Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	Virtual and Standard Colonoscopy Both Accurate Denosumab May Help Prevent Bone Loss Past Highlights

Chemotherapy with BCNU/CTX/PRED vs L-PAM/PRED with FXM/Sodium Fluoride/Calcium Gluconate/Vitamin D for Myeloma

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Supportive care, Treatment

Completed

no age specified

NCI

EST-4472
SEG-343

Objectives

I.  Compare the response rate and survival of a BCNU/CTX/PRED regimen with 
L-PAM/PRED after 6 courses of therapy.
II.  Compare the quality of response obtained by the addition of an ancillary 
regimen of fluoxymesterone, sodium fluoride, calcium gluconate and vitamin D 
with a placebo regimen and vitamin D after 13 months.
III.  Determine the superiority of either regimen in patients who fail to 
improve by crossing over to the other combination after 6 courses.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

All previously treated and untreated 
myeloma patients.

Expected Enrollment

Protocol closed 05/76.

Outline

Randomized study.
Induction:
Arm I:  2-Drug Combination Chemotherapy plus Hormone Therapy.  BCNU, 
NSC-409962; Cyclophosphamide, CTX, NSC-26271; Prednisone, PRED, NSC-10023.
Arm II:  Chemotherapy plus Hormone Therapy.  Melphalan, L-PAM, NSC-8806; PRED.
Maintenance:
Arm III:  Hormone Therapy and Nutritional Therapy.  Fluoxymesterone, FXM, 
NSC-12165; Sodium fluoride, NAFL, NSC-77385; Calcium gluconate, CAGL, and 
Vitamin D (Addendum I, July 1973).
Arm IV:  Placebo and Vitamin D (Addendum I, July 1973).

Published Results

Abramson N, Lurie P, Mietlowski WL, et al.: Phase III study of intermittent carmustine (BCNU), cyclophosphamide, and prednisone versus intermittent melphalan and prednisone in myeloma. Cancer Treat Rep 66 (6): 1273-7, 1982.[PUBMED Abstract]

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.