Progression-Free Survival and Minimal Residual Disease Negativity May Result From Combination Therapy in Newly Diagnosed Multiple Myeloma

Combination therapy with Kyprolis (carfilzomib), Revlimid (lenalidomide), dexamethasone and Darzalex (daratumumab) for patients with newly diagnosed multiple myeloma contributed to high rates of minimal residual disease negativity and progression-free survival, according to findings from a trial published in JAMA Oncology.

In this single-center, phase 2 trial, researchers analyzed data from 41 patients (median age, 59 years; 61% women; 49% high-risk multiple melanoma) with newly diagnosed multiple myeloma. All patients were treated with weekly Kyprolis, Revlimid, dexamethasone and Darzalex using a specific dosing schedule, all of which was completed within eight 28-day cycles.

Researchers assessed the rate of minimal residual disease (very small number of cancer cells in the body during or after completing treatment) negativity after patients completed eight cycles of weekly Kyprolis, Revlimid, dexamethasone and Darzalex. Other areas of interest included tolerability and safety, rates of clinical response and estimates of progression-free survival (time during and after treatment when the patient lives without disease progression) and overall survival (time from diagnosis or treatment start when patients are alive). Follow-up was conducted for a median of 11 months.

This trial was considered successful, according to the researchers, because minimal residual disease negativity occurred in 71% of patients. This was achieved in a median of six cycles of treatment.

The overall response rate for patients in the trial was 100%, with a very good partial or complete response rate of 95%. The progression-free survival at one year was 98% with an overall survival rate of 100%.

The most common severe or life-threatening side effects included rash (9%), low number of a type of white blood cell called neutrophils (27%), increased alanine aminotransferase level indicating liver damage (4%) and lung infection (7%). No deaths occurred during the trial.

“Building on these promising results, we have developed a large randomized multicenter clinical trial (ADVANCE) comparing (weekly Kyprolis, Revlimid, dexamethasone and Darzalex) with current standard of care for patients with newly diagnosed multiple myeloma, and the trial has already opened for enrollment,” the study authors wrote.

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