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 that has been treated for longer than 12 months.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Maryland Greenebaum Cancer Center
University of Maryland, Baltimore

Treatments:

Carmustine
Cisplatin
Cyclophosphamide
Dexamethasone
Etoposide
Gemcitabine
Melphalan
Paclitaxel

Criteria

DISEASE CHARACTERISTICS: Histologically proven multiple myeloma with 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
4,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 4 times
upper limit of normal No active or 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