SWOG-9321 Melphalan, TBI, and Transplant vs Combo Chemo in Untreated Myeloma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation therapy and kill more cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body irradiation, and peripheral stem cell transplantation with that of combination chemotherapy in treating patients who have previously untreated multiple myeloma.

Conditions

• Multiple Myeloma

Interventions

BIOLOGICAL

recombinant interferon alfa

3 million units/m2 SQ Monday-Wednesday -Friday (3 times a week)

DRUG

carmustine

20 mg/m2 I.V. day 1 q 35 days

DRUG

cyclophosphamide

1.5 g/m2 in 100 ml of D5W, IV intravenously over 1 hour every 3 hour x 3 (total dose 4.5 g/m2)

DRUG

dexamethasone

40 mg/day PO or IVPB days 1-4, 9-12, 17-20 q 5 weeks

DRUG

doxorubicin hydrochloride

10 mg/m2/day continuous 1 - 4 q 5 weeks

DRUG

melphalan

140 mg/m2 is given IV within 30 minutes of constitution on Day -5

DRUG

prednisone

40 mg/m2 PO days 1-7 q 35 days

DRUG

vincristine sulfate

0.5 mg/day continuous 1 - 4 q 5 weeks

PROCEDURE

allogeneic bone marrow transplantation

day 0

PROCEDURE

autologous bone marrow transplantation

day 0

PROCEDURE

peripheral blood stem cell transplantation

day 0

RADIATION

radiation therapy

administered in fractionated doses of 150 cGy, 6 - 10 hours apart bid, on Days -4, -3, -2, and -1 (Total 1,200 cGy)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Cancer and Leukemia Group B

  collaborator NETWORK

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Bart Barlogie, MD · University of Arkansas

• Kenneth C. Anderson, MD · Dana-Farber Cancer Institute

• Robert A. Kyle, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1994-01-31

Primary Completion

2003-10-31

Completion

2006-11-30

Countries

• United States

Study Locations