Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis.
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Kastritis Efstathios, Palladini Giovanni, Minnema Monique C, Wechalekar Ashutosh D, Jaccard Arnaud, Lee Hans C, Sanchorawala Vaishali, Gibbs Simon, Mollee Peter, Venner Christopher P, Lu Jin, Schönland Stefan, Gatt Moshe E, Suzuki Kenshi, Kim Kihyun, Cibeira M Teresa, Beksac Meral, Libby Edward, Valent Jason, Hungria Vania, Wong Sandy W, Rosenzweig Michael, Bumma Naresh, Huart Antoine, Dimopoulos Meletios A, Bhutani Divaya, Waxman Adam J, Goodman Stacey A, Zonder Jeffrey A, Lam Selay, Song Kevin, Hansen Timon, Manier Salomon, Roeloffzen Wilfried, Jamroziak Krzysztof, Kwok Fiona, Shimazaki Chihiro, Kim Jin-Seok, Crusoe Edvan, Ahmadi Tahamtan, Tran NamPhuong, Qin Xiang, Vasey Sandra Y, Tromp Brenda, Schecter Jordan M, Weiss Brendan M, Zhuang Sen H, Vermeulen Jessica, Merlini Giampaolo, Comenzo Raymond L, ANDROMEDA Trial Investigators
Аннотация
METHODS: We randomly assigned patients with newly diagnosed AL amyloidosis to receive six cycles of bortezomib, cyclophosphamide, and dexamethasone either alone (control group) or with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles (daratumumab group). The primary end point was a hematologic complete response.
RESULTS: A total of 388 patients underwent randomization. The median follow-up was 11.4 months. The percentage of patients who had a hematologic complete response was significantly higher in the daratumumab group than in the control group (53.3% vs. 18.1%) (relative risk ratio, 2.9; 95% confidence interval [CI], 2.1 to 4.1; P<0.001). Survival free from major organ deterioration or hematologic progression favored the daratumumab group (hazard ratio for major organ deterioration, hematologic progression, or death, 0.58; 95% CI, 0.36 to 0.93; P = 0.02). At 6 months, more cardiac and renal responses occurred in the daratumumab group than in the control group (41.5% vs. 22.2% and 53.0% vs. 23.9%, respectively). The four most common grade 3 or 4 adverse events were lymphopenia (13.0% in the daratumumab group and 10.1% in the control group), pneumonia (7.8% and 4.3%, respectively), cardiac failure (6.2% and 4.8%), and diarrhea (5.7% and 3.7%). Systemic administration-related reactions to daratumumab occurred in 7.3% of the patients. A total of 56 patients died (27 in the daratumumab group and 29 in the control group), most due to amyloidosis-related cardiomyopathy.
CONCLUSIONS: Among patients with newly diagnosed AL amyloidosis, the addition of daratumumab to bortezomib, cyclophosphamide, and dexamethasone was associated with higher frequencies of hematologic complete response and survival free from major organ deterioration or hematologic progression. (Funded by Janssen Research and Development; ANDROMEDA ClinicalTrials.gov number, NCT03201965.).