Table 2 Methodology and findings of published flow cytometry-based MRD studies in AL amyloidosis and of the present report.

From: Minimal residual disease negativity by next-generation flow cytometry is associated with improved organ response in AL amyloidosis

Study

NGF technique

Sensitivity

N. pts

Pts. in CR N (%)

ASCT N (%)

Eligibility criteria

Median time from CR to MRD assessment

MRDpos N (%)

Median follow-up from MRD assessment

% Hematologic progression POS vs NEG

Cardiac response N/evaluable (%) POS vs NEG

Renal response N/evaluable (%) POS vs NEG

Kastritis et al.24

EuroFlow

Range:

2–3.1 × 10−6

Median 2.3 × 10−6

20

20

(100%)

8

(40%)

CR+ negative BM biopsy

36 months

12

(60%)

NA

NA

1/4(25%) vs 3/3(100%)

6/10(60%)

vs 6/8 (75%)

Muchtar et al.26

7-color MFC

Range:

1 × 10−4–2 × 10−5

82

16

(20%)

69

(84%)

End of first-line treatment

NA

58

(71%)a

Subgroup of CR pts.:

8 (50%)

NA

3-year PFS:

28% vs

88%

Subgroup of CR pts.:

33% vs

100%

Subgroup of VGPR/CR pts.:

10/12 (83%) vs 8/8 (100%)

Subgroup of VGPR/CR pts.:

13/19 (68%) vs 14/14 (100%)

Sidana et al.25

Euroflow

Range: ≥1 × 10−5–10−6

44

20

(45%)

25

(57%)

MRD testing within 2 years from start of therapy

NA

14

(36%)b

Subgroup of CR pts.:

5 (25%)

14 months

Estimated 1-year PFS:

64% vs

100%

2/7 (22%)

vs 8/12 (67%)

8/9 (89%) vs

11/16 (69%)

Staron et al.28

2-tube, 10-color antibody panel

Range: 1 × 10−4–1 × 10−5

65

65 (100%)

32 (49%)

CR at previous evaluation

71 months for MRD negative

32 months for MRD positive

36 (55%)

NA

NA

10/17 (59%) vs 9/12 (75%)

18/28 (64%) vs 21/24 (88%)

Kastritis et al.27

Euroflow

Range: 2 × 10−6–3.1 × 10−6

52

52 (100%)

7 (14%)

CR after their primary therapy

6 months (range 3–12)

28 (55%)

24 months

21% vs 0%

11/15 (73%) vs 10/10 (100%)

14/16 (87.5%) vs 15/17 (88%)

Current study

Euroflow

10−6: 76%

10−5: 24%

92

92

(100%)

35

(38%)

CR confirmed at least 6 months after end of therapy

MRD pos:

13 months;

MRD neg:

12 months

50

(54%)

23 months

26% vs

2%

18/19 (95%) vs

20/28 (71%)

23/25 (92%)

vs 15/26 (57%)

  1. ASCT autologous stem cell transplantation, BM bone marrow, CR complete response (hematologic), MFC multiparametric flow cytometry, MRD minimal residual disease, NA not available, NGF next-generation flow, NEG negative, POS positive, PFS progression-free survival, pts. patients, VGPR very good partial response.
  2. aMRD negativity in 16 out of 22 patients in VGPR.
  3. bMRD negativity in 2 patients with less than VGPR and in 11 out of 22 patients in VGPR.