Daratumumab (Darzalex) for the treatment of multiple myeloma in adults who have already had treatment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether daratumumab (trade name: Darzalex) has any advantages or disadvantages compared with the current standard treatments for people with multiple myeloma. The drug manufacturer provided IQWiG with two relevant studies. Both studies included only patients who had already had at least one treatment for multiple myeloma.

In one of the studies, daratumumab was used in combination with the drugs lenalidomide and dexamethasone. Of the 569 patients who took part in the study, 286 were given daratumumab in combination with lenalidomide and dexamethasone, and 283 patients were only given lenalidomide and dexamethasone.

In the other study, daratumumab was used in combination with bortezomib and dexamethasone. Of the 498 participants, 251 were given daratumumab in combination with bortezomib and dexamethasone, and 247 patients were only given bortezomib and dexamethasone.

What are the advantages of daratumumab?

Life expectancy: The studies show that daratumumab can prolong life. During an average (median) observation period of about 12 to 17 months, about 15 out of 100 patients who received both the standard treatment and daratumumab passed away. During the same observation period, about 20 to 24 out of 100 patients who were not given daratumumab passed away.

What are the disadvantages of daratumumab?

Serious side effects: The studies show that patients who use daratumumab in addition to the standard treatment are more likely to have severe side effects. These side effects occurred in 79 to 83 out of 100 people who received daratumumab, and in about 63 to 75 out of 100 people who didn't receive daratumumab.

Side effects:

  • Gastrointestinal (stomach and bowel) problems: The studies suggest that daratumumab has an overall disadvantage here: About 64 to 78 out of 100 patients who used daratumumab developed gastrointestinal problems as a result of the treatment. Without daratumumab, about 47 to 62 out of 100 patients had this side effect.
  • Problems affecting the airways or chest: The studies suggest that daratumumab has a disadvantage here too: About 56 to 62 out of 100 patients who received daratumumab developed problems affecting their airways or chest as a result of the treatment. Without daratumumab, about 33 to 42 out of 100 patients were affected.

No difference

General health and multiple myeloma symptoms: There was no difference between the treatments in terms of general health and various disease-related symptoms, such as exhaustion, nausea and vomiting, pain, shortness of breath, sleep problems, loss of appetite, constipation and diarrhea.

Health-related quality of life: There was no overall difference between the treatments here.

Side effects:

  • Febrile neutropenia: There was no real difference between the treatments here, either. Febrile neutropenia is the development of fever in a patient who doesn’t have enough immune cells.
  • Peripheral sensory neuropathy: There was no difference between the treatments here. In peripheral sensory neuropathy, the nerves in the body that aren't part of the brain or spinal cord (peripheral nerves) are damaged. This can lead to symptoms such as abnormal sensations, pain, partial paralysis, weakness or dizziness.
  • Treatment stopped due to side effects: No difference was found here, either.

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (multiple myeloma) – Addendum to Commission A17-40; Commission A18-03. February 2, 2018. (IQWiG reports; Volume 589).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-40. November 13, 2017. (IQWiG reports; Volume 562).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on January 2, 2019
Next planned update: 2022

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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