TriangleNCT01813227 · OUTCOME
Overall Response Rate (ORR) of Carfilzomib in Bortezomib naïve and Bortezomib-exposed Relapsed WM
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
- Participants will be evaluated every 28 days (1 cycle) until progression or a maximum of 12 cycles (1 year)
What was measured
The overall response rate (ORR) (rate of patients attaining a Partial Response or a Complete Response). Responses will be based on both serum paraprotein levels by SPEP and bidimensional disease measurements on CT scan for patients with adenopathy/organomegaly/lymphadenopathy. Criteria as per the Recommended Response Criteria for Waldenstrom Macroglobulinemia Complete Response: * Absence of serum monoclonal IgM protein by immunofixation * Normal serum IgM level * Complete resolution of extramedullary disease, i.e., lymphadenopathy and splenomegaly if present at baseline * Morphologically normal bone marrow aspirate and trephine biopsy Partial response (PR) * Monoclonal IgM protein is detectable -≥50% but\<90% reduction in serum IgM level from baseline * Reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at baseline * No new signs or symptoms of active disease
Groups in this outcome
Carfilzomib
Carfilzomib 20 mg/m2 on day 1, 2 then 56 mg/m2 days 8, 9 and 15, 16 over 30 minutes every 28 days. Dexamethasone 4 mg (8 mg if \> 45 mg/m2) orally each day of carfilzomib therapy. If less than a partial remission (PR) after 4 cycles, add rituximab 375 mg/m2 on day 16 of each cycle. Patients who meet the criteria for progression prior to 4 cycles of therapy will have rituximab added to their treatment. For patients receiving rituximab, the carfilzomib dose will be decreased to 27 mg/m2. Patients will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles. Carfilzomib: Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study. Rituximab: If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles. Dexamethasone: weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter.
| Group | Source count |
|---|---|
| Carfilzomib | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib | 85.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 85.7
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- description
- The overall response rate (ORR) (rate of patients attaining a Partial Response or a Complete Response). Responses will be based on both serum paraprotein levels by SPEP and bidimensional disease measurements on CT scan for patients with adenopathy/organomegaly/lymphadenopathy. Criteria as per the Recommended Response Criteria for Waldenstrom Macroglobulinemia Complete Response: * Absence of serum monoclonal IgM protein by immunofixation * Normal serum IgM level * Complete resolution of extramedullary disease, i.e., lymphadenopathy and splenomegaly if present at baseline * Morphologically normal bone marrow aspirate and trephine biopsy Partial response (PR) * Monoclonal IgM protein is detectable -≥50% but\<90% reduction in serum IgM level from baseline * Reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at baseline * No new signs or symptoms of active disease
- groups
- description
- Carfilzomib 20 mg/m2 on day 1, 2 then 56 mg/m2 days 8, 9 and 15, 16 over 30 minutes every 28 days. Dexamethasone 4 mg (8 mg if \> 45 mg/m2) orally each day of carfilzomib therapy. If less than a partial remission (PR) after 4 cycles, add rituximab 375 mg/m2 on day 16 of each cycle. Patients who meet the criteria for progression prior to 4 cycles of therapy will have rituximab added to their treatment. For patients receiving rituximab, the carfilzomib dose will be decreased to 27 mg/m2. Patients will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles. Carfilzomib: Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study. Rituximab: If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles. Dexamethasone: weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter.
- id
- OG000
- title
- Carfilzomib
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Participants will be evaluated every 28 days (1 cycle) until progression or a maximum of 12 cycles (1 year)
- title
- Overall Response Rate (ORR) of Carfilzomib in Bortezomib naïve and Bortezomib-exposed Relapsed WM
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice