Multiple Myeloma Clinical Trial
Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Summary
RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.
Full Description
OBJECTIVES:
Determine whether autologous peripheral blood stem cell transplantation (PBSCT) followed by non-myeloablative allogeneic PBSCT is associated with no more than 20% treatment-related mortality rates at 6 months in patients with multiple myeloma.
Determine the response rate of patients treated with this regimen.
Determine the percent donor chimerism in patients treated with this regimen.
Determine the rate of graft-vs-host disease in patients treated with this regimen.
Determine the toxic effects of this regimen in these patients.
Determine the disease-free and overall survival of patients treated with this regimen.
Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete.
Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover.
Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover.
Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3, and 6.
After day 120, patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs every 8 weeks.
Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then annually for 15 years.
PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of active multiple myeloma that requires treatment
Durie-Salmon stage I, II, and III
No more than 1 progression after initial therapy
Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR)
No syngeneic donors
Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia)
PATIENT CHARACTERISTICS:
Age:
Under 65
Performance status:
NCI CTC 0-1
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count greater than 500/mm^3
Platelet count greater than 50,000/mm^3
Hepatic:
Bilirubin less than 2 mg/dL
AST less than 3 times upper limit of normal (ULN)
Alkaline phosphatase less than 3 times ULN
Renal:
Creatinine less than 2 mg/dL
Creatinine clearance greater than 40 mL/min
Cardiovascular:
LVEF at least 30% by MUGA scan
Pulmonary:
DLCO greater than 40% of predicted
No symptomatic pulmonary disease
Other:
HIV negative
No uncontrolled diabetes mellitus
No active serious infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 4 weeks since prior chemotherapy
Prior alkylating-agent therapy allowed if no more than 12 months duration
Endocrine therapy:
Not specified
Radiotherapy:
At least 4 weeks since prior radiotherapy
Surgery:
At least 4 weeks since prior surgery
Other:
All prior therapy no more than 18 months duration
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There are 15 Locations for this study
San Francisco California, 94115, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Elkton MD Maryland, 21921, United States
St Louis Missouri, 63110, United States
Voorhees New Jersey, 08043, United States
Buffalo New York, 14263, United States
New York New York, 10029, United States
Chapel Hill North Carolina, 27599, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Pittsburgh Pennsylvania, 15224, United States
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