Difference between revisions of "Light-chain (AL) amyloidosis - historical"

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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 [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? Please go to the [[Light-chain (AL) amyloidosis|main light-chain (AL) amyloidosis regimen page]] to find other regimens.
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? Please go to the [[Light-chain (AL) amyloidosis|main light-chain (AL) amyloidosis regimen page]] to find other regimens.
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
|}  
 
|}  
 
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
=First-line therapy (including transplant ineligible)=
 
=First-line therapy (including transplant ineligible)=
 
==Colchicine monotherapy {{#subobject:06983b|Regimen=1}}==
 
==Colchicine monotherapy {{#subobject:06983b|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:9ee4f6|Variant=1}}===
 
===Regimen {{#subobject:9ee4f6|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[http://www.amjmed.com/article/0002-9343(85)90521-2/pdf Kyle et al. 1985]
+
|[https://doi.org/10.1016/0002-9343(85)90521-2 Kyle et al. 1985]
|NR
+
|Not reported
 
| style="background-color:#1a9851" |Randomized (E-switch-ooc)
 
| style="background-color:#1a9851" |Randomized (E-switch-ooc)
 
|[[#Melphalan_.26_Prednisone_.28MP.29|MP]]
 
|[[#Melphalan_.26_Prednisone_.28MP.29|MP]]
| style="background-color:#ffffbf" |Seems not superior
+
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
|-
 
|-
|[https://www.amjmed.com/article/0002-9343(87)90222-1/pdf Cohen et al. 1987]
+
|[https://www.amjmed.com/article/0002-9343(87)90222-1 Cohen et al. 1987]
 
|1976-1983
 
|1976-1983
 
| style="background-color:#91cf61" |Non-randomized
 
| style="background-color:#91cf61" |Non-randomized
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| style="background-color:#d3d3d3" |
 
| style="background-color:#d3d3d3" |
 
|-
 
|-
| rowspan="2" |[https://www.nejm.org/doi/full/10.1056/NEJM199704243361702 Kyle et al. 1997]
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| rowspan="2" |[https://doi.org/10.1056/NEJM199704243361702 Kyle et al. 1997]
 
|rowspan=2|1982-1992
 
|rowspan=2|1982-1992
 
| rowspan="2" style="background-color:#1a9851" |Phase 3 (C)
 
| rowspan="2" style="background-color:#1a9851" |Phase 3 (C)
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| style="background-color:#d73027" |Inferior OS
 
| style="background-color:#d73027" |Inferior OS
 
|-
 
|-
|2. [[#MP_.26_Colchicine_88|Melphalan, Prednisone, Colchicine]]
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|2. [[#MP_.26_Colchicine_888|Melphalan, Prednisone, Colchicine]]
 
| style="background-color:#d73027" |Inferior OS
 
| style="background-color:#d73027" |Inferior OS
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Colchicine (Colcrys)]]
+
*[[Colchicine (Colcrys)]] 0.6 mg PO twice per day
 
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'''Continued indefinitely'''
 +
</div></div>
 
===References===
 
===References===
# 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. [http://www.amjmed.com/article/0002-9343(85)90521-2/pdf link to original article] [https://pubmed.ncbi.nlm.nih.gov/3934968 PubMed]
+
# 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. [https://doi.org/10.1016/0002-9343(85)90521-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3934968/ PubMed]
# 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. [https://www.amjmed.com/article/0002-9343(87)90222-1/pdf link to original article] [https://pubmed.ncbi.nlm.nih.gov/3605135 PubMed]
+
# 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. [https://www.amjmed.com/article/0002-9343(87)90222-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3605135/ PubMed]
# 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. [https://www.nejm.org/doi/full/10.1056/NEJM199704243361702 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9110907 PubMed]
+
# 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. [https://doi.org/10.1056/NEJM199704243361702 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9110907/ PubMed]
  
 
==Melphalan & Prednisone (MP) {{#subobject:946da1|Regimen=1}}==
 
==Melphalan & Prednisone (MP) {{#subobject:946da1|Regimen=1}}==
 
 
MP: '''<u>M</u>'''elphalan & '''<u>P</u>'''rednisone
 
MP: '''<u>M</u>'''elphalan & '''<u>P</u>'''rednisone
 +
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:b1471a|Variant=1}}===
 
