Phase II study of CLAD (cyclophosphamide, liposomal doxorubicin and dexamethasone) in patients with advanced multiple myeloma and historical comparison to CAD (cyclophosphamide, doxorubicin and dexamethasone)

Hematological Oncology

Volumn 25, Issue 3, 2007, Pages 132-139

  Hutter G ^a   Szelenyi H ^a   Schmittel, A ^a   Siehl, J M ^a   Thiel, E ^a   Keilholz, U ^a,b  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Chanté Campus Benjamin Franklin ^*  (Germany)

Author keywords

Liposomal doxorubicin; Multiple myeloma; Treatment

Indexed keywords

CARMUSTINE; CISPLATIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; ETOPOSIDE; IDARUBICIN; MELPHALAN; PREDNISOLONE; THALIDOMIDE; VINCRISTINE; VINDESINE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BACTERIAL ARTHRITIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DEMOGRAPHY; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG FORMULATION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EMBOLISM; FEBRILE NEUTROPENIA; FEMALE; HEART FAILURE; HUMAN; INFECTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; SIDE EFFECT; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT PLANNING; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; DRUG EVALUATION; FEMALE; HUMANS; LEUKOPENIA; MALE; MIDDLE AGED; MULTIPLE MYELOMA; NEUTROPENIA; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME;

EID: 34848897781     PISSN: 02780232     EISSN: 10991069     Source Type: Journal    
DOI: 10.1002/hon.821     Document Type: Article

References (43)

