NCT01782963 · OUTCOME
Response Rate With Respect to Cytogenetic Characteristics
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) · Source last updated 2018-10-31
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
- 2 years
What was measured
Response rate was assessed using the International Myeloma Working Group uniform response criteria. Stringent complete response, Complete Response, Very Good Partial Response, and Partial Response are defined in outcome measure 1.
* MR included participants in whom some, but not all, criteria for PR were fulfilled, providing the remaining criteria satisfied the requirements for MR. Required all of the following:
* ≥25% to ≤ 49% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.
* If present, a 50 to 89% reduction in 24-hour light chain excretion, which still exceeds 200 mg/24 h, for at least two determinations six weeks apart.
* 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for at least six weeks.
* No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).
* Stable Disease: Not meeting the criteria for minimal response or
Groups in this outcome
High Risk Cytogenetics
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
Low Risk Cytogenetics
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
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 |
|---|
| High Risk Cytogenetics | 6 |
|---|
| Low Risk Cytogenetics | 44 |
|---|
Reported measurements
Source class 1
Stringent Complete Response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| High Risk Cytogenetics | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Low Risk Cytogenetics | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| High Risk Cytogenetics | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Low Risk Cytogenetics | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Partial Response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| High Risk Cytogenetics | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Low Risk Cytogenetics | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| High Risk Cytogenetics | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Low Risk Cytogenetics | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimal Response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| High Risk Cytogenetics | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Low Risk Cytogenetics | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| High Risk Cytogenetics | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Low Risk Cytogenetics | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Not evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| High Risk Cytogenetics | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Low Risk Cytogenetics | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- title
- Stringent Complete Response
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 14
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 9
- title
- Very Good Partial Response
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 9
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Minimal Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Not evaluable
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 44
- units
- Participants
- description
- Response rate was assessed using the International Myeloma Working Group uniform response criteria. Stringent complete response, Complete Response, Very Good Partial Response, and Partial Response are defined in outcome measure 1.
* MR included participants in whom some, but not all, criteria for PR were fulfilled, providing the remaining criteria satisfied the requirements for MR. Required all of the following:
* ≥25% to ≤ 49% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.
* If present, a 50 to 89% reduction in 24-hour light chain excretion, which still exceeds 200 mg/24 h, for at least two determinations six weeks apart.
* 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for at least six weeks.
* No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).
* Stable Disease: Not meeting the criteria for minimal response or
- groups
- description
- Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
- id
- OG000
- title
- High Risk Cytogenetics
- description
- Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15
Lenalidomide
Bortezomib
Dexamethasone
- id
- OG001
- title
- Low Risk Cytogenetics
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Response Rate With Respect to Cytogenetic Characteristics
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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