===Regimen {{#subobject:b1471a|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[http://www.bloodjournal.org/content/52/4/818.long Kyle et al. 1978]
+
|[https://doi.org/10.1182/blood.V52.4.818.818 Kyle et al. 1978]
|NR
+
|Not reported
 
| style="background-color:#1a9851" |Randomized (E-esc)
 
| style="background-color:#1a9851" |Randomized (E-esc)
 
|[[Light-chain_(AL)_amyloidosis_-_null_regimens#Placebo|Placebo]]
 
|[[Light-chain_(AL)_amyloidosis_-_null_regimens#Placebo|Placebo]]
 
| style="background-color:#91cf60" |Longer time on treatment
 
| style="background-color:#91cf60" |Longer time on treatment
 
|-
 
|-
|[http://www.amjmed.com/article/0002-9343(85)90521-2/pdf Kyle et al. 1985]
+
|[https://doi.org/10.1016/0002-9343(85)90521-2 Kyle et al. 1985]
|NR
+
|Not reported
 
| style="background-color:#1a9851" |Randomized (E-switch-ooc)
 
| style="background-color:#1a9851" |Randomized (E-switch-ooc)
 
|[[#Colchicine_monotherapy|Colchicine]]
 
|[[#Colchicine_monotherapy|Colchicine]]
| style="background-color:#ffffbf" |Seems not superior
+
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
|-
 
|-
| rowspan="2" |[https://www.nejm.org/doi/full/10.1056/NEJM199704243361702 Kyle et al. 1997]
+
| rowspan="2" |[https://doi.org/10.1056/NEJM199704243361702 Kyle et al. 1997]
 
|rowspan=2|1982-1992
 
|rowspan=2|1982-1992
 
| rowspan="2" style="background-color:#1a9851" |Phase 3 (C)
 
| rowspan="2" style="background-color:#1a9851" |Phase 3 (C)
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| style="background-color:#1a9850" |Superior OS
 
| style="background-color:#1a9850" |Superior OS
 
|-
 
|-
|2. [[#MP_.26_Colchicine_99|Melphalan, Prednisone, Colchicine]]
+
|2. [[#MP_.26_Colchicine_999|Melphalan, Prednisone, Colchicine]]
| style="background-color:#ffffbf" |Seems not superior
+
| style="background-color:#ffffbf" |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.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Melphalan (Alkeran)]]  
+
*[[Melphalan (Alkeran)]] 0.15 mg/kg/day PO on days 1 to 7
 
====Glucocorticoid therapy====
 
====Glucocorticoid therapy====
*[[Prednisone (Sterapred)]]
+
*[[Prednisone (Sterapred)]] 0.8 mg/kg/day PO on days 1 to 7
 
+
'''42-day cycles'''
 +
</div></div>
 
===References===
 
===References===
# Kyle RA, Greipp PR. Primary systemic amyloidosis: comparison of melphalan and prednisone versus placebo. Blood. 1978 Oct;52(4):818-27. [http://www.bloodjournal.org/content/52/4/818.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/356916 PubMed]
+
# Kyle RA, Greipp PR. Primary systemic amyloidosis: comparison of melphalan and prednisone versus placebo. Blood. 1978 Oct;52(4):818-27. [https://doi.org/10.1182/blood.V52.4.818.818 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/356916/ PubMed]
# 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. [http://www.amjmed.com/article/0002-9343(85)90521-2/pdf link to original article] [https://pubmed.ncbi.nlm.nih.gov/3934968 PubMed]
+
# 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. [https://doi.org/10.1016/0002-9343(85)90521-2 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/3934968/ PubMed]
# 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. [https://www.nejm.org/doi/full/10.1056/NEJM199704243361702 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9110907 PubMed]
+
# 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. [https://doi.org/10.1056/NEJM199704243361702 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/9110907/ PubMed]
 
 
 
[[Category:Light-chain (AL) amyloidosis regimens]]
 
[[Category:Light-chain (AL) amyloidosis regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Plasma cell dyscrasias]]
 
[[Category:Plasma cell dyscrasias]]
 
[[Category:Historical regimens]]
 
[[Category:Historical regimens]]

Latest revision as of 12:20, 15 July 2024

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. 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 Not reported 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

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 dosing details in manuscript have been reviewed by our editors PubMed

Melphalan & Prednisone (MP)

MP: Melphalan & Prednisone

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Kyle et al. 1978 Not reported Randomized (E-esc) Placebo Longer time on treatment
Kyle et al. 1985 Not reported 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

Glucocorticoid therapy

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 dosing details in manuscript have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors PubMed