NCT02990338 · OUTCOME
Percentage of Participants With Best Overall Response (BOR) as Per Independent Response Committee
Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
What was measured
BOR:best sequential response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response (MR), stable disease (SD), PD, and not evaluable.CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,\<5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,\>=90% reduction in serum M-protein plus urine M-protein level \<100mg/24h,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: \>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by \>=90%/\<200mg/24h. MR:\>=25% but \<=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.
Analysis population: Analysis was performed on ITT population.
Groups in this outcome
Pd (Pomalidomide + Dexamethasone)
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
IPd (Isatuximab + Pomalidomide + Dexamethasone)
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
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 |
|---|
| Pd (Pomalidomide + Dexamethasone) | 153 |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 154 |
|---|
Reported measurements
Stringent complete response
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 0.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete response
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 1.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Very good partial response
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 6.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 27.3 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial response
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 26.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 28.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimal response
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 11.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 6.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable disease
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 29.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 21.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 9.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 3.9 | Not reported | Not reported | Not reported | Not reported |
|---|
Not evaluable
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pd (Pomalidomide + Dexamethasone) | 10.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| IPd (Isatuximab + Pomalidomide + Dexamethasone) | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.7
- group Id
- OG001
- value
- 0
- title
- Stringent complete response
- categories
- measurements
- group Id
- OG000
- value
- 1.3
- group Id
- OG001
- value
- 4.5
- title
- Complete response
- categories
- measurements
- group Id
- OG000
- value
- 6.5
- group Id
- OG001
- value
- 27.3
- title
- Very good partial response
- categories
- measurements
- group Id
- OG000
- value
- 26.8
- group Id
- OG001
- value
- 28.6
- title
- Partial response
- categories
- measurements
- group Id
- OG000
- value
- 11.1
- group Id
- OG001
- value
- 6.5
- title
- Minimal response
- categories
- measurements
- group Id
- OG000
- value
- 29.4
- group Id
- OG001
- value
- 21.4
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 9.2
- group Id
- OG001
- value
- 3.9
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 10.5
- group Id
- OG001
- value
- 4.5
- title
- Not evaluable
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- BOR:best sequential response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response (MR), stable disease (SD), PD, and not evaluable.CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,\<5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,\>=90% reduction in serum M-protein plus urine M-protein level \<100mg/24h,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: \>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by \>=90%/\<200mg/24h. MR:\>=25% but \<=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.
- groups
- description
- Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
- id
- OG000
- title
- Pd (Pomalidomide + Dexamethasone)
- description
- Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
- id
- OG001
- title
- IPd (Isatuximab + Pomalidomide + Dexamethasone)
- param Type
- NUMBER
- population Description
- Analysis was performed on ITT population.
- reporting Status
- POSTED
- time Frame
- From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
- title
- Percentage of Participants With Best Overall Response (BOR) as Per Independent Response Committee
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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