A phase 1/2 study of lenalidomide with low-dose oral cyclophosphamide and low-dose dexamethasone (RdC) in AL amyloidosis

Blood

Volumn 119, Issue 23, 2012, Pages 5384-5390

  Kastritis, Efstathios ^a   Terpos, Evangelos ^a   Roussou, Maria ^a   Gavriatopoulou, Maria ^a   Pamboukas, Constantinos ^a   Boletis, Ioannis ^a   Marinaki, Smaragda ^a   Apostolou, Theofanis ^a   Nikitas, Nikitas ^a   Gkortzolidis, Georgios ^a   Michalis, Eurydiki ^a   Delimpasi, Sossana ^a   Dimopoulos, Meletios A ^a  

^a UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; BORTEZOMIB; COTRIMOXAZOLE; CYCLOPHOSPHAMIDE; DEXAMETHASONE; GRANULOCYTE COLONY STIMULATING FACTOR; LENALIDOMIDE; LOW MOLECULAR WEIGHT HEPARIN; THALIDOMIDE; TROPONIN T; VALACICLOVIR; WARFARIN;

ADULT; AGED; AMYLOIDOSIS; ANEMIA; ARTICLE; COHORT ANALYSIS; CONSTIPATION; CREATININE BLOOD LEVEL; DEEP VEIN THROMBOSIS; DIARRHEA; DISEASE COURSE; DRUG ACTIVITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEASIBILITY STUDY; FEMALE; FEVER; GLOMERULUS FILTRATION RATE; HUMAN; HYPOCALCEMIA; HYPONATREMIA; HYPOTENSION; INFECTION; INTENTION TO TREAT ANALYSIS; LOW DRUG DOSE; MALE; MULTIPLE CYCLE TREATMENT; MYALGIA; NEUTROPENIA; ORTHOSTATIC HYPOTENSION; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIMARY SYSTEMIC LIGHT CHAIN AMYLOIDOSIS; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; REMISSION; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE;

EID: 84862551010     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2011-12-396903     Document Type: Article

References (29)

1. Merlini G, Seldin DC, Gertz MA. Amyloidosis: pathogenesis and new therapeutic options. J Clin Oncol. 2011;29(14):1924-1933.
2. Comenzo RL. How I treat amyloidosis. Blood. 2009;114(15):3147-3157.
3. Palladini G, Perfetti V, Perlini S, et al. The combination of thalidomide and intermediate-dose dexamethasone is an effective but toxic treatment for patients with primary amyloidosis (AL). Blood. 2005;105(7):2949-2951. (Pubitemid 40446290)
4. Seldin DC, Choufani EB, Dember LM, et al. Tolerability and efficacy of thalidomide for the treatment of patients with light chain-associated (AL) amyloidosis. Clin Lymphoma. 2003;3(4):241-246. (Pubitemid 36416849)
5. Dispenzieri A, Lacy MQ, Rajkumar SV, et al. Poor tolerance to high doses of thalidomide in patients with primary systemic amyloidosis. Amyloid. 2003;10(4):257-261. (Pubitemid 38117510)
6. Kastritis E, Wechalekar AD, Dimopoulos MA, et al. Bortezomib with or without dexamethasone in primary systemic (light chain) amyloidosis. J Clin Oncol. 2010;28(6):1031-1037.
7. Reece DE, Hegenbart U, Sanchorawala V, et al. Efficacy and safety of once-weekly and twice-weekly bortezomib in patients with relapsed systemic AL amyloidosis: results of a phase 1/2 study. Blood. 2011;118(4):865-873.
8. Dispenzieri A, Lacy MQ, Zeldenrust SR, et al. The activity of lenalidomide with or without dexamethasone in patients with primary systemic amyloidosis. Blood. 2007;109(2):465-470. (Pubitemid 46105939)
9. Sanchorawala V, Wright DG, Rosenzweig M, et al. Lenalidomide and dexamethasone in the treatment of AL amyloidosis: results of a phase 2 trial. Blood. 2007;109(2):492-496. (Pubitemid 46105943)
10. Rajkumar SV, Jacobus S, Callander NS, et al. 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(1):29-37.
11. Palumbo A, Falco P, Corradini P, et al. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA - Italian Multiple Myeloma Network. J Clin Oncol. 2007;25(28):4459-4465. (Pubitemid 350063804)
12. Morgan GJ, Schey SA, Wu P, et al. Lenalidomide (Revlimid), in combination with cyclophosphamide and dexamethasone (RCD), is an effective and tolerated regimen for myeloma patients. Br J Haematol. 2007;137(3):268-269. (Pubitemid 46537629)
13. Palladini G, Russo P, Bragotti LZ, et al. A phase II trial of cyclophosphamide, lenalidomide and dexamethasone (CLD) in previously treated patients with AL amyloidosis [abstract]. Blood (ASH Annual Meeting Abstracts). 2009;114(22):2863.
14. Moreau P, Jaccard A, Benboubker L, et al. Lenalidomide in combination with melphalan and dexamethasone in patients with newly diagnosed AL amyloidosis: a multicenter phase 1/2 dose-escalation study. Blood. 2010;116(23):4777-4782.
15. Gertz MA, Comenzo R, Falk RH, et al. Definition of organ involvement and treatment response in immunoglobulin light chain amyloidosis (AL): a consensus opinion from the 10th International Symposium on Amyloid and Amyloidosis, Tours, France, 18-22 April 2004. Am J Hematol. 2005;79(4):319-328. (Pubitemid 41098849)
16. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10(1):1-10. (Pubitemid 19099520)
17. Dispenzieri A, Gertz MA, Kyle RA, et al. Serum cardiac troponins and N-terminal pro-brain natriuretic peptide: a staging system for primary systemic amyloidosis. J Clin Oncol. 2004;22(18):3751-3757. (Pubitemid 41095215)
18. Palladini G, Dispenzieri A, Gertz MAA, et al. Validation of the criteria of response to treatment in AL amyloidosis [abstract]. Blood (ASH Annual Meeting Abstracts). 2010;116(21):1364.
19. Dhodapkar MV, Hussein MA, Rasmussen E, et al. Clinical efficacy of high-dose dexamethasone with maintenance dexamethasone/alpha interferon in patients with primary systemic amyloidosis: results of United States Intergroup Trial Southwest Oncology Group (SWOG) S9628. Blood. 2004;104(12):3520-3526. (Pubitemid 39564422)
20. Kumar S, Hayman SR, Buadi F, et al. A phase II trial of lenalidomide, cyclophosphamide and dexamethasone (RCD) in patients with light chain amyloidosis [abstract]. Blood (ASH Annual Meeting Abstracts). 2009;114(22):3853.
21. Lebovic D, Hoffman J, Levine BM, et al. Predictors of survival in patients with systemic light-chain amyloidosis and cardiac involvement initially ineligible for stem cell transplantation and treated with oral melphalan and dexamethasone. Br J Haematol. 2008;143(3):369-373.
22. Palladini G, Russo P, Lavatelli F, et al. Treatment of patients with advanced cardiac AL amyloidosis with oral melphalan, dexamethasone, and thalidomide. Ann Hematol. 2009;88(4):347-350.
23. Dietrich S, Schonland SO, Benner A, et al. Treatment with intravenous melphalan and dexamethasone is not able to overcome the poor prognosis of patients with newly diagnosed systemic light chain amyloidosis and severe cardiac involvement. Blood. 2010;116(4):522-528.
24. Schonland SO, Bochtler T, Ho AD, Hegenbart U. Efficacy and toxicity of dose-reduced bortezomib/dexamethasone chemotherapy in patients with high risk cardiac light chain amyloidosis (Mayo Clinic stage III) [abstract]. Blood (ASH Annual Meeting Abstracts). 2010;116(21):1960.
25. Kastritis E, Roussou M, Migkou M, et al. Long term follow up of the combination of bortezomib with dexamethasone as initial treatment for AL amyloidosis [abstract]. Blood (ASH Annual Meeting Abstracts). 2010;116(21):3048.
26. Dispenzieri A, Dingli D, Kumar SK, et al. Discordance between serum cardiac biomarker and immunoglobulin-free light-chain response in patients with immunoglobulin light-chain amyloidosis treated with immune modulatory drugs. Am J Hematol. 2010;85(10):757-759.
27. Tapan U, Seldin DC, Finn KT, et al. Increases in B-type natriuretic peptide (BNP) during treatment with lenalidomide in AL amyloidosis. Blood. 2010;116(23):5071-5072.
28. Gibbs SD, De Cruz M, Sattianayagam PT, et al. Transient post chemotherapy rise in NT Pro-BNP in AL amyloidosis: implications for organ response assessment [abstract]. Blood (ASH Annual Meeting Abstracts). 2009;114(22):1791.
29. Specter R, Sanchorawala V, Seldin DC, et al. Kidney dysfunction during lenalidomide treatment for AL amyloidosis. Nephrol Dial Transplant. 2011;26(3):881-886.