Multiple Myeloma Clinical Trial
Official title:
UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
Status | Terminated |
Enrollment | 5 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Stage II or III non-progressive disease Multiple Myeloma. - CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease. - = 70 years old. - Eligible and willing HLA matched related donor. - Bilirubin <2xULN. - ALT and AST <3xULN. - LVEF > 40%. - Creatinine Clearance >40mL/min. - Pulmonary function DLCO corrected to = 70%. - Minimum performance score of 70%. - Platelet count >130 x103 micro L. - LDH =1.5xULN. - No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity. - No uncontrolled infections. Exclusion Criteria: - Age >70 years old. - Performance status <70%. - Uncontrolled infections or is HIV positive - Prior malignancies that are felt to have a <80% probability of being cured. - Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant. - Prior Allograft - History of rapidly growing disease at diagnosis or at any progression or have MDS. - No eligible and willing HLA matched donor. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama in Birmingham BMT/CT Program Outpatient Clinic | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progressive Free Survival Post Transplant | 100, 180, 365 days post transplant; then yearly until 3 years post transplant | No | |
Secondary | Non-relapse treatment related mortality | Within 100 days post transplant | Yes | |
Secondary | Efficacy of donor lymphocyte infusions required in the treatment of persistent disease and/or early rejection based on chimerism studies. | Post transplant as clinically indicated | No | |
Secondary | Incidence of acute and chronic graft versus host disease | Post transplant | No |
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