Table 1.
Diagnosis (September 2014) | First relapse (October 2017) | Second relapse (December 2019) | ||||||
BCMA–CART ARI0002h (screening) |
+1 month ARI0002h | +6 months ARI0002h | +12 months ARI0002h | |||||
CRAB (other symptoms) | Present (anemia, bone disease) | Present (anemia) | Absent, bilateral lower extremity edema | |||||
Serum M-protein (g/L) | 59.7 | 0 | 0 | 17.6 | 20.7 | 4.7 | 0 | 0 |
Serum lambda FLC (5.71–26.3 mg/L) |
1070 | 7 | 7 | 93 | 231 | <0.05 | <0.05 | 14 |
Proteinuria Urine M-protein (mg/24 hours) |
2043 1052 |
268 0 |
144 0 |
94 0 |
2626 307 |
1777 0 |
1185 0 |
797 0 |
Creatinine (<1.3 mg/dL) eGFR (>60 mL/min/1.73 m2) |
0.81 75 |
0.52 >90 |
0.55 >90 |
0.67 >90 |
0.60 >90 |
0.67 >90 |
0.81 75 |
0.91 66 |
NT-proBNP (<125 pg/mL) Troponine I (<45.2 ng/L) |
ND ND |
ND ND |
ND ND |
ND ND |
211 7.2 |
ND ND |
250 8.6 |
ND ND |
Serum and urine immunofixation | IgA lambda IgA lambda |
IgA lambda Negative |
IgG kappa Negative |
IgA lambda IgA lambda |
IgA lambda IgA lambda |
IgA lambda IgA lambda |
Negative Negative |
IgG kappa Kappa FLC |
Plasma cells (%) in bone marrow aspiration before treatment | 82 Abnormal phenotype |
1 Negative MRD |
1 Negative MRD |
25 Abnormal phenotype |
23 Abnormal phenotype |
0 Negative MRD |
0 Negative MRD |
1 Negative MRD |
Treatment | Induction VRD ×6 |
ASCT | Consolidation VRD ×2+maintenance I-Rd (CT) ×19 |
D-Kd x14, since February 2019 D alone. | BCMA–CART ARI0002h | |||
Best response (IMWG criteria) after treatment | VGPR | VGPR (at 3 months) |
sCR | VGPR | N/A | PR | sCR | sCR |
CRAB includes multiple myeloma-related symptoms.
ASCT, autologous stem cell transplantation; BCMA, B-cell maturation antigen; CRAB, hypercalcemia, renal failure, anemia and bone fracture; CT, clinical trial; D, daratumumab; eGFR, estimated glomerular filtration rate; I, ixazomib; IMWG, International Myeloma Working Group; K, carfilzomib; MRD, minimal residual disease; N/A, not applicable; ND, data not available; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; PR, partial response; sCR, stringent complete response; VGPR, very good partial response; VRD, bortezomib, lenalidomide and dexamethasone.