What the trial was testing
The ANDROMEDA enrolled 416 patients with amyloidosis. The study was sponsored by Janssen Research & Development, LLC and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Complete response rates reached 53% with daratumumab versus 18% without it.
The New England journal of medicine · 2021 · NCT03201965
These findings — that adding daratumumab to standard chemotherapy nearly tripled complete remission rates in newly diagnosed amyloidosis patients. — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 416 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with amyloidosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This treatment significantly improved how many patients achieved complete remission of their amyloidosis. It also helped prevent organ damage, which is a major concern with this disease. This was a large confirmatory trial, and the results support using this combination as a standard treatment option for newly diagnosed patients.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open amyloidosis trials
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.
Thailand ATTR-CM Registry
The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand.