Effect of pamidronate 30 mg versus 90 mg on physical function in patients with newly diagnosed multiple myeloma (Nordic Myeloma Study Group): A double-blind, randomised controlled trial

The Lancet Oncology

Volumn 11, Issue 10, 2010, Pages 973-982

  Gimsing, Peter ^g   Carlson, Kristina ⁱ   Turesson, Ingemar ^j   Fayers, Peter ^k,l   Waage, Anders ^m   Vangsted, Annette ⁿ   Mylin, Anne ^g   Gluud, Christian ^h   Juliusson, Gunnar ^o   Gregersen, Henrik ^p   Hjorth Hansen, Henrik ^m   Nesthus, Ingerid ^q   Dahl, Inger Marie S ^a   Westin, Jan ^a   Nielsen, Johan Lanng ^b   Knudsen, Lene Meldgaard ⁿ   Ahlberg, Lucia ^o   Hjorth, Martin ^c   Abildgaard, Niels ^d   Andersen, Niels Frost ^b   Linder, Olle ^e   Wisløff, Finn ^f   more..

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b UPPSALA UNIVERSITY   (Sweden)

^c LUND UNIVERSITY HOSPITAL   (Sweden)

^d UNIVERSITY OF ABERDEEN   (United Kingdom)

^e NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Norway)

^f TRONDHEIM UNIVERSITY HOSPITAL   (Norway)

^g GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^h LINKÖPING UNIVERSITY HOSPITAL   (Sweden)

ⁱ AALBORG UNIVERSITY HOSPITAL   (Denmark)

^j HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^k UNIVERSITY HOSPITAL OF NORTH NORWAY   (Norway)

^l SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^m AARHUS UNIVERSITY HOSPITAL   (Denmark)

ⁿ Lidkoping Hospital   (Sweden)

^o ODENSE UNIVERSITY HOSPITAL   (Denmark)

^p ÖREBRO UNIVERSITY HOSPITAL   (Sweden)

^q ULLEVÅL UNIVERSITY HOSPITAL   (Norway)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; MELPHALAN; PAMIDRONIC ACID; PREDNISONE; THALIDOMIDE; VINCRISTINE; ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; BONE DENSITY CONSERVATION AGENT;

ADULT; AGED; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; BONE ATROPHY; BONE DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DENMARK; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG MEGADOSE; FEMALE; FOLLOW UP; FRACTURE; HUMAN; JAW OSTEONECROSIS; MAJOR CLINICAL STUDY; MALE; MORBIDITY; MULTICENTER STUDY; MULTIPLE MYELOMA; NORWAY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SWEDEN; TREATMENT RESPONSE; AUTOTRANSPLANTATION; BONE DISEASES; BONE NECROSIS; CHEMICALLY INDUCED; COMPARATIVE STUDY; COMPLICATION; INTRAVENOUS DRUG ADMINISTRATION; JAW DISEASE; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; PROPORTIONAL HAZARDS MODEL; RADIOGRAPHY; RISK ASSESSMENT; RISK FACTOR; SCANDINAVIA; STEM CELL TRANSPLANTATION; TIME; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE DENSITY CONSERVATION AGENTS; BONE DISEASES; DIPHOSPHONATES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; JAW DISEASES; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MULTIPLE MYELOMA; OSTEONECROSIS; PROPORTIONAL HAZARDS MODELS; QUALITY OF LIFE; RISK ASSESSMENT; RISK FACTORS; SCANDINAVIAN AND NORDIC COUNTRIES; STEM CELL TRANSPLANTATION; TIME FACTORS; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME;

EID: 77957332677     PISSN: 14702045     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1470-2045(10)70198-4     Document Type: Article

References (39)

