 | 83 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 0.8080 | 59 | Not reported | Not reported | Not reported |
Free PF-06863135: Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 6 |
| Part 1: PF-06863135 80 mcg/kg SC | 6 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 4 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 11 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 3 mcg/kg IV | 0.0008828 | 1.23 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0760 and 0.153. |
| Part 1: PF-06863135 30 mcg/kg IV | 0.1851 | 40 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 0.3015 | 75 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 0.09913 | 36 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 0.2479 | 28 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 0.5916 | 47 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 0.8304 | 131 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 0.9875 | 52 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 0.8266 | 66 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 2.088 | 106 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 2.485 | 91 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 1.185 | 90 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 2.150 | 76 | Not reported | Not reported | Not reported |
Free PF-06863135: Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 1 |
| Part 1: PF-06863135 3 mcg/kg IV | 2 |
| Part 1: PF-06863135 10 mcg/kg IV | 1 |
| Part 1: PF-06863135 30 mcg/kg IV | 3 |
| Part 1: PF-06863135 50 mcg/kg IV | 3 |
| Part 1: PF-06863135 80 mcg/kg SC | 5 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 3 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 4 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 4 |
| Part 1C: PF-06863135 + Lenalidomide SC | 1 |
| Part 1D: PF-06863135 + Pomalidomide SC | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000. |
| Part 1: PF-06863135 3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 10 mcg/kg IV | NA | NA | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.103. |
| Part 1: PF-06863135 30 mcg/kg IV | 0.2855 | 37 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 0.2955 | 4 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 0.1794 | 40 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 0.3998 | 41 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | 1.473 | 79 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | 1.605 | 182 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 7.981 | 79 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 3.953 | 156 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 11.00 | 186 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 5.323 | 69 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 2.53. |
| Part 1D: PF-06863135 + Pomalidomide SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 9.65 and 12.1. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG013
- spread
- 21
- value
- 3.639
- group Id
- OG014
- spread
- 42
- value
- 4.216
- group Id
- OG015
- spread
- 96
- value
- 2.144
- group Id
- OG016
- spread
- 51
- value
- 2.277
- denoms
- counts
- 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
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Total PF-06863135: Cycle 0 Day 1
- categories
- measurements
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00168 and 0.00282.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00287 and 0.00439
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0122 and 0.0133.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 36
- value
- 0.05363
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.164 and 0.297.
- group Id
- OG004
- spread
- NA
- value
- NA
- group Id
- OG005
- spread
- 27
- value
- 0.6044
- group Id
- OG006
- spread
- 41
- value
- 0.8725
- group Id
- OG007
- spread
- 46
- value
- 0.2866
- group Id
- OG008
- spread
- 24
- value
- 0.9076
- group Id
- OG009
- spread
- 25
- value
- 1.220
- group Id
- OG010
- spread
- 42
- value
- 2.568
- group Id
- OG011
- spread
- 12
- value
- 3.802
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Total PF-06863135: Cycle 1 Day 1
- categories
- measurements
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.475 and 0.624.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.219.
- group Id
- OG002
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.151 and 0.233.
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.440.
- group Id
- OG004
- value
- NA
- group Id
- OG005
- spread
- 8
- value
- 0.9924
- group Id
- OG006
- spread
- 23
- value
- 1.684
- group Id
- OG007
- spread
- 55
- value
- 0.6904
- group Id
- OG008
- spread
- 38
- value
- 2.108
- group Id
- OG009
- spread
- 24
- value
- 3.021
- group Id
- OG010
- spread
- 16
- value
- 5.748
- group Id
- OG011
- spread
- 28
- value
- 11.92
- group Id
- OG012
- spread
- 26
- value
- 12.98
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Total PF-06863135: Cycle 2 Day 1
- categories
- measurements
- group Id
- OG013
- spread
- 59
- value
- 0.9445
- group Id
- OG014
- spread
- 79
- value
- 1.087
- group Id
- OG015
- spread
- 83
- value
- 0.5165
- group Id
- OG016
- spread
- 59
- value
- 0.8080
- denoms
- counts
- 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
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Free PF-06863135: Cycle 0 Day 1
- categories
- measurements
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 1.23
- value
- 0.0008828
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0760 and 0.153.
- group Id
- OG004
- spread
- NA
- value
- NA
- group Id
- OG005
- spread
- 40
- value
- 0.1851
- group Id
- OG006
- spread
- 75
- value
- 0.3015
- group Id
- OG007
- spread
- 36
- value
- 0.09913
- group Id
- OG008
- spread
- 28
- value
- 0.2479
- group Id
- OG009
- spread
- 47
- value
- 0.5916
- group Id
- OG010
- spread
- 131
- value
- 0.8304
- group Id
- OG011
- spread
- 52
- value
- 0.9875
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Free PF-06863135: Cycle 1 Day 1
- categories
- measurements
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.
- group Id
- OG002
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.103.
- group Id
- OG004
- spread
- NA
- value
- NA
- group Id
- OG005
- spread
- 37
- value
- 0.2855
- group Id
- OG006
- spread
- 4
- value
- 0.2955
- group Id
- OG007
- spread
- 40
- value
- 0.1794
- group Id
- OG008
- spread
- 41
- value
- 0.3998
- group Id
- OG009
- spread
- 79
- value
- 1.473
- group Id
- OG010
- spread
- 182
- value
- 1.605
- group Id
- OG011
- spread
- 79
- value
- 7.981
- group Id
- OG012
- spread
- 156
- value
- 3.953
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Free PF-06863135: Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Cmax of PF-06863135 was measured in this outcome measure. Total is free and bound drug in the body.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG000
- title
- Part 1: PF-06863135 0.1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG001
- title
- Part 1: PF-06863135 0.3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG002
- title
- Part 1: PF-06863135 1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG003
- title
- Part 1: PF-06863135 3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG004
- title
- Part 1: PF-06863135 10 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG005
- title
- Part 1: PF-06863135 30 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG006
- title
- Part 1: PF-06863135 50 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG007
- title
- Part 1: PF-06863135 80 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG008
- title
- Part 1: PF-06863135 130 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG009
- title
- Part 1: PF-06863135 215 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG010
- title
- Part 1: PF-06863135 360 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG011
- title
- Part 1: PF-06863135 600 mcg/kg SC
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.
- reporting Status
- POSTED
- time Frame
- 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
- title
- Part 1: Maximum Observed Concentration (Cmax) of PF-06863135
- type
- SECONDARY
- unit Of Measure
- Micrograms per milliliter
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Preserved source evidence · Not medical advice