TY - JOUR
T1 - A steroid-independent regimen of bortezomib, liposomal doxorubicin and thalidomide demonstrate high response rates in newly diagnosed multiple myeloma patients
AU - Sher, Taimur
AU - Ailawadhi, Sikander
AU - Miller, Kena C.
AU - Manfredi, Debbie
AU - Wood, Margaret
AU - Tan, Wei
AU - Wilding, Gregory
AU - Czuczman, Myron S.
AU - Hernandez-Ilizaliturri, Francisco J.
AU - Hong, Fredrick
AU - Sood, Raman
AU - Soniwala, Saif
AU - Lawrence, William
AU - Jamshed, Saad
AU - Masood, Aisha
AU - Iancu, Daniel
AU - Lee, Kelvin
AU - Chanan-Khan, Asher
PY - 2011/7
Y1 - 2011/7
N2 - Novel agents have provided a new 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 29·5months. 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.
AB - Novel agents have provided a new 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 29·5months. 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.
KW - Clinical trials
KW - Multiple myeloma
KW - Newly diagnosed multiple myeloma
KW - Steroids
KW - Thalidomide
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UR - http://www.scopus.com/inward/citedby.url?scp=79958789571&partnerID=8YFLogxK
U2 - 10.1111/j.1365-2141.2011.08703.x
DO - 10.1111/j.1365-2141.2011.08703.x
M3 - Article
C2 - 21554260
AN - SCOPUS:79958789571
SN - 0007-1048
VL - 154
SP - 104
EP - 110
JO - British journal of haematology
JF - British journal of haematology
IS - 1
ER -