Phase III study comparing vincristine, doxorubicin (Adriamycin), and dexamethasone (VAD) chemotherapy with VAD plus recombinant interferon alfa-2 in refractory or relapsed multiple myeloma. An Eastern Cooperative Oncology Group study.
OBJECTIVE
This clinical trial was designed to compare the effectiveness of vincristine, doxorubicin (Adriamycin), and dexamethasone (VAD) with VAD plus interferon alfa-2 in patients with refractory or relapsed multiple myeloma.


METHODS
Between January 1990 and May 1992, 47 eligible patients with multiple myeloma who had failed one prior chemotherapeutic regimen were accrued to a multiinstitutional prospective randomized clinical trial. The trial was halted early because of poor accrual.


RESULTS
After a minimum follow-up of 13 months, the objective overall response rate was 28% (25% in the VAD group, 30% in the VAD plus interferon group). The response duration and overall survival were similar for the two treatment groups, with medians of 3.6 and 8.3 months, respectively. Life-threatening or lethal nonhematologic toxicity was seen in 27%. Interferon did not appear to increase the frequency of toxic responses.


CONCLUSIONS
This study shows no advantage to the use of interferon combined with VAD in refractory or relapsing myeloma. However, the small sample size decreased the statistical power to recognize small differences if present. Moreover, the survival data do not suggest a clear advantage to the administration of vincristine or doxorubicin as a 96-hour infusion compared with results of studies using bolus administration combined with high-dose corticosteroids.
Mayo Clinic, Rochester, Minnesota 55905, USA.
M A
MA
Gertz
L A
LA
Kalish
R A
RA
Kyle
R G
RG
Hahn
D C
DC
Tormey
M M
MM
Oken
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012008:Recurrence; D012074:Remission Induction; D015996:Survival Rate; D014481:United States; D014750:Vincristine / Q000008:administration & dosage
D000903:Antibiotics, Antineoplastic; D018931:Antineoplastic Agents, Hormonal; D000972:Antineoplastic Agents, Phytogenic; D007370:Interferon Type I; D011994:Recombinant Proteins; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin