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Clinical Trials (PDQ®)

Phase III Chemotherapy with MP (L-PAM/PRED) vs VBMCP (VCR/BCNU/L-PAM/CTX/PRED) for Untreated Multiple Myeloma (summary last modified 06/97)

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedno age specifiedNCIEST-2479

Objectives

I.  Compare effects of MP (melphalan/prednisone) vs. VBMCP 
(vincristine/BCNU/melphalan/cyclophosphamide/prednisone) for previously 
untreated multiple myeloma.
II.  Evaluate (based on objective response rate, duration of response, 
toxicity, and survival) whether VBMCP should replace MP as standard therapy 
for previously untreated multiple myeloma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with multiple myeloma 
confirmed by the presence of bone marrow plasmacytosis with at least 10% 
plasma cells or biopsy-proven plasmacytoma plus at least one of following:  
myeloma protein in serum, myeloma protein in urine, or radiologic evidence of 
osteolytic lesions.  Disease must be measurable by serum M-component greater 
than 1.0 gm/100 ml, urine monoclonal light chain excretion greater than 200 
mg/24 hrs, or serially measurable soft tissue plasmacytoma.  Patients must 
have adequate liver function and must not have had prior chemotherapy except 
for prednisone or mithramycin for hypercalcemia.

Expected Enrollment

At least 116 patients will be entered in 2 years; 368 patients have been 
entered as of September 1982.  Protocol closed July 1983 with accrual 
objectives met.

Outline

Randomized study.
Arm I:  Single-agent Chemotherapy plus Hormone Therapy.  Melphalan, L-PAM, 
NSC-8806; plus Prednisone, PRED, NSC-10023.
Arm II:  4-Drug Combination Chemotherapy plus Hormone Therapy.  Vincristine, 
VCR, NSC-67574; BCNU, NSC-409962; L-PAM; Cyclophosphamide, CTX, NSC-26271; 
plus PRED.

Published Results

Oken MM, Harrington DP, Abramson N, et al.: Comparison of melphalan and prednisone with vincristine, carmustine, melphalan, cyclophosphamide, and prednisone in the treatment of multiple myeloma: results of Eastern Cooperative Oncology Group Study E2479. Cancer 79 (8): 1561-7, 1997.[PUBMED Abstract]

Oken MM, Tsiatis A, Abramson N, et al.: Evaluation of intensive (VBMCP) vs standard (MP) therapy for mutiple myeloma. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-802, 203, 1987.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Paul Carbone, MD, Protocol chair (Contact information may not be current)
Ph: 608-265-8047; 800-622-8922
Email: carbone@biostat.wisc.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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