Doxorubicin and dexamethasone followed by thalidomide and dexamethasone is an effective well tolerated initial therapy for multiple myeloma

Abstract

SummaryAmong the drug combinations designed for the initial treatment of multiple myeloma, none has been unequivocally shown to be superior. However, a regimen leading to a high response rate and a low incidence of adverse events is highly desirable. We report the results of a phase II clinical trial involving 45 patients with Durie-Salmon stage II and III multiple myeloma. Doxorubicin and dexamethasone were given for 2 or 3 months followed by thalidomide and dexamethasone for 2 months (AD-TD regimen) with prophylactic antibiotics and daily aspirin (81 mg/d). Among the 42 patients whose response could be assessed, 38 responded to therapy (90AE5%). The intent-to-treat response rate was 84AE4% with seven complete responses (CR 15AE5%), nine near complete responses (nCR 20AE0%), and 22 partial responses (PR 48AE9%). Two patients had stable disease (4AE4%), and two progression of disease (4AE4%). Normalization of the free light chain ratio after one or two cycles of treatment was highly predictive of achievement of CR or nCR. Patients tolerated the treatment well although five patients developed thromboembolic complications (11%). AD-TD administered with low dose aspirin for deep vein thrombosis prophylaxis was well tolerated and yielded a high response rate with minimal treatment-related morbidity.

International uniform response criteria for multiple myeloma

“…Third, although the serum FLC assay is a very reliable test, it is important to closely monitor laboratory variation. 16 Strict guidelines are required with regard to usage times for the serum FLC assay kits. It should also be noted that serum FLC assay testing might be useful in the prognostic and response evaluation of patients who also have a measurable serum and/or urine M-component in the future, given its recently reported prognostic value in M-gammopathy of undetermined significance (MGUS).…”

Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma

“…17 However, this combination administered to patients who are not candidates for autotransplantation led to results similar to those achieved with conventional chemotherapy. 8 Better results can be obtained when chemotherapeutic agents are added to or administered before 18 the thalidomide-dexamethasone combination. [10][11][12][13] At present, it remains unclear which single or other chemotherapy regimen is the best one to be combined with thalidomidedexamethasone to achieve a higher CR rate associated with an acceptable toxicity.…”

International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders

“…There is one published study in which patients were treated with doxorubicin and dexamethasone for 2 or 3 months followed by thalidomide and dexamethasone for 2 months. 42 The authors found that normalization of the rFLC after one or two cycles of treatment, which occurred in 8 of 37 patients, was significantly associated with the achievement of CR or nCR (Po0.003). The significance of this finding is uncertain because no information about PFS or OS as related to rFLC normalization is provided.…”