Multiple Myeloma Clinical Trial
Official title:
Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis
Verified date | July 2016 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.
Status | Completed |
Enrollment | 32 |
Est. completion date | November 2011 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate - Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: in Complete Remission >2 (second complete remission, third complete remission, etc) or in partial remission - Multiple myeloma: relapsed - Chronic lymphocytic leukemia, Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I-II, having progressed after > 2 chemotherapy regimens, in partial remission. - Acute myelogenous or lymphoblastic leukemia in second or subsequent remission or in first remission with adverse cytogenetic or antecedent hematologic disorder - Chronic myelogenous leukemia in accelerated or second stable phase, or imatinib resistant and not eligible for an ablative transplant - Myelodysplasia, previously treated or not eligible for ablative transplant - Age 18-65 years. - ECOG performance status of 0, 1, or 2. - Lack of 6/6 or 5/6 HLA-matched related, 10/10 matched unrelated donor, or unrelated donor not available within the time frame necessary to perform a potentially curative stem cell transplant. Exclusion Criteria: - Cardiac disease: - symptomatic congestive heart failure or - radionuclide ventriculogram (RVG) or echocardiogram determined left ventricular ejection fraction of < 40%, - active angina pectoris, or - uncontrolled hypertension. - Pulmonary disease: - severe chronic obstructive lung disease, or - symptomatic restrictive lung disease, or - corrected DLCO of < 50% of predicted. - Renal disease: - serum creatinine > 2.0 mg/dl. - Hepatic disease: - serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be elevated greater than 2.0mg/dl), - SGOT or SGPT > 3 x normal. - Neurologic disease: - symptomatic leukoencephalopathy, - active central nervous system (CNS) malignancy or other neuropsychiatric abnormalities believed to preclude transplantation (previous CNS malignancy, presently in complete remission [CR] is not exclusion). - HIV antibody. - Uncontrolled infection. - Pregnancy or breast feeding mother. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease | 2 years | No | |
Secondary | To evaluate the days to neutrophil engraftment and platelet engraftment | 2 years | No | |
Secondary | To evaluate the relapse rate and overall disease free survival | TBD | No |
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