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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003153 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: therapeutic allogeneic lymphocytes |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Estimated Enrollment: | 22 |
| Study Start Date: | February 1998 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet one of following criteria to be considered persistent, recurrent, or progressive disease:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| 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 | Kimmel Cancer Center (KCC) |
More Information
| Study ID Numbers: | CDR0000065938, ECOG-E1A97 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003153 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma |
|
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Recurrence Neoplasms, Plasma Cell Multiple Myeloma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |