Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified	NCI	SWOG-7927/28 MDAR-377, SWOG-7928

Objectives

I.  Compare the effects of 4 drug combinations for remission induction in 
previously untreated patients with multiple myeloma:  followed by VBAP:  
vincristine/BCNU/adriamycin/prednisone vs. VMCP/levamisole followed by 
VBAP/levamisole vs. VCP:  vincristine/cyclophosphamide/prednisone vs. 
VCP/levamisole.
II.  Evaluate 12 months of Maintenance chemotherapy with VCP with and without 
levamisole vs. similar, previous SWOG therapies.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients previously untreated with 
chemotherapy with measurable disease and objective evidence and symptoms of 
complications of any stage of multiple myeloma.  Asymptomatic patients are 
entered only if they have a confirmed diagnosis and there is evidence of 
increasing tumor mass.  Patients must have an adequate cardiac status.

Expected Enrollment

266 patients will be entered in just over 18 months.  Protocol closed August 
1982.

Outline

Randomized study for Induction only.  Randomize patients to Arms I, II, III 
and IV at the ratio of 1:2:2:2 respectively.
Induction:
Arm I:  Sequential 3-Drug Combination Chemotherapy plus Hormone Therapy.  
VMCP:  Vincristine, VCR, NSC-67574; Melphalan, L-PAM, NSC-8806; 
Cyclophosphamide, CTX, NSC-26271; plus Prednisone, PRED, NSC-10023; followed 
by VBAP:  VCR; BCNU, NSC-409962; Adriamycin, ADR, NSC-123127; plus PRED.
Arm II:  Sequential 3-Drug Combination Chemotherapy, Hormone Therapy plus 
Immunotherapy.  VMCP; plus Levamisole, LEV, NSC-177023; followed by VBAP plus 
LEV.
Induction and Maintenance:
Arm III:  2-Drug Combination Chemotherapy plus Hormone Therapy.  VCP:  VCR; 
CTX; plus PRED.
Arm IV:  2-Drug Combination Chemotherapy plus Hormone Therapy plus 
Immunotherapy.  VCP; plus LEV.

Durie BG, Dixon DO, Carter S, et al.: Improved survival duration with combination chemotherapy induction for multiple myeloma: a Southwest Oncology Group Study. J Clin Oncol 4 (8): 1227-37, 1986.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Coltman, MD, Protocol chair(Contact information may not be current)		Ph: 210-567-2710