Seattle,
Washington
98109
Purpose:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with bone marrow or 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 combination chemotherapy followed by
bone marrow or peripheral stem cell transplantation in treating patients with multiple
myeloma.
Study summary:
OBJECTIVES: I. Assess the toxicity and efficacy at the maximum tolerated dose of busulfan,
melphalan, and thiotepa in patients with multiple myeloma.
OUTLINE: This is a single arm, open label study. Peripheral blood stem cells (PBSC) are
collected and cryopreserved, or bone marrow is harvested and stored, until infusion on day
0. Patients receive oral busulfan every 6 hours on days -8, -7, and -6. Melphalan is
administered by continuous IV infusion over 30 minutes on days -5 and -4. Thiotepa is
administered by continuous IV infusion over 2 hours on days -3 and -2. Patients undergo PBSC
or bone marrow infusion 36-48 hours following the completion of chemotherapy (day 0).
Patients are followed for 100 days posttransplant and every 3 months thereafter.
PROJECTED ACCRUAL: 30 patients will be accrued.
Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed stage II/III multiple myeloma (or have
greater than normal beta-2-microglobulin) meeting the Salmon and Durie criteria Stage I
multiple myeloma must have had prior chemotherapy before undergoing transplantation
PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than
2 mg/dL Renal: Creatinine clearance at least 50 mg/min Cardiovascular: Left ventricular
ejection fraction at least 41% Other: Not pregnant HIV negative
PRIOR CONCURRENT THERAPY: Not specified