March 7, 2018

Darzalex-Effective Treatment for Smoldering Multiple Myeloma


CancerConnect News: The use of Darzalex (daratumumab) in smoldering myeloma may be effective in delaying the time to disease progression. These results were presented at the 2017 annual meeting of the American Society of Hematology (ASH).

Multiple myeloma (MM) is the second most common blood cancer in the United States, with over 30,000 diagnoses expected in 2018.   Before the onset of MM, a condition called smoldering, or pre-myeloma, exists.  Smoldering myeloma is considered a precursor to MM, and typically does not produce any symptoms for patients. Healthcare providers often just monitor smoldering MM every 3-6 months to detect when it evolves into active MM, at which point treatment may be initiated.  Researchers are attempting to understand the best way in which to manage smoldering MM, with efforts focused on delaying the time of the disease transforming into active MM.

Daratumumab is an agent already approved for the treatment of MM that has stopped responding to prior therapies. It is targeted against a protein on the surface of MM cells, called CD-38. Daratumumab binds to the CD-38 protein, an action that causes death of the cell to which it is bound.

Researchers recently conducted a clinical trial to evaluate the potential effectiveness of daratumumab in the treatment of smoldering myeloma. The trial included 123 patients who had been diagnosed with smoldering MM a median of nearly 7 months prior to the trial. The patients were at an intermediate or high risk of their smoldering MM transforming to active MM.

Patients in the trial were divided into 3 groups: one group was treated with a long-dosing schedule of daratumumab; one group was treated with a medium-dosing schedule of daratumumab; and one group was treated with a short-dosing schedule of daratumumab.

  • Overall response rates to treatment were greatest in the group treated with the long-dosing schedule of daratumumab.
  • Although the data are not yet mature, it is estimated that at 12 months following initiation of treatment with daratumumab, 98% of patients treated with the long-dosing schedule will be alive without progression of their disease, as compared with 93% for those treated with the intermediate-dosing schedule; and 89% for those treated with the low-dosing schedule.
  • Treatment was well tolerated with no unexpected side effects.

The researchers are planning a larger clinical trial to further evaluate the use of daratumumab in smoldering MM to explore its effectiveness in delaying the time to progression to active MM.

Reference: Hofmeister C, Chari A, Cohen Y, et al. Daratumumab monotherapy for patients with intermediate or high-risk smoldering multiple myeloma (SMM): Centaurus, a randomized, open-label multicenter phase 2 study. Proceedings from the 59th annual meeting of the American Society of Hematology. Abstract #510. Retrieved from

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Tags: Multiple Myeloma, News, Uncategorized