Triple Therapy with Darzalex Improves Pain, Quality of Life in Newly Diagnosed Multiple Myeloma Ineligible for Stem Cell Transplantation

Treatment with Darzalex (daratumumab), Revlimid (lenalidomide) and dexamethasone in patients newly diagnosed with multiple myeloma who are ineligible for stem-cell transplantation contributed to improvements in outcomes including pain compared with Revlimid (lenalidomide) and dexamethasone.

“As the treatment landscape evolves for patients with (newly diagnosed multiple myeloma), the goals of first-line therapy should include improvement or maintenance of (health-related quality of life) reflecting clinical efficacy,” the study authors wrote in a study published in the Journal of Clinical Oncology. “Addition of (Darzalex) to (standard of care) regimens supports these treatment goals in (transplant-ineligible) patients with (newly diagnosed multiple myeloma).”

In this phase 3 study, researchers treated 737 patients (median age, 73 years) newly diagnosed with multiple myeloma who are ineligible for stem-cell transplantation with Darzalex, Revlimid and dexamethasone (368 patients) or Revlimid and dexamethasone (369 patients). Both treatment groups received 25 mg of Revlimid once per day for the first 21 days of a 28-day cycle, in addition to 40 mg of dexamethasone intravenously or orally once per week until unacceptable toxicity or disease progression. Researchers gave patients 16 mg/kg of Darzalex intravenously once per week for the first eight weeks in cycles one and two; every other week for 16 weeks in cycles three through six; and every four weeks starting at cycle seven onward, which was also given until unacceptable toxicity or disease progression.

Patients completed two different questionnaires — European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-Item and the EuroQol Five-Dimensional Descriptive System — periodically throughout the study for researchers to collect information on quality of life. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-Item assesses five functional scales such as emotional and physical factors; three symptoms including pain, fatigue and nausea/vomiting; global health status; and single items such as appetite loss and financial difficulties. EuroQol Five-Dimensional Descriptive System evaluates several aspects of health status including usual activities, mobility, pain/discomfort, self-care and anxiety/depression.

The rate of compliance to completing both questionnaires was high at the beginning of the study (> 90%) and at 12 months (> 78%).

Although both groups had improvements in global health scores, improvements were greater in patients taking Darzalex, Revlimid and dexamethasone regardless of functional status, age and depth of response to the treatment.

Compared with the Revlimid and dexamethasone group, patients in the Darzalex, Revlimid and dexamethasone group had a greater reduction in pain starting at the third cycle and was maintained throughout cycle 12. This benefit was greater in patients treated with Darzalex, Revlimid and dexamethasone regardless of functional status, age and depth of treatment response.

Both groups had improvements in patient-reported outcomes based on the EuroQol Five-Dimensional Descriptive System.

“Early and sustained pain relief has been shown to yield greater treatment satisfaction in patients with cancer yet remains an unmet need,” the study authors wrote. “These results may provide a meaningful metric for patients and physicians to inform therapeutic decisions in clinical practice.”

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