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PURPOSE: This phase II trial is studying how well giving donor white blood cells works in treating patients with recurrent multiple myeloma who have undergone bone marrow transplantation.
- Assess the response rate of patients with recurrent multiple myeloma after an allogeneic marrow transplant from a genotypically HLA identical sibling donor treated with donor lymphocyte infusions as salvage therapy .
- Evaluate the safety and toxicity of this treatment when used as salvage therapy in these patients.
OUTLINE: Patients receive initial cell dose of donor lymphocytes (CD3+ cells) IV over 15-30 minutes. Patients with rapidly progressive disease may skip the initial cell dose and proceed directly to dose escalation to receive CD3+ cells at a higher cell dose. Patients who achieve complete response to the initial treatment may receive up to 2 additional courses of escalating doses of CD3+ cells 8-12 weeks apart in the absence of unacceptable toxicity. Patients are evaluated at 4 and 8 weeks after each infusion. Patients with disease progression at 8 weeks are retreated at that time. Patients who achieve partial response or stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated.
Patients are followed every 2 weeks for 3 months, once a month for 9 months, and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
therapeutic allogeneic lymphocytes
Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:48-0400
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