title: 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 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 29·5 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.
authors.affiliation: Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
authors.forename: Taimur
authors.initials: T
authors.lastname: Sher
authors.forename: Sikander
authors.initials: S
authors.lastname: Ailawadhi
authors.forename: Kena C
authors.initials: KC
authors.lastname: Miller
authors.forename: Debbie
authors.initials: D
authors.lastname: Manfredi
authors.forename: Margaret
authors.initials: M
authors.lastname: Wood
authors.forename: Wei
authors.initials: W
authors.lastname: Tan
authors.forename: Gregory
authors.initials: G
authors.lastname: Wilding
authors.forename: Myron S
authors.initials: MS
authors.lastname: Czuczman
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Hernandez-Ilizaliturri
authors.forename: Fredrick
authors.initials: F
authors.lastname: Hong
authors.forename: Raman
authors.initials: R
authors.lastname: Sood
authors.forename: Saif
authors.initials: S
authors.lastname: Soniwala
authors.forename: William
authors.initials: W
authors.lastname: Lawrence
authors.forename: Saad
authors.initials: S
authors.lastname: Jamshed
authors.forename: Aisha
authors.initials: A
authors.lastname: Masood
authors.forename: Daniel
authors.initials: D
authors.lastname: Iancu
authors.forename: Kelvin
authors.initials: K
authors.lastname: Lee
authors.forename: Asher
authors.initials: A
authors.lastname: Chanan-Khan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects; D000069286:Bortezomib; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D001897:Boronic Acids; D005938:Glucocorticoids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D004317:Doxorubicin