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On Saturday 15 June at the 24th Congress of the European Hematology Association (EHA), Maria Victoria Mateos from the University Hospital of Salamanca, Salamanca, ES, presented the results of the GEM-CESAR phase II clinical trial. This study assessed the curative potential of carfilzomib, lenalidomide, and dexamethasone combination in patients with high-risk smoldering multiple myeloma (SMM).1
SMM is an asymptomatic intermediate between active myeloma and the precursor stage, monoclonal gammopathy of undetermined significance (MGUS). Both the Spanish Myeloma Group and that of the Mayo Clinic (US), have shown that the early addition of lenalidomide to treatment significantly prevents SMM progression to active MM.2,3 This trial sought to further assess the potential benefit of lenalidomide plus carfilzomib and dexamethasone (KRd) in SMM.
The primary endpoint of this single-arm trial was to increase minimal residual disease (MRD) negativity from 34% to ≥50%, as assessed by next generation flow cytometry (NGF). MRD was measured at three and five years post high-dose therapy (HDT) and autologous stem cell transplantation (ASCT; HDT-ASCT). Secondary objectives included response rates, time-to-progression (TTP), progression-free survival (PFS), overall survival (OS), and safety.
PCBMI, plasma cells bone marrow infiltration; sFLC, serum free light chain |
|
Baseline characteristic |
Patient cohort (N=90) |
---|---|
Median age (range) |
59 (33–70) |
PCBMI (range) |
22% (10–80) |
High-risk classification by: Mayo Clinic model Spanish model Both |
21% 52% 27% |
Ultra high-risk patients with one or more of following: sFLC>100 >1 focal lesion on MRI ≥60% PCBMI |
20% 12% 8% |
PET without lytic lesions |
6% |
Cytogenetic abnormalities: Standard risk High-risk Unknown |
62% 23% 14% |
CR, complete response; MRD, minimum residual disease; ORR, overall response rate; PD, progressive disease; PR, partial response; SDS, stable disease; VGPR, very good partial response | |||
Stage 1 |
After induction therapy (n=90) |
High-risk patients (n=60) |
Ultra high-risk patients (n=30) |
---|---|---|---|
ORR |
94% |
95% |
93% |
≥CR |
41% |
40% |
43% |
VGPR |
39% |
42% |
33% |
PR |
14% |
13% |
17% |
SD |
1% |
2% |
- |
PD |
3% |
2% |
3% |
MRD negativity rate |
30% |
28% |
33% |
CR, complete response; HDT-ASCT, high-dose therapy autologous stem cell transplantation; MRD, minimum residual disease; ORR, overall response rate; PD, progressive disease; PR, partial response; SDS, stable disease; VGPR, very good partial response | |||
Stage 2 |
After HDT-ASCT (n=83)
|
High-risk patients (n=55) |
Ultra high-risk patients (n=28) |
---|---|---|---|
ORR |
99% |
95% |
100% |
≥CR |
64% |
64% |
64% |
VGPR |
22% |
22% |
21% |
PR |
13% |
13% |
14% |
SD |
1% |
2% |
- |
PD |
- |
- |
- |
MRD negativity rate |
56% |
58% |
54% |
CR, complete response; MRD, minimum residual disease; ORR, overall response rate; PD, progressive disease; PR, partial response; SDS, stable disease; VGPR, very good partial response | |||
Stage 2 |
After consolidation therapy (n=83)
|
High-risk patients (n=55) |
Ultra high-risk patients (n=28) |
---|---|---|---|
ORR |
100% |
100% |
100% |
≥CR |
76% |
78% |
71% |
VGPR |
18% |
18% |
18% |
PR |
6% |
4% |
11% |
SD |
- |
- |
- |
PD |
- |
- |
- |
MRD negativity rate |
61% |
65% |
53% |
Consolidation & maintenance (stages 3 & 4)
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