1. Alexanian R, Haut A, Khan AU, et al. Treatment for multiple myeloma. Combination chemotherapy with different melphalan dose regimens. JAMA 1969; 208: 1680-1685.
2. Alexanian R, Dimopoulos M. The treatment of multiple myeloma. N Engl J Med 1994; 330: 484-489.
3. Bergsagel DE. Melphalan/prednisone versus drug combinations for plasma cell myeloma. Eur J Haematol Suppl 1989; 51: 117-123.
4. Alexanian R, Dimopoulos MA, Delasalle K, et al. Primary dexamethasone treatment of multiple myeloma. Blood 1992; 80: 887-890.
5. Rivers SL, Patno ME. Cyclophosphamide vs melphalan in treatment of plasma cell myeloma. JAMA 1969; 207: 1328-1334.
6. Barlogie B, Smith L, Alexanian R. Effective treatment of advanced multiple myeloma refractory to alkylating agents. N Engl J Med 1984; 310: 1353-1356.
7. Anderson H, Scarffe JH, Ranson M, et al. VAD chemotherapy as remission induction for multiple myeloma. Br J Cancer 1995; 71: 326-330.
8. Myeloma Trialists' Collaborative Group. Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. J Clin Oncol 1998; 16: 3832-3842.
9. Sirohi B, Powles R. Multiple myeloma. The Lancet 2004; 363: 875-887.
10. Szélenyi H, Kreuser ED, Keilholz U, et al. Cyclophosphamide, doxorubicin and dexamethasone (CAD) is a highly effective therapy for patients with advanced multiple myeloma. Ann Oncol 2001; 12: 105-108.
11. Shan K, Lincol M, Young JB. Anthracycline-induced cardiotoxicity. Ann Intern Med 1996; 125: 47-58.
12. Lefrak EA, Pitha J, Rosenheim S, et al. A clinicopathologic analysis of doxorubicin cardiotoxicity. Cancer 1973; 32: 302-314.
13. Bristow MR, Mason JW, Billingham ME, et al. Doxorubicin cardiomyopathy: evaluation by phonocardiography, endomyocardial biopsy and cardiac catheterisation. Ann Intern Med 1978; 88: 168-175.
14. Steinherz LJ, Steinherz PG, Tan CT, et al. Cardiac toxicity 4 to 20 years after completing anthracycline therapy. JAMA 1991; 266: 1672-1677.
15. Dazzi H, Kaufmann K, Follath F. Anthracycline-induced acute cardiotoxicity in adults treated for leukaemia. Analysis of the clinico-pathological aspects of documented acute anthracycline-induced cardiotoxicity in patients treated for acute leukaemia at the University Hospital of Zurich, Switzerland, between 1990 and 1996. Ann Oncol 2001; 12: 963-966.
16. Conley BA, Egorin MJ, Whitacre MY, et al. Phase I and pharmacokinetic trial of liposome-encapsulated doxorubicin. Cancer Chemother Pharmacol 1993; 33: 107-112.
17. Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal doxorubicin: review of animal and human studies. Clin Pharmacokinet 2003; 42: 419-436.
18. Waterhouse DN, Tardi PG, Mayer LD, et al. A comparison of liposomal formulations of doxorubicin with drug administered in free form: changing toxicity profiles. Drug Saf 2001; 24: 903-920.
19. Tan BR, Bartlett NL, Arquette MA, et al. A phase I study of gemcitabine and liposomal doxorubicin (Doxil) given every two weeks in patients with refractory malignancies. Proc Am Soc Clin Oncol 1999; 18: 229.
20. Durie BGM, Salmon SE. A clinical staging system for multiple myeloma. Cancer 1975; 36: 842-854.
21. Blade J, Samson D, Reece D, et al. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for blood and marrow transplant. Br J Haematol 1998; 102: 1115-1123.
22. WHO Handbook for reporting results of cancer treatment. WHO Offset Publications: Geneva, 1979.
23. Zangari M, Saghafifar F, Anaissie E, et al. Activated protein C resistance in the absence of factor V Leiden mutation is a common finding in multiple myeloma and is associated with an increased risk of thrombotic complications. Blood Coagul Fibrinolysis 2002; 13: 187-192.
24. Lyass O, Uziely B, Ben-Yosef R, et al. Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma. Cancer 2000; 89: 1037-1047.
25. Cavo M, Zamagni E, Tosi P, et al. Superiority of thalidomide and dexamethasone over vincristine-doxorubicin dexamethasone (VAD) as primary therapy in preparation for autologous transplantation for multiple myeloma. Blood 2005; 106: 35-39.
26. Presant CA, Klahr C. Adriamycin, 1,3-bis (2-chloroethyl) 1 nitrosourea (BCNU, NSC No. 409962), cyclophosphamide plus prednisone (ABC-P) in melphalanresistant multiple myeloma. Cancer 1978; 42: 1222-1227.
27. Van Dobbenburgh OA, Houwen B,Piersma H, et al. Cyclophosphamide, doxorubicin, prednisone and vindesine combination chemotherapy in melphalan-resistant multiple myleoma. Neth J Med 1984; 27: 25-30.
28. MacLennan IC, Chapman C, Dunn J, et al. Combined chemotherapy with ABCM versus melphalan for treatment of myelomatosis. The medical research council working party for leukaemia in adults. Lancet 1992; 339: 200-205.
29. Ohrling M, Bjorkholm M, Osterborg A, et al. Etoposide, doxorubicin, cyclophosphamide and high-dose betamethasone (EACB) as outpatient salvage therapy for refractory multiple myeloma. Eur J Haematol 1993; 51: 45-49.
30. Adam Z, Elbl L, Vorlicek J, et al. Treatment of refractory multiple myeloma with vincristine, adriamycin, dexamethasone, and with repeated application of cyclophosphamide (C-VAD). Acta Med Austriaca 1994; 21: 111-115.
31. Dimopoulos MA, Weber D, Kantarjian H, et al. HyperCVAD for VAD-resistant multiple myeloma. Am J Hematol 1996; 52: 77-81.
32. Raje N, Powles R, Kulkarni S, et al. A comparison of vincristine and doxorubicin infusional chemotherapy with methylprednisolone (VAMP) with the addition of weekly cyclophosphamide (C-VAMP) as induction treatment followed by autografting in previously untreated myeloma. Br J Haematol 1997; 97: 153-160.
33. Giles FJ, Wickham NR, Rapoport BL, et al. Cyclophosphamide, etoposide, vincristine, adriamycin, and dexamethasone (CEVAD) regimen in refractory multiple myeloma: an International Oncology Study Group (IOSG) phase II protocol. Am J Hematol 2000; 63: 125-130.
34. Lee CK, Barlogie B, Munshi N, et al. DTPACE: an effective, novel combination chemotherapy with thalidomide for previously treated patients with myeloma. J Clin Oncol 2003; 21: 2732-2739.
35. Hussein MA, Wood L, Hsi E, et al. A Phase II trial of pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone combination therapy in newly diagnosed multiple myeloma patients. Cancer 2002; 95: 2160-2168.
36. Dimopoulos MA, Pouli A, Zervas K, et al. Prospective randomized comparison of vincristine, doxorubicin and dexamethasone (VAD) administered as intravenous bolus injection and VAD with liposomal doxorubicin as first-line treatment in multiple myeloma. Ann Oncol 2003; 14: 1039-1044.
37. Rossi JF, Jourdan E, Legouffe E, et al. Intermediate analysis of a prospective randomised comparison of standard VAD protocol (vincristin, doxorubcin and dexamethasone) and pegylated liposomal doxorubicin (doxil/CAELYX) plus dexamethasone as a first-line treatment in multiple myeloma (MM). Blood 2003; 102: 447a (1631).
38. Zervas K, Dimopouls MA, Hatzicharissi E, et al. Primary treatment of multiple myeloma with thalidomide, vincristine, liposomal doxorubicin and dexamethasone (T-VAD doxil): a phase II multicenter study. Ann Oncol 2004; 15: 134-138.
39. Hönemann D, Prince HM, Seymour JF, et al. A phase II study of liposomal doxorubicin, vincristin and dexamethasone in multiple myeloma. Leukemia & Lymphoma 2005; 46(6): 945-948.
40. Rifkin RM, Gregory SA, Mohrbacher A, et al. Pegylated liposomal doxorubicin, vincristin, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristin, and dexamethasone in patients with newly diagnosed multiple myeloma. Cancer 2006; 106: 848-858.
41. Offidani M, Corvatta L, Marconi M, et al. Low dose thalidomide with pegylated liposomal doxorubicin and high dose dexamethasone for relapsed/refractory multiple myeloma: a prospective, multicenter, phase II study. Haematologica 2006; 91(1): 133-136.
42. Garcia-Sanz R, Hernandez JM, Sureda A, et al. Pegylated liposomal doxorubicin, melphalan and prednisone therapy for elderly patients with multiple myeloma. Hematol Oncol 2006; 24(4): 205-211.
43. Offidani M, Corvatta L, Piersantelli MN, et al. Thalidomide, dexamethasone, and pegylated doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. Blood 2006; 108: 2159-2163.