Journal
BLOOD
Volume 119, Issue 23, Pages 5374-5383Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2011-11-392522
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Funding
- MRC
- Biomedical Research Center at the Royal Marsden Hospital
- Leukaemia & Lymphoma Research
- Novartis
- Schering Health Care
- Chugai
- Pharmion
- Celgene
- Ortho Biotech
- OrthoBiotech
- Medical Research Council [G0100132] Funding Source: researchfish
- MRC [G0100132] Funding Source: UKRI
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The Medical Research Council Myeloma IX Trial (ISRCTNG8454111) examined traditional and thalidomide-based induction and maintenance regimens and IV zoledronic acid (ZOL) and oral clodronate (CLO) in 1960 patients with newly diagnosed multiple myeloma. Overall survival (OS) and skeletal-related event (SRE) data have been reported for the overall trial population. The present analysis investigated optimal therapy regimens for different patient populations in Myeloma IX. Patients were assigned to intensive or nonintensive treatment pathways and randomized to induction cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) versus cyclophosphamide, thalidomide, and dexamethasone (CTD; intensive) or melphalan and prednisolone versus attenuated oral CTD (CTDa; nonintensive). Patients were also randomized to ZOL or CLO. In the nonintensive pathway, CTDa produced better responses and lower SRE rates than melphalan and prednisolone. ZOL improved OS compared with CLO independently of sex, stage, or myeloma subtype, most profoundly in patients with baseline bone disease or other SREs. In patients treated for >= 2 years, ZOL improved OS compared with CLO from randomization (median not reached for either; P = .02) and also from first on-study disease progression (median, 34 months for ZOL vs 27 months for CLO; P = .03). Thalidomide-containing regimens had better efficacy than traditional regimens, and ZOL demonstrated greater benefits than CLO. (Blood. 2012;119(23):5374-5383)
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