Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
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|ClinicalTrials.gov Identifier: NCT00003153|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 1, 2019
RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with multiple myeloma that has recurred following bone marrow transplantation.
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: therapeutic allogeneic lymphocytes||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Official Title:||Phase II Study of Salvage Cellular Immunotherapy for Patients With Persistent or Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation From an HLA-Matched Sibling Donor|
|Actual Study Start Date :||February 1998|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||May 1, 2009|
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): NCT00003153
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226-3596|
|Study Chair:||Neal Flomenberg, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|