Pharmacokinetic, pharmacodynamic and covariate analysis of subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma

Clinical Pharmacokinetics

Volumn 51, Issue 12, 2012, Pages 823-829

  Moreau, Philippe ^a   Karamanesht, Ievgenii I ^b   Domnikova, Natalia ^c   Kyselyova, Maryna Y ^d   Vilchevska, Kateryna V ^e   Doronin, Vadim A ^f   Schmidt, Alexander ^g   Hulin, Cyrille ^h   Leleu, Xavier ⁱ   Esseltine, Dixie Lee ^j   Venkatakrishnan, Karthik ^j   Skee, Donna ^k   Feng, Huaibao ^k   Girgis, Suzette ^k   Cakana, Andrew ^l   Van De Velde, Helgi ^l   Deraedt, William ^l   Facon, Thierry ⁱ  

^a NANTES UNIVERSITY HOSPITAL   (France)

^b Kiev BMT Centre   (Ukraine)

^c State Novosibirsk Regional Clinical Hospital   (Russian Federation)

^d Crimean Republic Clinical Oncology Dispensary   (Ukraine)

^e STATE INSTITUTION NATIONAL RESEARCH CENTER FOR RADIATION MEDICINE OF THE NATIONAL ACADEMY OF MEDICAL SCIENCES OF UKRAINE   (Ukraine)

^f Hematology Department   (Russian Federation)

^g Russian Research Institute of Hematology and Transfusiology   (Russian Federation)

^h UNIVERSITY HOSPITAL OF NANCY   (France)

ⁱ LILLE UNIVERSITY HOSPITAL   (France)

^j MILLENNIUM PHARMACEUTICALS INC   (United States)

^k JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^l JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB;

ARTICLE; CANCER RECURRENCE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, INTRAVENOUS; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; BORONIC ACIDS; HUMANS; INJECTIONS, SUBCUTANEOUS; MIDDLE AGED; MULTIPLE MYELOMA; PROTEASOME ENDOPEPTIDASE COMPLEX; PYRAZINES; RECURRENCE;

EID: 84872806944     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-012-0010-0     Document Type: Article

References (12)

1. Janssen-Cilag International N.V. VELCADE® (bortezomib): summary of product characteristics. Beerse: Janssen-Cilag International N.V.; 2009.
2. Millennium Pharmaceuticals Inc. VELCADE® (bortezomib) for injection: prescribing information. Rev. 13. Cambridge: Millennium Pharmaceuticals Inc.; 2012.
3. Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12:431-40.
4. Moreau P, Coiteux V, Hulin C, Leleu X, van de Velde H, Acharya M, et al. Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma. Haematologica. 2008;93:1908-11.
5. Greipp PR, San MJ, Durie BG, Crowley JJ, Barlogie B, Blade J, et al. International staging system for multiple myeloma. J Clin Oncol. 2005;23:3412-20.
6. Lightcap ES, McCormack TA, Pien CS, Chau V, Adams J, Elliott PJ. Proteasome inhibition measurements: clinical application. Clin Chem. 2000;46:673-83.
7. Lundin J, Kimby E, Bjorkholm M, Broliden PA, Celsing F, Hjalmar V, et al. Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood. 2002;100:768-73.
8. Quinn DI, Nemunaitis J, Fuloria J, Britten CD, Gabrail N, Yee L, et al. Effect of the cytochrome P450 2C19 inhibitor omeprazole on the pharmacokinetics and safety profile of bortezomib in patients with advanced solid tumours, non-Hodgkin's lymphoma or multiple myeloma. Clin Pharmacokinet. 2009;48:199-209.
9. Venkatakrishnan K, Rader M, Ramanathan RK, Ramalingam S, Chen E, Riordan W, et al. Effect of the CYP3A inhibitor ketoconazole on the pharmacokinetics and pharmacodynamics of bortezomib in patients with advanced solid tumors: a prospective, multicenter, open-label, randomized, two-way crossover drug-drug interaction study. Clin Ther. 2009;31(Pt 2):2444-58.
10. Hellmann A, Rule S, Walewski J, Shpilberg O, Feng H, van de Velde H, et al. Effect of cytochrome P450 3A4 inducers on the pharmacokinetic, pharmacodynamic and safety profiles of bortezomib in patients with multiple myeloma or non-Hodgkin's lymphoma. Clin Pharmacokinet. 2011;50:781-91.
11. Leal TB, Remick SC, Takimoto CH, Ramanathan RK, Davies A, Egorin MJ, et al. Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study. Cancer Chemother Pharmacol. 2011;68:1439-47.
12. LoRusso PM, Venkatakrishnan K, Ramanathan RK, Sarantopoulos J, Mulkerin D, Shibata SI, et al. Pharmacokinetics and safety of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction: phase I NCI Organ Dysfunction Working Group Study NCI-6432. Clin Cancer Res. 2012;18:2954-63.