Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02158052|
Recruitment Status : Recruiting
First Posted : June 6, 2014
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Amyloidosis||Drug: Tacrolimus Drug: Anti-thymocyte globulin Procedure: Kidney transplant Drug: Bone marrow transplant from a related donor Radiation: Total body irradiation 400 centigray (200 cGy X 2)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined HLA-Matched Bone Marrow and Kidney Transplantation for Multiple Myeloma or Other Hematologic Disorders With End Stage Renal Disease|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
Single arm combined bone marrow and kidney transplantation
Tacrolimus starting on Day -1
Drug: Anti-thymocyte globulin
20 mg/kg IV on Days -3, -1, +1, +3
Procedure: Kidney transplant
On Day 0 the renal transplant is performed according to standard surgical techniques.
Drug: 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.
Radiation: Total body irradiation 400 centigray (200 cGy X 2)
On transplant day -1
- The primary endpoint is the renal allograft rejection rate at 6 months post-transplant. [ Time Frame: Participants will be followed on an intention-to-treat basis, and data from all enrolled participants will be collected, irrespective of outcome, for the scheduled minimum follow-up period of 3 years. ]
BUN and creatinine will be measured daily while hospitalized, then weekly up to 100 days, then at month 6, and years 1, 1.5, 2, 3.
Renal biopsies will be performed as clinically indicated for suspected rejection
- Assess anti-tumor response rates in patients with hematologic malignancies [ Time Frame: Participants will be followed on an intention-to-treat basis, and data from all enrolled participants will be collected, irrespective of outcome, for the scheduled minimum follow-up period of 3 years. ]
- Bone marrow biopsy and aspirate for patients with hematologic malignancy and prior bone marrow involvement (pre-transplant, Day 100, 6 months, year 1, year 2).
- Quantification of serum and urine M protein and serum free light chain analyses for patients with myeloma (Days 35, 70, 100, month 6, year 1, year 1.5, year 2, year 3).
- Quantitative immunoglobulin analysis (Days 7, 14, 21, 28, 42, 56, 70, 84, 100, month 6, year 1, year 1.5, year 2, year 3).
- Additional disease staging procedures and studies for other hematologic malignancies as clinically indicated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158052
|Contact: Thomas R Spitzer, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Thomas R Spitzer, MD 617-724-1124 firstname.lastname@example.org|