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Phase II/III L-PAM/PRED/VCR vs VP-16/PRED/ADR for Stage II/III Myeloma (Summary Last Modified 12/89)

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III, Phase II

Treatment

Closed

20 and over

SAFR-CT-MM-2

Objectives

I.  Compare standard reference chemotherapy with 
melphalan/vincristine/prednisone to developmental chemotherapy with 
VP-16213/adriamycin/prednisone in patients with myeloma.
II.  Assess the effect of nonspecific stimulation with the immunomodulator 
Biostim on the quantity of chemotherapy that can be administered.  Objective 
deleted per January 1987 notice.
III.  Determine whether the immunomodulator Biostim has any influence on 
cellular or humoral immunity.  Objective deleted per January 1987 notice.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients with 
myeloma.

Expected Enrollment

The anticipated duration of the study is 3 years.  As of January 1983, 
protocol remains active and patients continue to be admitted.

Outline

Randomized study.  Per January 1987 amendment, because Biostim has been found 
to be without activity, immunomodulation with this agent (Arms IB and IIB) has 
been discontinued.  Patients are now randomized to Arms IA and IIA.
Arm IA:  3-Drug Combination Chemotherapy.  Vincristine, VCR, NSC-67574; 
Melphalan, L-PAM, NSC-8806; Prednisone, PRED, NSC-10023.
Arm IB:  3-Drug Combination Chemotherapy plus Immunomodulation.  VCR; L-PAM; 
PRED; plus Biostim.
Arm IIA:  3-Drug Combination Chemotherapy.  VP-16213, VP-16, NSC-141540; 
Adriamycin, ADR, NSC-123127; PRED.
Arm IIB:  3-Drug Combination Chemotherapy plus Immunomodulation.  ADR; VP-16; 
PRED; plus Biostim.
Salvage Therapy:  3-Drug Combination Chemotherapy.  VAO:  VCR, ADR, 
Dexamethasone, DM, NSC-34521.

Trial Contact Information

Trial Lead Organizations

University of Cape Town School of Medicine

Peter Jacobs, MD, PhD, Protocol chair
Ph: 27-21-799-2569
Email: haematol@icon.co.za

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.