Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003153 |
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 |
Drug: 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 |
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.
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:
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) |
Study ID Numbers: | CDR0000065938, ECOG-E1A97 |
Study First Received: | November 1, 1999 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00003153 |
Health Authority: | United States: Federal Government |
refractory multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Recurrence Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |