A steroid‐independent regimen of bortezomib, liposomal doxorubicin and thalidomide demonstrate high response rates in newly diagnosed multiple myeloma patients

Abstract

Novel agents have provided new a foundation for multiple myeloma therapies. When combined with other anti-myeloma agents, these compounds significantly enhance clinical efficacy. High-dose steroids are frequently used in anti-myeloma combination regimens; however, the doses employed are often poorly tolerated, especially in patients with concurrent comorbid conditions. We hypothesized that a steroid-independent combination regimen could be developed without significant compromise of efficacy. The availability of such a regimen will be important for patients whose concurrent ailments make them poor candidates for steroid containing anti-myeloma regimens. A phase II single institute, non-randomized clinical trial was conducted to investigate a novel steroid-free three-drug combination of bortezomib (V), pegylated liposomal doxorubicin (D), and thalidomide (T), the VDT regimen. Forty-three newly diagnosed multiple myeloma patients requiring treatment were enrolled on this study. The overall response rate and complete response (CR) + near complete response (nCR) rate was 78% and 35%, respectively. Median time to progression was 29.5 months. Fatigue, rash, neuropathy, constipation and infections were the most common side effects. We concluded that VDT is a tolerable and an effective regimen capable of inducing high response rates and can be employed in patients considered to be poor candidates for steroid-based treatment regimens.

Peripheral neuropathy outcomes and efficacy of subcutaneous bortezomib when combined with thalidomide and dexamethasone in the treatment of multiple myeloma

“…Upon treatment with the VTD combination therapy, a decreased white blood cell count, hemoglobin level and platelet count, and gastrointestinal symptoms were the most common side effects in both groups, but these were not severe in the present study. These data were consistent with previous studies (22,23) and presented additional information about the scBor severity as part of a VTD combination therapy.…”

“…Detailed information with regard to other side effects of bortezomib have been sufficiently documented whether this is administered independently or as part of a combination therapy (18)(19)(20)(21)(22)(23). Upon treatment with the VTD combination therapy, a decreased white blood cell count, hemoglobin level and platelet count, and gastrointestinal symptoms were the most common side effects in both groups, but these were not severe in the present study.…”

Efficacy of Bortezomib as First-Line Treatment for Patients with Multiple Myeloma

“…Along with reduction in the severity of sensory neuropathy, the overall toxicity profile was manageable and no treatment associated deaths. 83 The promising results of such steroid-free regimens need further phase III verification for their clinical efficacy and relatively low toxicity.…”

Review on special emphasis of bortezomib on relapsed/refractory myeloma

“…17 Other trial was shown comparable results of treatment with bortezomib, pegylated doxorubicin and thalidomide combination with 78% ORR, of which 35% achieved CR + nCR. The overall toxicity was manageable without treatment associated death.…”