Home›Oncology› D-VCd improves hematologic CR rate to 59.5% compared to 19.2% in AL amyloidosis
D-VCd improves hematologic CR rate to 59.5% compared to 19.2% in AL amyloidosisTrial shows adding daratumumab improves outcomes for AL amyloidosis
BloodPublished August 28, 2026Study authors: Kastritis Efstathios, Palladini Giovanni, Minnema Monique C, Wechalekar Ashutosh D, Jaccard Arnaud, …PubMed ↗NCT03201965 ↗DOI ↗Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development
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Key Takeaway
Consider D-VCd for AL amyloidosis to achieve higher hematologic CR rates and improved survival outcomes.
This Phase 3 randomized controlled trial enrolled 388 patients with newly diagnosed light-chain (AL) amyloidosis. Patients were randomized to receive either subcutaneous daratumumab added to VCd (bortezomib, cyclophosphamide, and dexamethasone) followed by single-agent daratumumab every 4 weeks for up to 24 cycles, or VCd alone.
The primary outcome was hematologic complete response (CR). The D-VCd group achieved a CR rate of 59.5% compared to 19.2% in the VCd group (odds ratio, 6.03; 95% CI, 3.80-9.58; P<.0001). The median time to hematologic CR was 67.5 days for D-VCd (range, 8.0-879.0) versus 85.0 days for VCd (range, 14.0-617.0).
Secondary outcomes included significant improvements in major organ deterioration-progression-free survival (hazard ratio, 0.44; 95% CI, 0.31-0.63; P<.0001) and overall survival (hazard ratio, 0.62; 95% CI, 0.42-0.90; P =.0121) for the D-VCd group. Additionally, cardiac and renal response rates were 2 to 3 times higher with D-VCd. Adverse events were consistent with the known safety profiles for VCd and daratumumab.
While the study provides high certainty for primary and secondary outcomes, the specific rates for cardiac and renal responses were reported as 2 to 3 times higher rather than exact percentages. D-VCd is currently the only approved therapy for AL amyloidosis, and these results suggest it provides deeper and more rapid hematologic responses and organ function recovery.
How this fits prior evidence
How this fits prior evidence: This finding extends the clinical utility of daratumumab in plasma cell disorders. While prior evidence showed daratumumab improves progression-free survival in cytogenetically high-risk multiple myeloma, this trial specifically addresses the efficacy of adding daratumumab to VCd for AL amyloidosis, showing a significant improvement in both hematologic response and overall survival.
A Phase 3 clinical trial looked at 388 patients newly diagnosed with light-chain (AL) amyloidosis. Researchers compared a standard treatment (VCd) against a new method that added subcutaneous daratumumab to that same standard treatment (D-VCd).
The study found that patients who received the added daratumumab reached a complete hematologic response much faster and more often than those on the standard treatment alone. Specifically, the response rate was 59.5% for the group with added daratumumab compared to 19.2% for the standard group. The study also showed that patients on the combined treatment had significantly better survival rates and better protection against organ deterioration.
Additionally, the group receiving the added daratumumab saw much higher rates of improvement in heart and kidney function. While the treatment was reported to have a safety profile consistent with the known risks of the drugs involved, these results suggest that adding daratumumab provides a more effective way to manage the disease. Patients should speak with their doctors to see if this specific treatment plan is right for their condition.
What this means for you:
Adding daratumumab to standard treatment significantly improves response rates and survival for AL amyloidosis.
Common questions
How does adding daratumumab change treatment for AL amyloidosis?
Adding daratumumab to the standard VCd treatment resulted in a 59.5% hematologic complete response rate, compared to only 19.2% for those receiving VCd alone. It also helped patients reach these results faster, in about 67.5 days compared to 85.0 days.
Does this treatment help with heart or kidney issues?
Yes, the study found that cardiac and renal response rates were 2 to 3 times higher for patients who received the added daratumumab compared to those who received the standard treatment alone.
Is the treatment safe for patients with AL amyloidosis?
The study reported that the safety of the treatment was consistent with the known safety profiles for both the standard VCd drugs and daratumumab. You should talk to your doctor about specific risks for your health.
In the primary analysis of ANDROMEDA, addition of subcutaneous daratumumab to VCd (bortezomib, cyclophosphamide, and dexamethasone; D-VCd) significantly improved hematologic complete response (CR) rate vs VCd, establishing D-VCd as the only approved therapy for light-chain (AL) amyloidosis. We present results from the preplanned final analysis. In this phase 3 trial, we randomly assigned 388 patients with newly diagnosed AL amyloidosis to 6 cycles of VCd alone (control group) or with subcutaneous daratumumab (D-VCd) followed by single-agent daratumumab every 4 weeks for up to 24 total cycles. The primary end point was hematologic CR. The updated hematologic CR rate was 59.5% for D-VCd vs 19.2% for VCd (odds ratio, 6.03; 95% confidence interval [CI], 3.80-9.58; P< .0001). Median time to hematologic CR was shorter with D-VCd (67.5 days [range, 8.0-879.0]) vs VCd (85.0 days [range, 14.0-617.0]). With a median follow-up of 61.4 months, significant improvement was observed with D-VCd vs VCd in major organ deterioration-progression-free survival (hazard ratio, 0.44; 95% CI, 0.31-0.63; P< .0001) and overall survival (hazard ratio, 0.62; 95% CI, 0.42-0.90; P = .0121). Cardiac and renal response rates were 2 to 3 times higher with D-VCd vs VCd. Achieving hematologic or cardiac CR was associated with improved major organ deterioration-progression-free survival and overall survival. Adverse events were consistent with the known safety profiles for VCd and daratumumab. Adding daratumumab to VCd resulted in deeper and more rapid hematologic responses and organ function recovery, translating to statistically significant improvement in both overall survival and major organ deterioration-progression-free survival in newly diagnosed AL amyloidosis. This trial was registered at www.clinicaltrials.gov as #NCT03201965.
