A prospective comparative study of efficacy of lenalidomide plus dexamethasone combination therapy versus VAD (vincristine, doxorubicin and dexamethasone) regimen in the treatment of multiple myeloma
Keywords:Complete remission, Efficacy, Lenalidomide plus Dexamethasone (Len-Dex) regimen, Multiple myeloma, VAD (Vincristine, Doxorubicin and Dexamethasone) regimen
Background: Lenalidomide plus Dexamethasone (Len-Dex) and VAD (Vincristine, Doxorubicin and Dexamethasone) regimen are the two common drug therapies employed in the treatment of Multiple myeloma.
Objectives: To compare the efficacy of Len-Dex versus VAD regimen based on complete remission achieved with treatment in newly diagnosed cases of multiple myeloma in a tertiary care hospital in Kerala.
Methods: Eighty patients (forty in each group) of newly diagnosed cases of multiple myeloma, who were willing to give the informed consent, were included in the study. Patients were allocated by the treating physician to two groups; one group was given Len-Dex (lenalidomide + dexamethasone) regimen and the other VAD (Vincristine, Adriamycin, Dexamethasone) regimen. A total of six cycles were given for both groups. Their baseline investigations and follow up investigations were collected at regular intervals, based on these values, the outcome was classified as partial remission and complete remission and the results were compared and analyzed.
Results: Among the forty patients in each group, 17 (38%) on VAD regimen and 28 (62%) on Len-Dex regimen achieved complete remission. The statistical analysis was done using chi square test (χ2= 6.13, df= 1, p= 0.01) which showed statistically significant difference.
Conclusions: The study showed that the efficacy of Lenalidomide-Dexamethasone (Len-Dex) combination therapy is clearly higher than that of VAD regimen among the study population. The overall efficacy of Len-Dex combination is 70% and that of VAD regimen is only 42.5%.
Kyle RA, Rajkumar SV. Plasmacell disorders. In: Lee Goldman, Richard E Behrman (eds.) Cecil Textbook of Medicine. 16th ed. Philadelphia; 2004:1184-1195.
Kyle RA, Rajkumar SV. Multiple myeloma: N Engl J Med. 2004;351:1860-73.
Smith D. Multiple Myeloma. The use of immunomodulatory drugs and proteasome inhibitors has improved the outlook for patients with myeloma, but myeloma remains an incurable cancer. BMJ 2013;346:f3863.
Nair MK, Varghese C, Krishnan E, Sankaranarayanan.R, Nair B. Survival in multiple myeloma in Kerala; Natl Med J India. 1993 Jan-Feb;6(1):7-10 .
Vekariyaa R, Satadiyaa V, Bavaliyaa M, Shahb S. A case of refractory multiple myeloma: Int J Basic Clin Pharmacol. 2012;1(1):41-42.
Menon P, Patersen G. Multiple Myeloma-Survival Rate Statistics by Hospital. Available from: http://myelomasurvival.com/1/post/2013/07/multiple-myeloma-survival-in-india-by-priya-menon-and-gary-petersen.html. (Accessed on August 2013).
Hallek M, Bergsagel PL, Anderson KC. Multiple Myeloma: Increasing Evidence for a Multistep Transformation Process, Blood. 1998:91:3-21.
Hogan MC, Lee A, Soleberg LA, Thome SD. Unusual presentation of multiple myeloma with unilateral visual loss and numb chin syndrome in a young adult; American Journal of Hematology. 2002;70(1); 55-9.
Stoopler ET, Voql DT, Stadtmauer EA. Medical management update: multiple myeloma: Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007;103(5):599-609.
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;16:3832-42.
Sirohi B, Powles R. Multiple myeloma is a B-cell neoplasm and myeloma cells; Lancet. 2004:363:875-87.
Zepeda VHJ, Martínez VJD. Vincristine, doxorubicin, and dexamethasone or thalidomide plus dexamethasone for newly diagnosed patients with multiple myeloma? European Journal of Hematology. 2006:77:(3):239-44.
Cavo M, Zamagni E, Tosi P. Superiority of thalidomide and dexamethasone over vincristine-doxorubicin-dexamethasone (VAD) as primary therapy in preparation for autologous transplantation for multiple myeloma. 2005;106:35-9.
Richardson PG, Schlossman RL, Weller E. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. 2002;100:3063-7.
Khan AAC, Swaika A, Paulus A, Kumar SK, Mikhael JR, Rajkumar SV, et al. Pomalidomide: The new immunomodulatory agent for the treatment of multiple myeloma. Blood Cancer Journal. 2013;e143.
Zangari M, Tricot G, Zeldis J, Eddlemon P, Saghafifar F, Barlogie B. Results of phase I study of CC-5013 for the treatment of multiple myeloma (mm) patients who relapse after high dose chemotherapy (HDCT). Blood. 2001:775.
Friese CR, Abel GA, Magazu LS. Diagnostic delay and complications for older adults with multiple myeloma, Leukemia Lymphoma. 2009;50(3);392-400.
Rajkumar SV, Hayman SR, Lacy MQ, Dispenzieri A. Combination therapy with lenalidomide plus dexamethasone (REV/DEX) for newly diagnosed myeloma; Blood. 2005;106(13);4050-3.
Amano M, Itoh K, Togawa A. VAD chemotherapy in multiple myeloma; Rinsho Ketsueki. 1990;31(7):917-21.
Reece D, Kouroukis CT, LeBlanc R. Advances in Hematology. Practical Approaches to the Use of Lenalidomide in Multiple Myeloma: A Canadian Consensus; 2012:14.
Gay F, Hayman SR, Lacy MQ, Buadi F, Gertz MA, Kumar S et al. Lenalidomide plus dexamethasone versus thalidomide plus dexamethasone in newly diagnosed multiple myeloma: a comparative analysis of 411 patients. 2010;115(7);1343-50.
Attal M, Harousseau JL, Facon T. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med. 2003;349:2495-502.
Lokhorst HM, Schmidt-Wolf I, Sonneveld P. Thalidomide in induction treatment increases the very good partial response rate before and after high-dose therapy in previously untreated multiple myeloma. Haematologica. 2008;93:124-7.
Richardson P, Jagannath S, Schlossman R. A multi-center, randomized, phase 2 study to evaluate the efficacy and safety of 2 CDC-5013 dose regimens when used alone or in combination with dexamethasone (Dex) for the treatment of relapsed or refractory multiple myeloma (MM). 2003;102:235.
Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011;364:1046-60.
Fayers PM, Palumbo A, Hulin C. Thalidomide for previously untreated elderly patients with multiple myeloma: meta-analysis of 1685 individual patient data from six randomized clinical trials. 2011;118:1239-47.
Rajkumar SV, Jacobus S, Callander NS. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: An open-label randomised controlled trial. Lancet Oncol. 2010;11:29-37.