| Trial ID: | L1578 |
| Source ID: | NCT02158052
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| Associated Drug: |
Tacrolimus
|
| Title: |
Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02158052/results
|
| Conditions: |
Multiple Myeloma|Amyloidosis
|
| Interventions: |
DRUG: Tacrolimus|DRUG: Equine Anti-thymocyte globulin|PROCEDURE: Kidney transplant from a related donor|DRUG: Bone marrow transplant from a related donor|RADIATION: Total body irradiation 400 centigray (200 cGy X 2)
|
| Outcome Measures: |
Primary: Number of Participants Without Renal Allograft Rejection at 6 Months Post-transplant, The Primary Outcome is: the incidence of renal allograft rejection at 6 months post-transplant, 6 Months | Secondary: Anti-Tumor Response Rate, 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., 3 years
|
| Sponsor/Collaborators: |
Sponsor: Massachusetts General Hospital
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
2
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-02
|
| Completion Date: |
2021-06-22
|
| Results First Posted: |
2022-12-13
|
| Last Update Posted: |
2022-12-13
|
| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02158052
|
