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ASCO 2022: Daratumumab-Based Therapy for High-Risk Smoldering Myeloma

By: Lauren Harrison, MD, MS
Posted: Friday, June 10, 2022

Combination therapy consisting of the monoclonal antibody daratumumab plus bortezomib, lenalidomide, and dexamethasone was well tolerated and demonstrated significant activity among patients with high-risk smoldering multiple myeloma. These responses deepened over time, according to Omar Nadeem, MD, of the Dana-Farber Cancer Institute, Boston, who presented these results on behalf of his colleagues at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8040).

This phase II, single-arm trial enrolled 20 patients with high-risk smoldering multiple myeloma. Patients were administered daratumumab subcutaneously at the standard dose and schedule along with weekly bortezomib on days 1, 8, and 15 for the first six cycles, then biweekly until cycle 24. Lenalidomide was given on days 1 to 21, and dexamethasone was administered weekly. After 6 weeks of therapy, all eligible patients underwent stem cell collection.

The overall response rate was 90%, with 40% of patients achieving a partial response; 25%, a very good partial response; and 25%, a complete response. According to the investigators, all responses deepened over time. Eight patients were evaluated for measurable residual disease (MRD) status. At a threshold of 10-5, four of eight patients achieved MRD negativity, and two of eight reached it at a threshold of 10-6. Stem cells were collected in all patients and yielded a median of 5.78 x 106 CD34+/kg cells. No patients experienced disease progression during treatment.

The most common toxicities of any grade among this cohort included neutropenia (65%), decreased white blood cell count (55%), insomnia (50%), constipation (45%), and hypophosphatemia (45%). Common ≥ grade 3 adverse events included neutropenia (15%), increased alanine transaminase levels (5%), thrombocytopenia (5%), hyperglycemia (5%), hypertension (5%), diarrhea (5%), and syncope (5%). No patients needed to discontinue therapy as a result of toxicity.

Disclosure: For a full list of authors’ disclosures, visit

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