Multiple Myeloma Clinical Trial
Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
Full Description
OBJECTIVES:
Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders.
Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients.
Determine the relapse rates with this treatment regimen in those patients with malignant disorders.
Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Acute lymphocytic leukemia (ALL):
Complete remission (CR) 1 - high risk defined as overt CNS involvement or poor cytogenetics (additions, deletions, translocations, or multiple abnormalities)
CR2
Induction failures
Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
Acute myelogenous leukemia (AML):
CR1 - high risk defined as poor cytogenetics (deletions, additions, multiple abnormalities)
CR2
Induction failures
Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
Chronic myelogenous leukemia (CML):
Chronic phase (CP) 1
Accelerated phase/CP2 - patients in blast phase must undergo treatment and achieve a second chronic phase prior to transplant
Chronic lymphocytic leukemia (CLL):
Relapse - any stage; must have received no more than 3 prior regimens
Multiple myeloma:
At diagnosis - primary refractory
Relapse (no more than 2) - sensitive disease
Plasma cell leukemia
Inability to achieve a complete remission after autologous transplant (no older than 40)
Myelodysplasia - all subtypes
Myeloproliferative disorders - patients with poor response to medical therapy or cytogenetic abnormalities
Severe aplastic anemia (SAA):
Very SAA - at diagnosis
SAA - induction therapy
Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch
PATIENT CHARACTERISTICS:
Age:
15 to 50
Performance status:
Karnofsky 80-100%
Life expectancy:
Not specified
Hematopoietic:
See Disease Characteristics
Hepatic:
Bilirubin no greater than 2.0 mg/dL
SGOT and SGPT no greater than 3 times normal
PT/PTT normal
Renal:
Creatinine no greater than 2.0 mg/dL
Creatinine clearance at least 60 mL/min
Cardiovascular:
Left ventricular ejection fraction at least 45%
No myocardial infarction within past 6 months
No uncontrolled arrhythmias
Pulmonary:
FEV1 at least 50%
DLCO at least 50% predicted
Other:
No active serious infection
HIV negative
Not pregnant or nursing
No uncontrolled diabetes mellitus or thyroid disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
Chemotherapy:
See Disease Characteristics
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Tampa Florida, 33612, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.