TriangleNCT02158052 · OUTCOME
Anti-Tumor Response Rate
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
- 3 years
What was measured
This is measurement is summarized via bone marrow biopsy results and blood assays through 3 years. Anti-tumor response is assessed according to Center for International Blood and Marrow Transplant Research (CIBMTR.org) criteria. For multiple myeloma, based on assessment of serum and urine immunofixation, the presence or absence of soft tissue plasmacytomas and analyses of bone marrow aspirate and biopsy samples, response categories include stringent complete remission (sCR), complete remission (CR), near CR (nCR) very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease (PD). For AL amyloidosis, based on assessment of serum and urine immunofixation and serum free light chain ratio, hematologic response categories include complete response, very good partial response, partial response, no response/stable disease and progressive disease. Organ responses are also assessed according to organ specific criteria.
Analysis population: One bone marrow/kidney recipient was enrolled and treated on this trial.
Groups in this outcome
Bone Marrow and Kidney RECIPIENTS
Single arm combined bone marrow and kidney transplantation Tacrolimus: Tacrolimus starting on Day -1 Equine Anti-thymocyte globulin: 20 mg/kg IV on Days -3, -1, +1, +3 Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Total body irradiation 400 centigray (200 cGy X 2): On transplant day -1
| Group | Source count |
|---|---|
| Bone Marrow and Kidney RECIPIENTS | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bone Marrow and Kidney RECIPIENTS | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- This is measurement is summarized via bone marrow biopsy results and blood assays through 3 years. Anti-tumor response is assessed according to Center for International Blood and Marrow Transplant Research (CIBMTR.org) criteria. For multiple myeloma, based on assessment of serum and urine immunofixation, the presence or absence of soft tissue plasmacytomas and analyses of bone marrow aspirate and biopsy samples, response categories include stringent complete remission (sCR), complete remission (CR), near CR (nCR) very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease (PD). For AL amyloidosis, based on assessment of serum and urine immunofixation and serum free light chain ratio, hematologic response categories include complete response, very good partial response, partial response, no response/stable disease and progressive disease. Organ responses are also assessed according to organ specific criteria.
- groups
- description
- Single arm combined bone marrow and kidney transplantation Tacrolimus: Tacrolimus starting on Day -1 Equine Anti-thymocyte globulin: 20 mg/kg IV on Days -3, -1, +1, +3 Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Total body irradiation 400 centigray (200 cGy X 2): On transplant day -1
- id
- OG000
- title
- Bone Marrow and Kidney RECIPIENTS
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One bone marrow/kidney recipient was enrolled and treated on this trial.
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- Anti-Tumor Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice