Multiple Myeloma Clinical Trial
Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.
Full Description
OBJECTIVES:
Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation (TBI) and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions (DLI).
Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI.
Determine the incidence and extent of graft-versus-host disease, regimen-related toxicity, and engraftment in patients treated with these regimens.
Assess the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28.
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months.
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months.
Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months.
Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of one of the following hematologic malignancies:
Chronic myelogenous leukemia (CML)
First or second chronic phase
Accelerated phase
Acute myelogenous leukemia (AML)
At least second remission
First remission allowed if poor-risk features are present (complex chromosome karyotype, abnormalities of chromosomes, especially 5 or 7, 12p-, +13, +8, t[9:11])
Myelodysplastic syndromes (MDS)
Intermediate- or high-risk disease by the prognostic scoring system
Multiple myeloma (MM)
Hodgkin's lymphoma
Second or greater relapse
First relapse allowed if disease-free interval is less than 1 year
Ineligible for autologous transplantation
Non-Hodgkin's lymphoma (NHL)
Grade III follicular large cell (relapsed after one course of prior chemotherapy)
Diffuse large cell (relapsed after one course of prior chemotherapy)
Mantle cell
Chronic lymphocytic leukemia (CLL)
Relapsed after at least 1 course of prior therapy
Must have 6 out of 6 HLA A-, B-, and DR- identical sibling donor
PATIENT CHARACTERISTICS:
Age
18 to 75 for patients with MM
50 to 75 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL
18 to 49 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL who are considered eligible for an allogeneic bone marrow transplantation (BMT) but do not meet institutional criteria for a standard allogeneic BMT
Performance status
Zubrod 0-2
Life expectancy
At least 6 months
Hematopoietic
Not specified
Hepatic
Bilirubin no greater than 3 mg/dL
Renal
Creatinine no greater than 2 mg/dL
Cardiovascular
LVEF at least 40% by MUGA or echocardiogram
Pulmonary
DLCO at least 50% of predicted
Other
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No recent history of drug or alcohol abuse
No other prior malignancy except basal cell skin cancer
No uncontrolled bacterial, viral, fungal, or parasitic infections
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior autologous transplantation allowed if disease progression occurred
No prior or concurrent tandem autologous transplantation followed by non-myeloablative-allograft protocol
Chemotherapy
See Disease Characteristics
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
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There are 14 Locations for this study
Denver Colorado, 80218, United States
Orlando Florida, 32804, United States
Atlanta Georgia, 30342, United States
Iowa City Iowa, 52242, United States
Kansas City Missouri, 64111, United States
Hackensack New Jersey, 07601, United States
Paterson New Jersey, 07503, United States
Rochester New York, 14642, United States
Portland Oregon, 97239, United States
Nashville Tennessee, 37212, United States
Dallas Texas, 75235, United States
San Antonio Texas, 78229, United States
Richmond Virginia, 23298, United States
Madison Wisconsin, 53792, United States
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