Overview

Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase III trial to study the effectiveness of melphalan followed by peripheral stem cell transplantation in treating patients who have multiple myeloma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Melphalan
Criteria
DISEASE CHARACTERISTICS:

- Diagnosed active multiple myeloma defined by:

- Lytic disease

- Anemia

- Hypercalcemia

- Secondary renal insufficiency

- More than 400 mg/24 hours of urinary protein excretion

- Symptomatic hyperviscosity

- If previously treated, refractory to no more than 1 regimen

- Primary amyloidosis without subsequent multiple myeloma allowed

- Abnormal renal function allowed if due to primary disease

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- See Disease Characteristics

- Creatinine clearance greater than 50 mL/min if no renal impairment

Cardiovascular:

- No cardiac function that would preclude study

- LVEF greater than 45%

Pulmonary:

- No pulmonary function that would preclude study

- FVC greater than 60% predicted

- DLCO greater than 50% predicted

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No greater than 18 months of prior alkylator exposure

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- See Disease Characteristics

- No more than 3 prior treatment regimens allowed