Overview

High-Dose Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma in First Relapse

Status:
Completed

Trial end date:
2001-05-01

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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining peripheral stem cell transplantation with chemotherapy and radiation therapy may allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus total-body irradiation and peripheral stem cell transplantation in treating patients with multiple myeloma in first relapse.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mayo Clinic

Collaborator:

National Cancer Institute (NCI)

Treatments:

Cobalt
Cyclophosphamide
Melphalan

Criteria

DISEASE CHARACTERISTICS: Multiple myeloma confirmed by bone marrow plasmacytosis and with
measurable M-component in the serum or urine by immunoelectrophoresis or immunofixation No
Stage I myeloma No smoldering multiple myeloma Refractory to or in first relapse following
an initial response to VAD (vincristine/doxorubicin/dexamethasone), with relapse defined as
any of the following: 50% increase above the lowest remission level of serum or urine
M-protein while on therapy 25-50% increase above the lowest remission level of serum or
urine M-protein associated with either: Hypercalcemia (greater than 11 mg/dl) Hb decrease
of 2 g/dl attributable to increasing marrow plasmacytosis Appearance of new lytic lesions
Calcium no greater than 11 mg/dl No myeloma meningitis No plasma cell leukemia

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: ECOG 0-2 Hematopoietic: WBC
greater than 500 (after G-CSF) Platelets greater than 25,000 Hepatic: Bilirubin no greater
than 2.0 mg/dl Renal: Creatinine no greater than 2.0 mg/dl Cardiovascular: No NYHA class
II-IV disease Pulmonary: DLCO at least 50% of predicted FVC at least 75% of predicted FEV1
at least 60% of predicted Other: No uncontrolled infection No active fungal infection No
fever No prior malignancy within 5 years except: Basal cell skin cancer In situ carcinoma
of the cervix No pregnant or nursing women

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological response modifiers allowed
Chemotherapy: No time limit between cytotoxic therapy and protocol treatment Prior
cumulative melphalan dose less than 300 mg Endocrine therapy: Corticosteroids for
hypercalcemia allowed Radiotherapy: Prior radiotherapy allowed Prior pelvic radiotherapy
allowed, but patients with such therapy are unlikely to have adequate PBSC harvested
Surgery: Not specified