TriangleNCT00903968 · OUTCOME
Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.
What was measured
Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR) which is a complete disappearance of monoclonal paraprotein based on negative immunofixation on the serum M-component and urine M-component and no evidence of myeloma in bone marrow, Very Good Partial Response (VGPR) defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours, Partial Response (PR) ≥50% reduction in serum M-component or ≥90% reduction urine M-component or urine M-component \<200 mg per 24 hours, Minimal Response (MR) ≥25% reduction in serum or urine M-component, Stable Disease (SD) defined as failure to meet any response criteria, and Progressive Disease (PD) ≥ 25% increase from lowest value reported in serum M-component (absolute ≥0.5 g/dL) and/or urine M-component (absolute ≥200 mg/24 hours).
Analysis population: All participants with measureable disease at baseline and received at least one dose of the study drug were evaluable for response.
Groups in this outcome
Phase I Dose Level 1
Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 2
Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 3
Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 4
Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 5
Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 5B
Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 6
Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
All Phase II Participants
All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase I Dose Level 1 | 3 |
| Phase I Dose Level 2 | 3 |
| Phase I Dose Level 3 | 3 |
| Phase I Dose Level 4 | 3 |
| Phase I Dose Level 5 | 4 |
| Phase I Dose Level 5B | 6 |
| Phase I Dose Level 6 | 3 |
| All Phase II Participants | 33 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5B | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| All Phase II Participants | 1 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5B | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 6 | 1 | Not reported | Not reported | Not reported | Not reported |
| All Phase II Participants | 3 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5B | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| All Phase II Participants | 12 | Not reported | Not reported | Not reported | Not reported |
Minimal Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 4 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5B | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| All Phase II Participants | 4 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Level 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 3 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5B | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 6 | 2 | Not reported | Not reported | Not reported | Not reported |
| All Phase II Participants | 11 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 5B | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I Dose Level 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| All Phase II Participants | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- title
- Complete Response
- 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
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- title
- Very Good Partial Response
- 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
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 12
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 4
- title
- Minimal Response
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 11
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 33
- units
- Participants
- description
- Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR) which is a complete disappearance of monoclonal paraprotein based on negative immunofixation on the serum M-component and urine M-component and no evidence of myeloma in bone marrow, Very Good Partial Response (VGPR) defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours, Partial Response (PR) ≥50% reduction in serum M-component or ≥90% reduction urine M-component or urine M-component \<200 mg per 24 hours, Minimal Response (MR) ≥25% reduction in serum or urine M-component, Stable Disease (SD) defined as failure to meet any response criteria, and Progressive Disease (PD) ≥ 25% increase from lowest value reported in serum M-component (absolute ≥0.5 g/dL) and/or urine M-component (absolute ≥200 mg/24 hours).
- groups
- description
- Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase I Dose Level 1
- description
- Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase I Dose Level 2
- description
- Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
- id
- OG002
- title
- Phase I Dose Level 3
- description
- Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
- id
- OG003
- title
- Phase I Dose Level 4
- description
- Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
- id
- OG004
- title
- Phase I Dose Level 5
- description
- Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
- id
- OG005
- title
- Phase I Dose Level 5B
- description
- Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
- id
- OG006
- title
- Phase I Dose Level 6
- description
- All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
- id
- OG007
- title
- All Phase II Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants with measureable disease at baseline and received at least one dose of the study drug were evaluable for response.
- reporting Status
- POSTED
- time Frame
- Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.
- title
- Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice