Light-chain (AL) amyloidosis

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First-Line Therapy (including transplant ineligible)

Lenalidomide

Regimen

• Lenalidomide (Revlimid) 15 mg PO daily on days 1-21
• Dexamethasone (Decadron) 10-20 mg/day from days 1 to 4, 9 to 12, and 17 to 20 every other cycle, added if no response to lenalidomide after the first 3 cycles

28-day cycles x 6 cycles

Supportive medications:

• Aspirin 325 mg PO once daily
• Pantoprazole (Protonix) 40 mg PO once daily

References

1. Sanchorawala V, Wright DG, Rosenzweig M, Finn KT, Fennessey S, Zeldis JB, Skinner M, Seldin DC. Lenalidomide and dexamethasone in the treatment of AL amyloidosis: results of a phase 2 trial. Blood. 2007 Jan 15;109(2):492-6. Epub 2006 Sep 7. PubMed PMID: 16960148.

link to original article contains protocol PubMed

Bortezomib

Regimen

• Bortezomib (Velcade) 1.3 mg/m2 IV on days 1, 8, 15, 22
• Dexamethasone (Decadron) 40 mg PO/IV on days 1, 8, 15, 22; can decrease dose to 20 mg PO/IV days 1, 8, 15, 22 for patients with edema due to CHF or nephrotic syndrome, patients with cardiac involvement, and age over 70 years.

35-day cycle x 8 cycles or until hematologic complete response

Supportive medications:

• Pantoprazole (Protonix) 40 mg PO every day
• Acyclovir 400 mg PO BID

References

1. 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;118(4):865-73.

link to original article contains protocol PubMed

1. Reece DE, Sanchorawala V, Hegenbart U, et al. Weekly and twice-weekly bortezomib in patients with systemic AL amyloidosis: results of a phase 1 dose-escalation study. Blood. 2009;114:1489-1497.

link to original article contains protocol PubMed

Melphalan

Regimen

• Melphalan (Alkeran) 0.22 mg/kg/day for 4 days
• Dexamethasone (Decadron) 40 mg/day for 4 days

28-day cycle for 6-9 cycles

Supportive medications:

• Pantoprazole (Protonix) 40 mg PO every day

References

1. Association of melphalan and high-dose dexamethasone is effective and well tolerated in patients with AL (primary) amyloidosis who are ineligible for stem cell transplantation.

Palladini G, Perfetti V, Obici L, Caccialanza R , Semino A, Adami F, Cavallero G, Rustichelli R, Virga G, Merlini G. Blood. 2004;103:2936–2938 link to original article contains protocol PubMed

VMD

VMD: Velcade, Melphalan, Dexamethasone

Regimen

• Melphalan (Alkeran) 9 mg/m2 PO days 1-4; 6 mg/m2 if serum creatinine > 2.5 mg/dL,
• Bortezomib (Velcade) 1.3 mg/m2 IV days 1, 8, 15, 22; 1.0 mg/m2 if patient has peripheral neuropathy at baseline
• Dexamethasone (Decadron) 40 mg PO/IV days 1, 8, 15, 22; 20 mg if > 70 years of age, peripheral edema, or CHF

4-6 week cycle, maximum of 20 cycles

Supportive medications:

• Pantoprazole (Protonix) 40 mg PO every day
• Acyclovir 400 mg PO BID

References

1. Zonder JA, Sanchorawala V, Snyder RM, Matous J, Terebelo H, Janakiraman N, Mapara MY, Lalo S, Tageja N, Webb C, Monsma D, Sellers C, Abrams J, Gasparetto C. Melphalan and Dexamethasone Plus Bortezomib Induces Hematologic and Organ Responses in AL Amyloidosis with Tolerable Neurotoxicity. Blood (ASH Annual Meeting Abstracts), Nov 2009; 114: 746.