Light-chain (AL) amyloidosis - historical

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? Please go to the main light-chain (AL) amyloidosis regimen page to find other regimens.

2 regimens on this page 2 variants on this page

First-line therapy (including transplant ineligible)

Colchicine monotherapy

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Kyle et al. 1985	NR	Randomized (E-switch-ooc)	MP	Did not meet primary endpoint of OS
Cohen et al. 1987	1976-1983	Non-randomized
Kyle et al. 1997	1982-1992	Phase 3 (C)	1. MP	Inferior OS
			2. Melphalan, Prednisone, Colchicine	Inferior OS

Chemotherapy

• Colchicine (Colcrys) 0.6 mg PO twice per day

Continued indefinitely

References

1. Kyle RA, Greipp PR, Garton JP, Gertz MA. Primary systemic amyloidosis: comparison of melphalan/prednisone versus colchicine. Am J Med. 1985 Dec;79(6):708-16. link to original article PubMed
2. Cohen AS, Rubinow A, Anderson JJ, Skinner M, Mason JH, Libbey C, Kayne H. Survival of patients with primary (AL) amyloidosis: colchicine-treated cases from 1976 to 1983 compared with cases seen in previous years (1961 to 1973). Am J Med. 1987 Jun;82(6):1182-90. link to original article PubMed
3. Kyle RA, Gertz MA, Greipp PR, Witzig TE, Lust JA, Lacy MQ, Therneau TM. A trial of three regimens for primary amyloidosis: colchicine alone, melphalan and prednisone, and melphalan, prednisone, and colchicine. N Engl J Med. 1997 Apr 24;336(17):1202-7. link to original article contains dosing details in manuscript PubMed

Melphalan & Prednisone (MP)

MP: Melphalan & Prednisone

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Kyle et al. 1978	NR	Randomized (E-esc)	Placebo	Longer time on treatment
Kyle et al. 1985	NR	Randomized (E-switch-ooc)	Colchicine	Did not meet primary endpoint of OS
Kyle et al. 1997	1982-1992	Phase 3 (C)	1. Colchicine	Superior OS
			2. Melphalan, Prednisone, Colchicine	Did not meet primary endpoint of OS

Note: some studied divided the doses of melphalan and prednisone; others did not; see individual papers for details.

Chemotherapy

• Melphalan (Alkeran) 0.15 mg/kg/day PO on days 1 to 7

Glucocorticoid therapy

• Prednisone (Sterapred) 0.8 mg/kg/day PO on days 1 to 7

42-day cycles

References

1. Kyle RA, Greipp PR. Primary systemic amyloidosis: comparison of melphalan and prednisone versus placebo. Blood. 1978 Oct;52(4):818-27. link to original article contains dosing details in manuscript PubMed
2. Kyle RA, Greipp PR, Garton JP, Gertz MA. Primary systemic amyloidosis: comparison of melphalan/prednisone versus colchicine. Am J Med. 1985 Dec;79(6):708-16. link to original article contains dosing details in manuscript PubMed
3. Kyle RA, Gertz MA, Greipp PR, Witzig TE, Lust JA, Lacy MQ, Therneau TM. A trial of three regimens for primary amyloidosis: colchicine alone, melphalan and prednisone, and melphalan, prednisone, and colchicine. N Engl J Med. 1997 Apr 24;336(17):1202-7. link to original article contains dosing details in manuscript PubMed