Daratumumab (Darzalex) as first-line treatment in combination with bortezomib, melphalan and prednisone if a stem cell transplantation is not an option

In 2019 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of newly diagnosed multiple myeloma in people who can't have a stem cell transplant.

The manufacturer gave IQWiG one still ongoing study involving 706 participants that provided at least preliminary answers to some questions. One half of the participants were given treatment with the combination bortezomib / melphalan / prednisone, and the other group received this combination plus daratumumab. All of the patients were in relatively good health otherwise.

What are the advantages of daratumumab?

Life expectancy: The study suggests that daratumumab can increase life expectancy. When given daratumumab in addition to the other medications, about 17 out of 100 people died within an average (median value) of two years, compared to about 23 out of 100 people who received the standard treatment.

Treatment stopped due to side effects: The study suggests that daratumumab has an advantage here. About 6 out of 100 people who had treatment with daratumumab as well as the other medications stopped their treatment due to the side effects, compared to about 9 out of 100 people who had the standard treatment.

What are the disadvantages of daratumumab?

Severe infections, parasitic diseases and vascular (blood vessel) diseases: Based on the preliminary results, the study suggests that daratumumab has a disadvantage in terms of these severe side effects when compared with the standard treatment.

Problems affecting the airways and chest: The study suggests that using daratumumab in addition to the other medications has a disadvantage in terms of these side effects, too.

No difference

There was no difference between the treatment groups in terms of the following:

  • General health and multiple myeloma symptoms such as nausea and vomiting, pain, shortness of breath, sleep problems, loss of appetite, constipation and diarrhea.
  • Health-related quality of life
  • Severe side effects

There was no real difference between the treatments in terms of tiredness () either.

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 A18-66. December 20, 2018. (IQWiG reports; Volume 698).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (multiple myeloma) – Addendum to Commission A18-66; Commission A19-16. February 28, 2019. (IQWiG reports; Volume 732).

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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Updated on July 2, 2020
Next planned update: 2023

Authors/Publishers:

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

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