ANDROMEDA
Trial question
What is the role of daratumumab-based treatment in patients with newly diagnosed immunoglobulin light-chain amyloidosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 388
388 patients (163 female, 225 male)
Inclusion criteria: patients with newly diagnosed immunoglobulin light-chain amyloidosis
Key exclusion criteria: prior therapy for AL amyloidosis or multiple myeloma, previous or current diagnosis of symptomatic multiple myeloma, significant cardiovascular conditions, eGFR < 20 mL/min/1.73 m² of BSA
Interventions
N=195 daratumumab (six cycles of bortezomib, cyclophosphamide, and dexamethasone with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles)
N=193 control (six cycles of bortezomib, cyclophosphamide, and dexamethasone alone)
Primary outcome
Hematologic complete response
53.3
18.1
53.3 %
40.0 %
26.6 %
13.3 %
0.0 %
Daratumumab
Control
Significant increase ▲
NNT = 2
Significant increase in hematologic complete response (53.3% vs. 18.1%; RR 2.9, 95% CI 2.1 to 4.1)
Secondary outcomes
Significant decrease in major organ deterioration or hematologic progression (17.4% vs. 27.5%; HR 0.58, 95% CI 0.36 to 0.93)
Safety outcomes
No significant differences in lymphopenia, cardiac failure, diarrhea, death.
Conclusion
In patients with newly diagnosed immunoglobulin light-chain amyloidosis, daratumumab was superior to control with respect to hematologic complete response.
Reference
Efstathios Kastritis, Giovanni Palladini, Monique C Minnema et al. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. N Engl J Med. 2021 Jul 1;385(1):46-58.
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