Adding daratumumab to first-line treatment can improve progression-free survival (PFS) in transplant-ineligible patients with high-risk multiple myeloma (MM), according to research published in The Oncologist.

Researchers observed a 41% reduction in the risk of disease progression or death when daratumumab was added to first-line treatment.

The researchers conducted a pooled analysis of patient-level data from 2 randomized phase 3 clinical trials — MAIA ( Identifier: NCT02252172) and ALCYONE ( Identifier: NCT02195479).

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In ALCYONE, patients received bortezomib plus melphalan and prednisone, with or without daratumumab. In the MAIA trial, patients received lenalidomide plus dexamethasone, with or without daratumumab.

The pooled analysis included 190 patients who had newly diagnosed MM at baseline, were ineligible for autologous transplant, and had high-risk cytogenetics (ie, del[17p], t[4;14], or t[14;16]). In this group, 101 patients received daratumumab and 89 did not.

The median follow-up was 43.7 months. The median PFS was significantly longer in the daratumumab cohort than in the control cohort — 21.2 months and 19.3 months, respectively (adjusted hazard ratio, 0.59; 95% CI, 0.41-0.85; P =.0046). The 3-year PFS rate was 41.3% in the daratumumab cohort and 19.9% in the control cohort.

The rate of complete response (CR) or better was 41.6% in the daratumumab cohort and 22.5% in the control cohort (relative risk [RR], 1.85; 95% CI, 1.18-2.90). The rate of minimal residual disease-negative CR was 24.8% and 5.6%, respectively (RR, 4.35; 95% CI, 1.75-10.82).

When the researchers assessed PFS by response status, they found the benefit with daratumumab was only present among patients who had a best response of CR or better.

Among patients who achieved a CR or better, the median PFS was not reached for the daratumumab cohort and was 31 months for the control cohort. Among patients who did not achieve a CR, the median PFS was 16.4 months and 15.6 months, respectively.

“These findings provide additional evidence supporting the use of daratumumab-based treatment in this high-risk population of patients with a particularly high unmet need,” the researchers wrote.

Disclosures: This research was supported by Janssen Scientific Affairs, LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Jakubowiak AJ, Kumar S, Medhekar R, et al. Daratumumab improves depth of response and progression-free survival in transplant-ineligible, high-risk, newly diagnosed multiple myeloma. Oncologist. Published online April 24, 2022. doi:10.1093/oncolo/oyac067