. 2017 Aug 24;8:33–38. doi: 10.1016/j.conctc.2017.08.012

Table 1.

Systemic AL amyloidosis.

	Baseline^a	Months												End of Treatment (within 30 days)
	Baseline^a	1^a	2	3	4	5	6	7	8	9	10	11	12	End of Treatment (within 30 days)
Inclusion & Exclusion criteria	✕
Informed consent	✕
H & PE^d	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Vital signs^e eee	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
ECOG performance status	✕			✕			✕			✕			✕	✕
NYHA class	✕						✕^k						✕^k	✕^k
Complete Blood Count with differential	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Serum chemistries panel^f	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Amyloid subtype^b	✕
β₂ microglobulin	✕
Myeloma screening panel^g	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Bone marrow aspirate/biopsy	✕^j
Β-HCG serum pregnancy test^h	✕
Bone surveyⁿ	✕^j
2D echocardiogram (IVS + LVEF)	✕						✕^k							✕^k,^c
Troponin-T, NT-proBNP	✕	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k	✕^k,^c
Abdominal Imaging	✕^j						✕^l							✕^l^,^c
24 h urinary protein with UPEP/immunofixation	✕			✕^m			✕^m			✕^m				✕^m,^c
Toxicity assessment		✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Research specimensⁱ	✕							✕						✕^c
Patient-reported outcomes^o	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕

H & PE = history and physical examination.

ECOG- Eastern Co-operative Oncology Group performance score.

NYHA- New York Heart Association Class.

2D echocardiogram- Two-dimensional transthoracic echocardiogram.

IVS- interventricular septal thickness.

LVEF- left ventricular ejection fraction.

Baseline and Month 1 can occur within 7 days without the need to repeat the Month 1 testing.

If a patient has had amyloid subtyping performed in the past, this need not be repeated again.

May be performed anytime during cycle 12 or within 30 days of the last dose of doxycycline.

History is only required at baseline.

Vital signs: blood pressure, pulse rate, respiratory rate and temperature.

Serum chemistries panel: electrolytes, BUN, ALT, AST, creatinine, bilirubin, alkaline phosphatase, LDH, albumin, uric acid. Electrolytes to include sodium, potassium, chloride, carbon dioxide, and calcium.

Myeloma screening panel includes serum protein electrophoresis, immunofixation electrophoresis, free light chain assay.

Females of reproductive potential only.

ⁱ

Peripheral blood specimens: 6 mL blood in heparin containing tube at indicated time points and send to the Tissue Bank at MCW after processing.

May be performed within 3 months of baseline.

Cardiac assessment will be followed only if baseline cardiac involvement.

Abdominal imaging will be repeated only if baseline liver involvement.

Urinary studies will be repeated only if baseline renal involvement.

ⁿ

Not required if ≤ 10% plasma cells in bone marrow.

PROMIS Global Health Scale, PROMIS-29, PROMIS Fatigue-8 short forms.