Overview

Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Multiple Myeloma

Status:
Completed
Trial end date:
2002-09-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with 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 peripheral stem cell transplantation plus combination chemotherapy in treating patients who have multiple myeloma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Maryland Greenebaum Cancer Center
University of Maryland, Baltimore
Treatments:
Carmustine
Cisplatin
Cyclophosphamide
Dexamethasone
Etoposide
Melphalan
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma with no greater than 12
months of prior therapy Bone marrow plasmacytosis at least 30% or protein criteria present
No obvious myelodysplastic changes in the bone marrow No CNS disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (3-4 acceptable if
based solely on bone pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4
million/kg Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 4
times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal:
Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF greater than 50% Pulmonary: FEV1
or FVC at least 50% of predicted DLCO at least 50% of predicted Patients unable to complete
pulmonary function tests must have a CT scan of the chest and acceptable arterial blood
gases of PO2 greater than 70 Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception HIV negative No active infection requiring IV
antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: Prior steroid therapy allowed Radiotherapy: At
least 4 weeks since prior radiotherapy Surgery: Not specified