title: BLT-D (clarithromycin [Biaxin], low-dose thalidomide, and dexamethasone) for the treatment of myeloma and Waldenström's macroglobulinemia.
abstract: Multiple myeloma remains incurable. Despite the pursuit of various chemotherapeutic approaches, little improvement in outcome has been made in the last 30 years. Thalidomide, dexamethasone, and clarithromycin are oral, nonmyelosuppressive agents, each with reported single agent activity against myeloma. We evaluated a regimen of clarithromycin (Biaxin), low-dose thalidomide and dexamethasone (BLT-D) in patients with previously untreated or treated multiple myeloma or Waldenström's macroglobulinemia. Patients were initially given clarithromycin 500 mg twice daily, thalidomide 50-200 mg daily, and dexamethasone 40 mg weekly until disease progression. Minimum response was defined as > 50% reduction in monoclonal immunoglobulin or light chain levels in serum or urine. Response, toxicity, and survival were determined on an evaluable and/or intent-to-treat basis. Of the 50 patients available for analysis, 92% remain alive and 64% remain on treatment with a median and mean duration of treatment of 7 and 8 months, respectively. Overall, 93% of evaluable patients responded to BLT-D, including 13% complete remissions, 40% near complete responses, 13% major responses, and 27% partial responses. Minimal drug resistance was initially encountered. Neurotoxicity, although usually mild to moderate, was the primary reason for treatment discontinuation. Only four patients died, including three sudden deaths in patients with severe cardiopulmonary disease. It appears that BLT-D is a highly effective, nonmyelosuppressive regimen for myeloma. Caution should be exercised when using thalidomide, alone or in combination, in patients with a preexisting tendency to thromboses, severe cardiopulmonary disease, or neurologic dysfunction.
authors.affiliation: Specialized Center of Research for Multiple Myeloma, Weill Medical College of Cornell University and the Department of Medicine, New York Presbyterian Hospital-Cornell Medical Center, New York, NY 10021, USA. mortoncolemanmd@aol.com
authors.forename: Morton
authors.initials: M
authors.lastname: Coleman
authors.forename: John
authors.initials: J
authors.lastname: Leonard
authors.forename: Larry
authors.initials: L
authors.lastname: Lyons
authors.forename: Karen
authors.initials: K
authors.lastname: Pekle
authors.forename: Kenneth
authors.initials: K
authors.lastname: Nahum
authors.forename: Roger
authors.initials: R
authors.lastname: Pearse
authors.forename: Ruben
authors.initials: R
authors.lastname: Niesvizky
authors.forename: Joseph
authors.initials: J
authors.lastname: Michaeli
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007136:Immunoglobulins / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D013792:Thalidomide / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D008258:Waldenstrom Macroglobulinemia / Q000188:drug therapy*
chemical_list: D007136:Immunoglobulins; D013792:Thalidomide; D003907:Dexamethasone; D017291:Clarithromycin