1. Tian E, Zhan F, Walker R, et al. The role of the Wnt-signalling antagonist DKK1 in the development of osteolytic bone lesions in multiple myeloma. N Engl J Med 2003, 349:2483-2494.
2. Lahtinen R, Laakso M, Palva I, Elomaa I, Virkkunen P Randomised, placebo-controlled multicentre trial of clodronate in multiple myeloma. Lancet 1992, 340:1049-1052.
3. McCloskey EV, MacLennan IC, Drayson MT, Chapman C, Dunn J, Kanis JA A randomized trial of the effect of clodronate on skeletal morbidity in multiple myeloma. Br J Haematol 1998, 100:317-325.
4. Berenson JR, Lichtenstein A, Porter L, et al. Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. N Engl J Med 1996, 334:488-493.
5. Berenson JR, Lichtenstein A, Porter L, et al. Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. J Clin Oncol 1998, 16:593-602.
6. Rosen LS, Gordon D, Kaminski M, et al. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer 2003, 98:1735-1744.
7. Morgan G, Davies F, Gregory W et al., Evaluating the effects of zoledronic acid (ZOL) on overall survival (OS) in patients (Pts) with multiple myeloma (MM): results of the Medical Research Council (MRC) Myeloma IX study. 2010 ASCO Annual Meeting; Chicago, IL, USA; June 4-8, 2010. Abstract 8021.
8. Abildgaard N, Brixen K, Eriksen EF, Kristensen JE, Nielsen JL, Heickendorff L Sequential analysis of biochemical markers of bone resorption and bone densitometry in multiple myeloma. Haematologica 2004, 89:567-577.
9. Terpos E, Politou M, Szydlo R, et al. Autologous stem cell transplantation normalizes abnormal bone remodeling and sRANKL/osteoprotegerin ratio in patients with multiple myeloma. Leukemia 2004, 18:1420-1426.
10. Politou MC, Heath DJ, Rahemtulla A, et al. Serum concentrations of Dickkopf-1 protein are increased in patients with multiple myeloma and reduced after autologous stem cell transplantation. Int J Cancer 2006, 119:1728-1731.
11. Shipman CM, Rogers MJ, Apperley JF, Russell RG, Croucher PI Bisphosphonates induce apoptosis in human myeloma cell lines: a novel anti-tumour activity. Br J Haematol 1997, 98:665-672.
12. Aparicia A, Gardner A, Tu Y, Savage A, Berenson J, Lichetenstein A In vitro cytoreductive effects on multiple myeloma cells induced by bisphosphonates. Leukemia 1998, 12:220-229.
13. Shipman CM, Vanderkerken K, Rogers MJ, et al. The potent bisphosphonate ibandronate does not induce myeloma cell apoptosis in a murine model of established multiple myeloma. Br J Haematol 2000, 111:283-286.
14. Markowitz GS, Appel GB, Fine PL, et al. Collapsing focal segmental glomerulosclerosis following treatment with high-dose pamidronate. J Am Soc Nephrol 2001, 12:1164-1172.
15. Migliorati CA, Schubert MM, Peterson DE, Seneda LM Bisphosphonate-associated osteonecrosis of mandibular and maxillary bone: an emerging oral complication of supportive cancer therapy. Cancer 2005, 104:83-93.
16. Terpos E, Sezer O, Croucher PI, et al. The use of bisphosphonates in multiple myeloma: recommendations of an expert panel on behalf of the European Myeloma Network. Ann Oncol 2009, 20:1303-1317.
17. Mellqvist UH, Lenhoff S, Johnsen HE, et al. Cyclophosphamide plus dexamethasone is an efficient initial treatment before high-dose melphalan and autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: results of a randomized comparison with vincristine, doxorubicin, and dexamethasone. Cancer 2008, 112:129-135.
18. Pocock SJ Clinical trials, a practical approach 1998, John Wiley, Chichester.
19. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-376.
20. Clemons M, Dranitsaris G, Cole D, Gainford MC Too much, too little, too late to start again? Assessing the efficacy of bisphosphonates in patients with bone metastases from breast cancer. Oncologist 2006, 11:227-233.
21. Attal M, Harousseau JL, Leyvraz S, et al. Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood 2006, 108:3289-3294.
22. Wisloff F, Gulbrandsen N Health-related quality of life and patients' perceptions in interferon-treated multiple myeloma patients. Nordic Myeloma Study Group. Acta Oncol 2000, 39:809-813.
23. Campbell MJ, Julious SA, Altman DG Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ 1995, 311:1145-1148.
24. Royston P Multiple imputation of missing values. Stata J 2004, 4:227-241.
25. Carlin JB, Li N, Greenwood P, Coffey C Tools for analyzing multiple imputed datasets. Stata J 2003, 3:226-244.
26. Jacobson JL, Hussein MA, Barlogie B, Durie BG, Crowley JJ A new staging system for multiple myeloma patients based on the Southwest Oncology Group (SWOG) experience 1. Br J Haematol 2003, 122:441-450.
27. Wisloff F, Hjorth M Health-related quality of life assessed before and during chemotherapy predicts for survival in multiple myeloma. Br J Haematol 1997, 97:29-37.
28. Wisloff F, Eika S, Hippe E, et al. Measurement of health-related quality of life in multiple myeloma. Br J Haematol 1996, 92:604-613.
29. Spitzer WO, Dobson AJ, Hall J, et al. Measuring the quality of life of cancer patients: a concise QL-index for use by physicians. J Chronic Dis 1981, 34:585-597.
30. McCloskey EV, Dunn JA, Kanis JA, MacLennan IC, Drayson MT Long-term follow-up of a prospective, double-blind, placebo-controlled randomized trial of clodronate in multiple myeloma. Br J Haematol 2001, 113:1035-1043.
31. Attal M, Harousseau JL, Stoppa AM, et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. N Engl J Med 1996, 335:91-97.
32. Child JA, Morgan GJ, Davies FE, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 2003, 348:1875-1883.
33. Lenhoff S, Hjorth M, Holmberg E, et al. Impact on survival of high-dose therapy with autologous stem cell support in patients younger than 60 years with newly diagnosed multiple myeloma: a population-based study. Blood 2000, 95:7-11.
34. Haaber J, Abildgaard N, Knudsen LM, et al. Myeloma cell expression of 10 candidate genes for osteolytic bone disease. Only overexpression of DKK1 correlates with clinical bone involvement at diagnosis. Br J Haematol 2008, 140:25-35.
35. Zheng Y, Zhou H, Fong-Yee C, Modzelewski JR, Seibel MJ, Dunstan CR Bone resorption increases tumour growth in a mouse model of osteosclerotic breast cancer metastasis. Clin Exp Metastasis 2008, 25:559-567.
36. Mercer RR, Miyasaka C, Mastro AM Metastatic breast cancer cells suppress osteoblast adhesion and differentiation. Clin Exp Metastasis 2004, 21:427-435.
37. Body JJ, Facon T, Coleman RE, et al. A study of the biological receptor activator of nuclear factor-kappaB ligand inhibitor, denosumab, in patients with multiple myeloma or bone metastases from breast cancer. Clin Cancer Res 2006, 12:1221-1228.
38. Sordillo EM, Pearse RN RANK-Fc: a therapeutic antagonist for RANK-L in myeloma. Cancer 2003, 97(3 suppl):802-812.
39. Yaccoby S, Ling W, Zhan F, Walker R, Barlogie B, Shaughnessy JD Antibody-based inhibition of DKK1 suppresses tumor-induced bone resorption and multiple myeloma growth in vivo. Blood 2007, 109:2106-2111.