Alpha-2-interferon/melphalan/prednisone in previously untreated patients with multiple myeloma: a phase I-II trial.
Alpha-2-interferon (IFN) has demonstrable activity in advanced, relapsing, or refractory multiple myeloma. Because of the in vitro synergism between the IFNs and cytotoxic agents, we conducted a trial of 30 previously untreated patients with multiple myeloma utilizing various doses of alpha-2-IFN in combination with standard oral doses of melphalan and prednisone. The combination was well-tolerated without unusual or unexpected toxic effects. The limiting toxicity included dose-related myelosuppression, and alpha-2-IFN induced flu-like symptoms and fatigue. Response was seen in at least as many patients as would be expected with melphalan and prednisone alone. The maximal tolerated dose for a phase II-III trial was 5.0 X 10(6) IU/m2 of alpha-2-IFN in combination with standard doses of melphalan and prednisone. Future trials should utilize this dose of alpha-2-IFN with dose de-escalation according to tolerance.
Cooper
M R
MR
Fefer
A
A
Thompson
J
J
Case
D C
DC
Kempf
R
R
Sacher
R
R
Neefe
J
J
Bickers
J
J
Scarffe
J H
JH
Spiegel
R
R
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage / Q000009:adverse effects; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D010976:Platelet Count / Q000187:drug effects; D011241:Prednisone / Q000008:administration & dosage
D007370:Interferon Type I; D008558:Melphalan; D011241:Prednisone