Comparison of Two Long-Term Chemotherapy Regimens, With or Without Agents to Modify Skeletal Repair, in Multiple Myeloma

• Published in: Blood 1984-03, Vol.63 (3), p.639-648
• Main Authors: Cohen, Harvey Jay, Silberman, Harold R., Tornyos, Karl, Bartolucci, Alfred A., the Southeastern Cancer Study Group (SECSG), for
• Format: Article
• Language: English
• Subjects: Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Bone Neoplasms - diagnostic imaging; Bone Neoplasms - drug therapy; Bone Neoplasms - mortality; Calcium Gluconate - administration & dosage; Carmustine - administration & dosage; Chemotherapy; Clinical Trials as Topic; Cyclophosphamide - administration & dosage; Drug Resistance; Drug Therapy, Combination; Fluoxymesterone - administration & dosage; Humans; Long-Term Care; Medical sciences; Melphalan - administration & dosage; Multiple Myeloma - drug therapy; Multiple Myeloma - mortality; Pharmacology. Drug treatments; Prednisone - administration & dosage; Radiography; Sodium Fluoride - administration & dosage; United States; Vitamin D - administration & dosage
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V63.3.639.639

A randomized controlled trial was initiated in 1972 to compare two chemotherapeutic regimens [1–3-bis (2-chloroethyl) 1-nitrosourea (BCNU), cyclophosphamide, and prednisone versus melphalan and prednisone], to determine whether the two regimens are cross-resistant, and to evaluate the effectiveness of sodium fluoride, vitamin D, calcium gluconate, and fluoxymesterone in the promotion of bone healing. Initial responses (50%) and survival (36 mo median) for patients treated with the two chemotherapeutic regimens were the same. Patients on either regimen who failed to respond after 6 mo had a very low response rate to the alternative regimen (approximately 10%). Initially responding patients were randomly assigned to either an active drug regimen (sodium fluoride, vitamin D, calcium gluconate, fluoxymesterone) or placebo tablets. There was no significant difference in the low percentage of patients demonstrating bone improvement. Thus, the BCNU, cyclophosphamide, prednisone regimen is as effective as melphalan and prednisone. Fluoride, calcium, vitamin D, and androgenic steroids should not be routinely recommended in myeloma, as they seem to add little to effective chemotherapy and may contribute to morbidity.